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

Model Number	M001363630
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that vascular spasm noted during re-selection attempted resulting in procedure cancelled.Patient was presented with pelvic congestion syndrome.A 12mm x 40cm interlock -35 was selected for use in an embolization.During the procedure, the initial coil configuration was unsatisfactory.During retrieval for re-deployment, the coil became stuck, requiring withdrawal of the entire system.While preparing for a new coil, the non-boston scientific guide catheter dislodged from the left renal vein, and attempts to re-select were complicated by vascular spasm, leading to termination of the procedure.There were no patient complication as the result of this event.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that vascular spasm noted during re-selection attempted resulting in procedure cancelled.Patient was presented with pelvic congestion syndrome.A 12mm x 40cm interlock -35 was selected for use in an embolization.During the procedure, the initial coil configuration was unsatisfactory.During retrieval for re-deployment, the coil became stuck, requiring withdrawal of the entire system.While preparing for a new coil, the non-boston scientific guide catheter dislodged from the left renal vein, and attempts to re-select were complicated by vascular spasm, leading to termination of the procedure.There were no patient complication as the result of this event.It was further reported that the patient was under local anesthesia.The procedure was paused to relieve the vasospasm.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1 - initial reporter address 1:(b)(6).E1 - initial reporter phone: (b)(4).

• 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: 23864810
• Report Number: 2124215-2025-92299
• Device Sequence Number: 20169490
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: (01)08714729792970(17)271223(10)35534851
• 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): 01/20/2026

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: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0035534851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 61 KG