Reportable based on device analysis completed on 05feb2024.It was reported that the coil could not be pushed nor withdrawn and got detached in the catheter.Interlock-35 coil was selected for use.During the procedure, when the coil was advanced into a non-boston scientific catheter, it was noted that it was very dry and astringent.When the coil had been pushed into the patient for half, the guidewire could not move forward.During the recapture, it was found that the device could not be withdrawn to the protective sheath, and after it was withdrawn completely, the coil was detached.The procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.However, device analysis revealed that the main coil was detached at the coil arm section.
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E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual inspection was performed and it was observed that the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent, detached and stretched at the coil arm section.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed during visual inspection.The functional inspection could not be performed due to 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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