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

Model Number	M001363820
Medical Device Problem Codes	Premature Activation (1484); 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	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the interlock was returned for analysis.Upon examination, it was noted that the main coil was bent, stretched, and detached at the coil arm section.
Event or Problem Description
Reportable based on device analysis completed on 26jun2025.It was reported that coil unable to advance occurred.The target lesion was located in the severe tortuous and non calcified splenic artery.A 15mm x 40cm.035 interlock cube was used for procedure.Prior to the procedure, it was confirmed that the product interlocking arm was securely locked.However, the coil could not be advanced out of the catheter, which caused it to become unhooked inside the catheter.The procedure was successfully completed using another device of the same type.There were no patient complications as a result of this event.However, returned device analysis revealed a 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: 22589012
• Report Number: 2124215-2025-49757
• Device Sequence Number: 9190618
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: (01)08714729795438(17)270404(10)33756929
• 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): 07/24/2025

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: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0033756929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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: 64 YR
• Patient Sex: Male