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

Model Number	83786
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A valve, delivery wire, main coil and introducer sheath were returned for this complaint.The coil and delivery wire arms were not interlocked.The introducer sheath was inspected, a and no anomalies were noticed, the twist lock had been opened.The delivery wire was in good condition, no damages were found.The main coil was found stretched and kinked and it was exiting at the distal end of the introducer sheath.Blood was noticed on the fiber blundes.The interlocking arm of the coil was detached.No more damages were found on the device.The main coil exit from the introducer sheath without problems, no resistance was felt.Microscopic inspection of the delivery wire observed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noted.Microscopic inspection of the main coil observed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was found detached, part was not returned.Dimensional inspection of the delivery wire and main coil that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 25aug2021.It was reported that the coil failed to deploy.An 18mm x 40cm interlock-35 was selected for use.During the procedure, it was noted that coil failed to deploy.The procedure was completed with another of the same device.There was no complications reported and patient was stable post procedure.However, device analysis revealed interlocking arm detached.

• 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: 12481336
• Report Number: 2134265-2021-11655
• Device Sequence Number: 3812175
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 12/01/2023
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0026442952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 73