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

Model Number	M001363550
Medical Device Problem Codes	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	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the main coil, the rhv, the introducer sheath and the delivery wire were returned.Visual and microscope inspections were performed.It was observed that the main coil was bent and stretched at the coil arm and primary coil section, arm coil was detached.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified with the device.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because some of the specific product details are unknown, we are unable to provide some of the specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
Reportable based on device analysis completed on 19may2025.It was reported that coil became stuck in the middle part of the catheter.The 95% stenosed target lesion was located in the severely tortuous and mildly calcified left internal iliac artery.A 6mm x 20cm interlock?-35 was selected for use.During the procedure, it was noted that the coil became stuck in the middle part of the catheter.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed 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 ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22206377
• Report Number: 2124215-2025-36617
• Device Sequence Number: 20761782
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: (01)08714729793021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/13/2025

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: M001363550
• Device Catalogue Number: M001363550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MICORCATHETER: MEDIKIT SHEWARD HOOK 4FR 75CM
• Patient Sex: Unknown