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

Model Number	M001363590
Medical Device Problem Codes	Nonstandard Device (1420); 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	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: no.(b)(6) e1: initial reporter phone: (b)(6).Device evaluated by mfr: the.035 interlock 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 and stretched at the primary coil section, moreover the arm coil was detached.Dimensional inspection of the main coil revealed the zap tip od and primary coil od were within specification.
Event or Problem Description
Reportable based on device analysis completed on 08nov2025.It was reported that device unable to advance and was damaged occurred.The target lesion was located in the abdominal aortic.An 8mm x 40cm.035 interlock was selected for use.The blood vessels were relatively tortuous.During the procedure, when the second 8 x 40 coil was almost completely delivered out of the non- boston scientific angiography catheter tip, resistance occurred and flushing was ineffective.Upon withdrawal, it was observed that the interlocking arm of the coil was damaged and 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, returned device analysis revealed an arm coil 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: 23727737
• Report Number: 2124215-2025-87019
• Device Sequence Number: 13356033
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)260522(10)31673658
• 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): 12/05/2025

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: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0031673658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2025
• Initial Report FDA Received Date: 12/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DELIVERY CATHETER: CORDIS 5F
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG