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	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: only the main coil was returned for analysis.The coil was returned stuck inside a cordis microcatheter.The catheter was cut and the coil was removed from the catheter.The coil was found to be kinked and stretched.Microscopic inspection revealed that the zap tip of the main coil has a smooth surface.The interlocking arm was inspected, and the interlocking arm was found detached.Dimensional inspection revealed that the number of distal fiber bundles, the overall dimension (od) of zap tip and primary coil (od) are within specification, while the number of proximal fiber bundles did not match with specification as there was loss of fiber bundles.
Event or Problem Description
Reportable based on device analysis completed on 11feb2021.It was reported that the coil could not advance through the microcatheter.A 2d 18mm x 40cm interlock-35 embolics was selected for use in an embolization of the spleenic artery.During the procedure, resistance was felt upon advancement on the coil.Subsequently, it was noted that the device could not be pushed and was stuck at the middle of the catheter.The device was pulled out, and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.However, device analysis revealed a detached interlocking arm and loss of proximal 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: 11385715
• Report Number: 2134265-2021-02489
• Device Sequence Number: 19693898
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: 08714729795414
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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: 10/09/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024574413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/26/2021
• 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: 60