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

Model Number	M001363800
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) university.E1 - initial reporter phone: good faith effort attempts were made to try and retrieve the product return status, but further information was unable to be obtained.
Event or Problem Description
It was reported that the coil became stuck with the catheter tip.The patient presented with a splenic aneurysm and underwent embolization with a 10 mm x 40 cm interlock.035 coil.The coil delivery was performed using a non-boston scientific contrast catheter.However, during deployment, the coil could not be fully advanced in the non-boston scientific contrast catheter.Both the coil and catheter were withdrawn out of the body.Upon inspection, it was noted that the tail end of the coil was stretched and protruding from the catheter's tip.The procedure was completed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.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24911333
• Report Number: 2124215-2026-20894
• Device Sequence Number: 18623974
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: (01)08714729795513(17)280409(10)36272302
• 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): 05/21/2026

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0036272302
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 04/10/2025
• 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: CONTRAST CATHETER - CORDIS 5F
• Patient Age: 61 YR
• Patient Sex: Female