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

Model Number	83786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on additional information received on (b)(6) 2022.It was reported that coil frayed.The target lesion was located in the pelvic varicose veins.A 15mm x 40cm interlock.035 was selected for use.During the procedure, it was noted that the coil is passed through a 5 fr catheter and frayed.It was further confirmed that the device was damaged and disintegrated.The coil is withdrawn through the catheter without problem and the procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The main coil, the delivery wire and the introducer sheath were returned for this complaint.The main coil and the delivery wire were not interlocked.Twist lock was opened.The main coil stretched, and the interlocking arm was detached.No more damages were observed.The functional test could not be performed due the returned condition of the device.Microscope inspection revealed that under microscope it was observed that the main coil was detached at interlocking arm section.Dimensional inspection of the delivery wire revealed that the overall dimensions (od) of the weld, wire arm and wire were within the specification.For the main coil, the zap tip (od) and the primary coil (od) were within the specification.Coil arm od could not be measured due it was detached.
Event or Problem Description
Reportable based on additional information received on 04nov2022.It was reported that coil frayed.The target lesion was located in the pelvic varicose veins.A 15mm x 40cm interlock.035 was selected for use.During the procedure, it was noted that the coil is passed through a 5 fr catheter and frayed.It was further confirmed that the device was damaged and disintegrated.The coil is withdrawn through the catheter without problem and the procedure was completed with another of the same device.No patient complications reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15890477
• Report Number: 2124215-2022-46638
• Device Sequence Number: 20505521
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 07/27/2025
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0029846351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female