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This screener tracks medical device adverse events.

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Ticker Notified Product Product Category Product Brand Single-Use Ignored? Source Country Description
BSX-PA 10/31/2024 EXPRESS LD VASCULAR Medical Device — ✘ O CH A2: age at time of event: 18 years or older.
BSX 10/31/2024 EXPRESS LD VASCULAR Medical Device — ✘ O CH A2: age at time of event: 18 years or older.
BSX-PA 10/31/2024 INTERLOCK Medical Device — ✘ O CH A2 - age at time of event: (b)(6) years or older. E1 - initial reporter address: shanghai jiao tong university school of medicine. Device evaluated by mfr: the interlock was returned for analysis. Visual and microscopic inspections were performed, and it was observed that the main coil, the introducer sheath and the pusher wire were returned. It was observed that the main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached. The functional could not be performed due the main coil and the pusher wire are not interlocking. Dimensional inspection of the main coil revealed the components were within specifications. No other issues were identified during the product analysis.
BSX 10/31/2024 INTERLOCK Medical Device — ✘ O CH A2 - age at time of event: (b)(6) years or older. E1 - initial reporter address: shanghai jiao tong university school of medicine. Device evaluated by mfr: the interlock was returned for analysis. Visual and microscopic inspections were performed, and it was observed that the main coil, the introducer sheath and the pusher wire were returned. It was observed that the main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached. The functional could not be performed due the main coil and the pusher wire are not interlocking. Dimensional inspection of the main coil revealed the components were within specifications. No other issues were identified during the product analysis.
BSX 10/31/2024 INTERLOCK-35 Medical Device — ✘ O CH A2 - age at time of event: (b)(6) years or older e1 - initial reporter facility name: (b)(6) e1 - initial reporter address 1: (b)(6). Device evaluated by mfr: the interlock. 035 was returned for analysis. It was observed that the main coil, the rhv, the introducer sheath and the delivery wire were returned for evaluation. It was observed that the main coil was bent and stretched at the coil arm, primary coil and zap tip section, moreover the zap tip was detached. The main coil was detached, bent and stretched. The functional could not be performed due the main coil and the pusher wire are not interlocking. Dimensional inspection of the main coil revealed the components were within specifications. No other issues were identified during the product analysis.
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