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

Model Number	83779
Medical Device Problem Codes	Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A coil, pusher wire and introducer sheath were returned for this complaint.The twist lock of the introducer sheath had been opened.The introducer sheath was inspected and it was returned stretched.The coil was returned stretched and kinked.The pusher wire was inspected and it was found kinked.No more damages were found in the returned device.Microscopic inspection of the pusherwire was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and it was found detached.The detached part was not returned.Dimensional inspection of the pusher wire that could be measured were performed and were within specifications.Dimensional inspection of the main coil was performed and revealed that the outer diameter (od) of the zap tip and primary coil were within specification.However, there were lacking no.If fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 05may2020.It was reported that there was resistance in pushing the coil and got stuck on the sheath.The target lesion was located in the splenic vein.A 5mmx15cm interlock was selected for use.Upon introduction, resistance was noted upon pushing the coil from its sheath into the imager catheter after flushing.Subsequently, the coil stuck in its sheath and could not be delivered into the catheter.The device was then removed, and the procedure was continued using another device of the same size.No complications reported and the patient is stable.However, device analysis revealed interlocking arm detached and 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: 10087813
• Report Number: 2134265-2020-06983
• Device Sequence Number: 11378870
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: 08714729764984
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 05/26/2020

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: 07/15/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024271202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER- IMAGER CATHETER
• Patient Age: 50 YR
• Patient Weight: 70