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

Model Number	83786
Medical Device Problem Codes	Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned for analysis.The coil was inspected and it was found kinked and stretched.Microscopic inspection was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected and no anomalies were noted.Dimensional inspection of the main coil that could be measured was performed and observed that the outer diameter (od) of the zap tip and primary coil were within specifications.The number of distal and proximal fiber bundles were found to be missing and below specification.
Event or Problem Description
Reportable based on device analysis completed on 01feb2021.It was reported that the coil could not advance and deploy.The target lesion was located in the abdominal aortic artery.A 15mmx40cm interlock-35 was selected for use.During procedure, it was noted that the coil could not be advanced and deploy in the area.The coil was removed and the procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the device had missing fiber bundles.

• 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: 11382247
• Report Number: 2134265-2021-02442
• Device Sequence Number: 3443493
• 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): 02/25/2021

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: 06/05/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0023911176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 76