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

Model Number	M001363670
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 22jul2025.It was reported that the coil was stuck and could not move forward.A 18mm x 40cm interlock-35 coil was advanced to embolize the abdominal aortic aneurysm.During delivery of the coil through the catheter, the coil could not move forward.It was then withdrawn, and was delivered again; but the coil was still stuck at the orifice of the catheter and could not move forward.The whole set was removed, and replaced it with a new 18mm x 40cm interlock-35 coil.The procedure was completed and there was no patient complications noted as a result of this event.The patient condition following procedure was stable.However, returned device analysis revealed the coil arm was detached.
Additional Manufacturer Narrative
Device evaluated by manufacturer: media inspection was performed and it showed the box of the device which matches with the provided upn by the customer.Visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery wire were returned.The main coil was bent and stretched, and the coil arm was detached from the main coil.Dimensional inspection of the main coil's zap tip outer diameter (od) and primary coil od passed the specification test.Moreover, the delivery wire's max wield od, max wire and max wire arm od also passed the specification test.
Event or Problem Description
Reportable based on device analysis completed on 22jul2025.It was reported that the coil was stuck and could not move forward.A 18mm x 40cm interlock-35 coil was advanced to embolize the abdominal aortic aneurysm.During delivery of the coil through the catheter, the coil could not move forward.It was then withdrawn, and was delivered again; but the coil was still stuck at the orifice of the catheter and could not move forward.The whole set was removed and replaced it with a new 18mm x 40cm interlock-35 coil.The procedure was completed and there was no patient complications noted as a result of this event.The patient condition following procedure was stable.However, returned device analysis revealed the coil arm was detached.
Additional Manufacturer Narrative
Device evaluated by manufacturer: media inspection was performed and it showed the box of the device which matches with the provided upn by the customer.Visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery wire were returned.The main coil was bent and stretched, and the coil arm was detached from the main coil.Dimensional inspection of the main coil's zap tip outer diameter (od) and primary coil od passed the specification test.Moreover, the delivery wire's max wield od, max wire and max wire arm od also passed the specification test.

• 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: 22816656
• Report Number: 2124215-2025-52177
• Device Sequence Number: 15642588
• Product Code: KRD
• UDI-Device Identifier: 08714729795414
• UDI-Public: (01)08714729795414(17)270608(10)34198235
• 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,Followup
• Report Date (Section B): 02/05/2026

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: M001363670
• Device Catalogue Number: M001363670
• Device Lot Number: 0034198235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG