MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	83787
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that only main coil was returned for this complaint.The introducer sheath and delivery wire were not returned.The coil was inspected, and it was found kinked and stretched.No more damages were noticed.Microscopic inspection of the coil observed that the zap tip has a smooth surface.The interlocking arm was detached.Dimensional inspection of the coil that could be measured were performed and were within specification.
Event or Problem Description
Reportable based on device analysis completed on 05jan2022.It was reported that the coil stuck inside the catheter.The target lesion was located in the moderately tortuous internal iliac artery.A 6mm x 20cm interlock-35 was selected for use.During the procedure, it was noted that the coil got stuck in the distal part of the catheter and were removed together.The procedure was completed with anther of the same device.No patient complications reported.However, device analysis revealed that the interlocking arm was detached.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13389297
• Report Number: 2134265-2022-00575
• Device Sequence Number: 4935834
• Product Code: KRD
• UDI-Device Identifier: 08714729793090
• UDI-Public: 08714729793090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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: 12/08/2023
• Device Model Number: 83787
• Device Catalogue Number: 83787
• Device Lot Number: 0026481642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2020
• 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: TEMPO4 VER- GUIDE CATHETER
• Patient Sex: Unknown