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	11/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Only a delivery wire and main coil were returned for this complaint.No damages were found in the delivery wire.The main coil was found kinked and stretched.Microscopic inspection of the main coil was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and it was detached, the detached arm part was not returned.Microscopic inspection of the delivery wire was performed and observed that the zap tip has a smooth surface.The interlocking arm was inspected, and no anomalies was noticed.Dimensional inspection of the coil and delivery wire that could be measured were performed and were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 05apr2021.It was reported that the coil failed to pass, stuck, and prematurely detached.The target lesion was located in the internal iliac artery.A 15mm x 40cm interlock-35 was selected for use.During procedure, it was noted that the coil failed to pass the middle part of the catheter and was stuck.Subsequently, the advancing wire was noted to be detached from the coil.Both coil and catheter were then removed.The procedure was completed with another of same device.No complications reported and patient was stable post procedure.However, device analysis revealed that the interlocking arm was detached and not returned.

• 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: 11745533
• Report Number: 2134265-2021-05460
• Device Sequence Number: 4318929
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: 08714729793144
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 04/29/2021

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: 08/07/2022
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0024233867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER- 5FR COBRA; GUIDEWIRE- 0.035 GW
• Patient Age: 35 YR
• Patient Weight: 55