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

Model Number	83786
Medical Device Problem Codes	Entrapment of Device (1212); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A main coil was returned for this complaint.The main coil was found kinked and stretched.No more damages were noticed.The zap tip has a smooth surface.The interlocking arm was inspected, and it was detached, the detached arm part was not returned.Dimensional inspection of the main coil revealed the components were within specification, except the number of distal fiber bundles.There were only 7 out of 17 and the number of proximal fiber bundles were only 10 out of 37-44.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that the coil became stuck in the middle part of the catheter.The target lesion was located in the iliac artery.A 15mm x 40cm interlock-35 was selected for use.During the procedure, the coil could not be pushed forward.Upon withdrawal, it was noted that the coil became stuck in the middle part of the catheter.The coil was withdrawn together with the delivery system, out of the patient, and the procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached and fiber bundles were missing.

• 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
• MDR Report Key: 11759199
• Report Number: 2134265-2021-05533
• Device Sequence Number: 17266197
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 09/30/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026103435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 60