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

Model Number	M001363830
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: only 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.It was observed that the zap tip and the coil arm were detached.Functional testing could not be performed since only the main coil was returned.Dimensional inspection of the main coil revealed the returned components were within specification.
Event or Problem Description
Reportable based on device analysis completed on 14feb2025.It was reported that the coil could not be advanced nor withdrawn.A 20mm x 40cm interlock-35 coil was selected for embolization of an aortic dissection.During the procedure, a 5f non-boston scientific catheter was used to deliver the coil into the target location.Because the blood vessel was too twisted, the coil could not move forward.The physician repeatedly pushed it without success, yet the coil could not be advanced even with heparin saline.The coil could not be withdrawn either.Finally, the catheter was withdrawn from the vessel together with the coil.After the coil was withdrawn from the catheter, it was noted that the coil was stretched.The procedure was completed with a different device.There were no patient complications as a result of this event.The patient's condition following the procedure was stable.However, device analysis revealed the zap tip and the coil arm were 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: 21606594
• Report Number: 2124215-2025-14420
• Device Sequence Number: 15642741
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• 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: M001363830
• Device Catalogue Number: M001363830
• Device Lot Number: 0033891349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• 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: 04/24/2024
• 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
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 75 KG