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

Model Number	M001363650
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); 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	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).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 totally stretched and bent; additionally, the coil arm was detached.Dimensional inspection of the main coil revealed the components were within specifications.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that the coil became stretched and could not be advanced nor withdrawn from the catheter.A 15mm x 40cm interlock.035 coil was selected for use in an iliac aneurysm for an abdominal aortic dissection repair.However, during the delivery, the coil was stretched halfway and could not be further advanced.Attempts to retract it into the delivery sheath were unsuccessful, necessitating the withdrawal of the entire delivery system.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a detached coil arm.
Additional Manufacturer Narrative
A1 - patient identifier: updated.E1 - initial reporter phone: (b)(6).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 totally stretched and bent; additionally, the coil arm was detached.Dimensional inspection of the main coil revealed the components were within specifications.
Event or Problem Description
Reportable based on device analysis completed on 25sep2025.It was reported that the coil became stretched and could not be advanced nor withdrawn from the catheter.A 15mm x 40cm interlock.035 coil was selected for use in an iliac aneurysm for an abdominal aortic dissection repair.However, during the delivery, the coil was stretched halfway and could not be further advanced.Attempts to retract it into the delivery sheath were unsuccessful, necessitating the withdrawal of the entire delivery system.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed a detached coil arm.

• 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: 23358022
• Report Number: 2124215-2025-74478
• Device Sequence Number: 9091038
• Product Code: KRD
• UDI-Device Identifier: 08714729793144
• UDI-Public: (01)08714729793144(17)271024(10)35136963
• 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: M001363650
• Device Catalogue Number: M001363650
• Device Lot Number: 0035136963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG