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	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, pusher wire, and introducer sheath were returned for this complaint.The pusher wire and coil were interlock inside the introducer sheath.The twist lock of the introducer sheath was found opened.The introducer sheath was inspected and no anomalies was noted.The pusher wire was inspected kinked.The coil was inspected and it was kinked/ stretched.The main coil was advanced through the introducer sheath without problems, no resistance was felt.Microscopic inspection of the pusher wire was performed and revealed that the proximal end has a smooth surface.The interlocking arm was inspected and it was kinked.Microscopic inspection of the main coil was performed and revealed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies was noted.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 specifications.However, there were missing number of fiber bundles due to coil stretched.
Event or Problem Description
Reportable based on device analysis completed on 22oct2020.It was reported that coil stuck in the middle of microcatheter.The target lesion was located in the internal iliac artery.A 12mmx20cm interlock was selected for use.During procedure, a heparin saline drip was applied upon placing a renegade microcatheter.The 12mmx20cm coil was then delivered but could not be pushed after advancing in the middle of the catheter after several attempts.Subsequently, the coil was simply pulled out from the patient's body.A 10cmx20cm coil was then replaced and completed the procedure.There were no complications reported and patient was stable.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: 10810156
• Report Number: 2134265-2020-15499
• Device Sequence Number: 14497442
• Product Code: KRD
• UDI-Device Identifier: 08714729765042
• UDI-Public: 08714729765042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/09/2020

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: 11/10/2022
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0024912533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/09/2020
• 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: MICROCATHETER- RENEGADE STC 18
• Patient Age: 67 YR
• Patient Weight: 68