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

Model Number	M001363830
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Separation Failure (2547); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil became fractured.The non-stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 20mm x 40cm interlock.035 coil was selected for pelvic variceal embolization.During the procedure, resistance was noted while the coil was delivered using a non-boston scientific catheter.Although the coil was successfully advanced to the target vessel, it failed to release.Upon withdrawal, the coil was released halfway through the catheter's path and fractured at its mid segment.As a result, the catheter was removed with the coil inside and the procedure was completed with another interlock coil and a new catheter.There were no patient complications as a result of this event.

• 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: 22993668
• Report Number: 2124215-2025-59216
• Device Sequence Number: 8806531
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: (01)08714729795445(17)280512(10)36505091
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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 Model Number: M001363830
• Device Catalogue Number: M001363830
• Device Lot Number: 0036505091
• 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: 08/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 05/13/2025
• 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: CATHETER - CATHETER IMPRESS MPA1, 0.038, 5FR.
• Patient Sex: Unknown