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

Model Number	M001363620
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil was returned for analysis.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the coil arm section.The coil arm was detached.Functional testing could not be performed since the main coil and the delivery wire were not interlocking.Dimensional inspection of the main coil revealed the components were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 14feb2025.It was reported that the coil was deployed outside the catheter and approximately half of the coil was stretched and unraveled.A 12mm x 20cm interlock-35 coil was selected for embolization of an aneurysm in the right internal iliac artery.The anatomy was non-tortuous.During the procedure, the coil was advanced, and some of the coil was deployed outside the non-boston scientific catheter and in the space needed.Approximately half of the coil was stretched and unraveled all the way to the proximal end of the catheter.Attempts to retract the coil were unsuccessful.Attempts to push the coil out with a wire or saline flush were also unsuccessful.The catheter was cut and separated, and the coil was safely removed from the body, and the deployment catheter was removed.A new catheter was placed into the internal iliac, and the procedure was completed with two more coils.There were no patient complications as a result of this event, and the patient was stable for the entire procedure.However, device analysis revealed the coil arm was detached.

• Brand Name: INTERLOCK-35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21607420
• Report Number: 2124215-2025-14419
• Device Sequence Number: 9217277
• Product Code: KRD
• UDI-Device Identifier: 08714729793175
• UDI-Public: 08714729793175
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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 Model Number: M001363620
• Device Catalogue Number: M001363620
• Device Lot Number: 0034094932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER - COOK KUMPE CATHETER
• Patient Sex: Male
• Patient Race: White