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

Model Number	83786
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device investigations completed on 18may2022.It was reported that advancing failure occurred.The 50% stenosed target lesion was located in the moderately tortuous and mildly calcified internal iliac artery.A 12mm x 20cm interlock-35 embolics was selected for use.During the procedure, it was noted that the coil could not be advanced from the introducer and was hard, the coil did not come out due to the stack.The procedure was completed with another of the same device.There were no complications reported.However, device analysis confirmed that the coil was broken near the interlocking arm and fiber loss was noted.It was also further confirmed that no fiber residue left inside the patient.
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 delivery wire arms were interlocked inside the introducer sheath.Blood was noticed inside the introducer sheath.The twist lock of the introducer sheath had been opened.The introducer sheath was observed, and no damages were observed.The delivery wire was inspected, and no anomalies were noted.The coil was inspected, and it was found kinked and stretched.No more damages were found.Functional inspection revealed that the delivery wire was advanced through the introducer sheath, but it was not possible to continue advancing it because the coil was stuck, it was pulled out backwards in order to release the main coil.Microscopic inspection revealed that the zap tip of the delivery wire has a smooth surface and the interlocking arm was inspected, and no anomalies were noted.The zap tip of the main coil has a smooth surface.The interlocking arm was inspected, and no anomalies were noted and the main coil was broken near the interlocking arm.Dimensional inspection revealed that the overall dimension (od) of the delivery wire were within the specifications.The main coil, zap tip, and primary coil were within specifications.However, the number of proximal fiber bundles did not match specification.Fiber loss due the coil stretching condition.

• 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: 14633331
• Report Number: 2134265-2022-06278
• Device Sequence Number: 12241683
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• 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): 06/08/2022

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: 10/20/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026218780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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
• Patient Sex: Unknown