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); Premature Activation (1484); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.A 8mm x 40cm interlock coil and a 10mm x 20cm interlock coil were selected for use.During procedure, it was noted that there was resistance felt during deployment of the coil, and it could not be pushed further.The pusher wire was pulled out, but coil was left detached inside the 5f non boston scientific catheter.The same event occurred with the second coil.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the delivery wire was returned inside the introducer sheath.The main coil returned out of the introducer sheath, it was found damaged, kinked and stretched.The main coil was found without fiber bundles.The zap tip and the interlocking arm were detached, the parts were not returned.The twist lock of the introducer sheath had been opened.The delivery wire was inspected, and no anomalies were noted.The delivery wire was advanced through the introducer sheath, without problems, no resistance was noticed.The proximal end has a smooth surface.The interlocking arm was inspected, and no damages were found.The delivery wire proximal end has a smooth surface.The interlocking arm was inspected, and no damages were found.The main coil interlocking arm and zap tip were detached.The parts were not returned.Dimensional inspection of the distal and proximal fiber bundles revealed the number of fiber bundles were below specification.
Event or Problem Description
It was reported that the coil protruded from the catheter's tip during removal.A 8mm x 40cm interlock coil and a 10mm x 20cm interlock coil were selected for use.During procedure, it was noted that there was resistance felt during deployment of the coil, and it could not be pushed further.The pusher wire was pulled out, but coil was left detached inside the 5f non boston scientific catheter.The same event occurred with the second coil.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.

• 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: 11800967
• Report Number: 2134265-2021-06074
• Device Sequence Number: 14443578
• Product Code: KRD
• UDI-Device Identifier: 08714729793137
• UDI-Public: 08714729793137
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 05/24/2021

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: 08/14/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024271145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1