MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.A pusher wire, coil and introducer sheath were returned for this complaint.The coil and pusher wire arms were not interlocked.The twist lock of the introducer sheath had been opened.The pusher wire was inspected and it was found kinked.The coil was returned stretched and kinked.No more damages were found.Microscopic inspection of the pusher wire was performed and observed that the proximal end has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.Dimensional inspection of the main coil were performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications, however there were lacking fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 31mar2020.It was reported that device stuck in the microcatheter.The target lesion was located in the internal iliac artery.A 5mm x 15cm interlock was selected for use.During procedure, it was noted that coil got stuck in the distal part of the microcatheter and was removed as per usual.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed missing fiber bundles.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9957708
• Report Number: 2134265-2020-05004
• Device Sequence Number: 16793499
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024870234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1