BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number 83786 |
Device Problems
Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
Event Type
malfunction
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Event Description
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Reportable based on device analysis completed on 29feb2024.It was reported that the coil could not be advanced from the catheter.A 12mm x 40cm interlock-35 coil was selected for splenic artery embolization.During the course of the procedure, there was something wrong at the entrance of the delivery system and the coil could not be advanced any more.The coil was withdrawn from patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable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 a detached arm coil.
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Manufacturer Narrative
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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 and stretched at the coil arm, all primary coil and zap tip section.Also, the arm coil was detached.The original pouch was returned, and it was observed that the pouch information matches with the complaint information.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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Search Alerts/Recalls
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