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

Model Number	83786
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: visual inspection was performed, and it was observed that the main coil was bent and stretched at the coil arm and primary coil section.Additionally, the coil arm was detached.Microscopic inspection revealed the main coil was bent, stretched, and detached.The main coil and the pusher wire were not interlocking, and functional inspection was unable to be performed as a result.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2024.An 8mm x 40cm 2d interlock-35 coil was selected for use in the embolization procedure.During the procedure, the physician was unable to advance the coil through an unknown 5f catheter.The interlock-35 was removed, and another of the same device was used to complete the procedure.No patient complications were reported.However, returned 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: 20206820
• Report Number: 2124215-2024-56173
• Device Sequence Number: 7643765
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: 08714729793014
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: 09/20/2026
• Device Model Number: 83786
• Device Catalogue Number: 83786
• Device Lot Number: 0032472113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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
• Patient Sex: Unknown