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

Model Number	83779
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.The target lesion was located in the internal iliac artery.A 6mm x 20cm interlock coil was selected for endovascular aneurysm repair (evar).During the procedure, it was noted that the coil had separated when it was advanced through the catheter and attempted to be taken out.The entire catheter was removed, and the procedure was completed with another of the same device.No patient injury reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil, the introducer sheath and the pusher wire were returned for analysis.Visual inspection was performed, and no damage was observed in the main coil.A part of the original box was returned, and it was observed that the pouch information matches with the complaint information.The functional could not be performed due to the main coil and the pusher wire are not interlocking.Dimensional inspection of the main coil revealed that the components were within specifications.Based on analysis of the returned product, the reported allegations could not be confirmed, since no damages were found on the device.
Event or Problem Description
It was reported that a catheter break occurred.The target lesion was located in the internal iliac artery.A 6mm x 20cm interlock coil was selected for endovascular aneurysm repair (evar).During the procedure, it was noticed that the coil had separated when it was advanced through the catheter and attempted to be taken out.The entire catheter was removed, and the procedure was completed with another of the same device.No patient injury reported.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19778234
• Report Number: 2124215-2024-44553
• Device Sequence Number: 8654816
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: 08714729765004
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 08/14/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032423393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER - BREAKTHROUGH 2M; MICRO CATHETER - BREAKTHROUGH 2M
• Patient Sex: Unknown