BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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Model Number 83786 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: only the main coil was returned.It was observed that the main coil was bent, detached and stretched at the coil arm and primary coil 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.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the pusher wire and main coil revealed the components were within specification.No other issues were identified during the product analysis.
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Event Description
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Reportable based on device analysis completed on 05feb2024.It was reported that the coil could not cross the angled part of the catheter.The target lesion was located in the internal iliac artery.A 10mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that the coil could not cross the angled part of the catheter.The procedure was completed with a different device.No patient complications were reported.However, it was revealed that the mail coil was detached.
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