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

Model Number	M001363820
Medical Device Problem Codes	Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 26sep2025.It was reported that device failure to separate occurred.The target lesion was located in the abdominal aorta.A 15mm x 40cm interlock.035 was selected for use.During the procedure, it was noted that the coil could not be deployed in the delivery system, and the controllable coil was withdrawn outside the body.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a detached arm coil.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: the interlock.035 was returned for analysis.It was observed that the main coil, the introducer sheath and the delivery wire were returned.It was observed that the main coil was bent, stretched and detached at the coil arm section.

• 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: 23371163
• Report Number: 2124215-2025-75554
• Device Sequence Number: 15974811
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)260522(10)31674190
• 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): 10/23/2025

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 Expiration Date: 05/22/2026
• Device Model Number: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0031674190
• 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: 09/26/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG