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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil protruded from catheter tip upon removal.The target lesion area was located in the moderately tortuous internal iliac artery.A 10mmx50cm interlock was selected for use.During the procedure, it was noted that the coil got stuck inside the distal part of the catheter.The coil and catheter were removed together.Subsequently, the coil protruded from catheter's tip upon removal.The procedure was completed without replacing the device.There were no patient complications reported.
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 coil returned outside the introducer sheath.The twist lock of the introducer sheath had been opened.The coil was inspected, and it was found kinked and stretched.The pusher wire was found kinked.No more damages were found in the returned device.Microscopic inspection of the pusher wire was performed and observed that the zap tip 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 pusher wire and main coil that could be measured were performed and were within specifications.
Event or Problem Description
It was reported that the coil protruded from catheter tip upon removal.The target lesion area was located in the moderately tortuous internal iliac artery.A 10mmx50cm interlock was selected for use.During the procedure, it was noted that the coil got stuck inside the distal part of the catheter.The coil and catheter were removed together.Subsequently, the coil protruded from catheter's tip upon removal.The procedure was completed without replacing the device.There were no patient complications reported.

• 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: 11732521
• Report Number: 2134265-2021-05164
• Device Sequence Number: 14559668
• Product Code: KRD
• UDI-Device Identifier: 08714729845287
• UDI-Public: 08714729845287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 08/16/2023
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026021642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 05/27/2021
• 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: INTRODUCER SHEATH-6FR TERUMO; INTRODUCER SHEATH-6FR TERUMO; MICRO CATHETER-HI-LEX CORPORATION COILING SUPPORT; MICRO CATHETER-HI-LEX CORPORATION COILING SUPPORT; INTRODUCER SHEATH-6FR TERUMO; MICRO CATHETER-HI-LEX CORPORATION COILING SUPPORT