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

Model Number	M001361940
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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.It was noted that the main coil, introducer sheath, and pusher wire were submitted for analysis.Visual inspection revealed that the main coil was bent and stretched in both the coil arm and primary coil sections.Additionally, the arm coil was found to be detached.The pusher wire exhibited kinking at the heat shrink tfe tubing and coil section.The mid solder joint was also detached.Furthermore, the main coil was observed to be detached, in addition to being bent and stretched.The pusher wire was also detached.A photograph was referenced in the parent record; however, it does not clearly depict the reported issue or the specific device in question.
Event or Problem Description
Reportable based on the device analysis completed on24apr2025.It was reported that the coil could not be pushed forward.The stenosed target lesion was located in the renal artery.A 18mm x 50cm interlock device was selected for use.During the procedure, after the coil protective sheath was inserted into the y valve, it could only be retracted but not advanced.Attempts to advance the sheath following repeated hydrophilic coating activation were unsuccessful.The procedure was subsequently completed using another device of the same type.There were no patient complications as a result of this event.However, device analysis revealed that the arm coil was detached.

• Brand Name: INTERLOCK?
• 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: 22056553
• Report Number: 2124215-2025-31436
• Device Sequence Number: 14495877
• Product Code: KRD
• UDI-Device Identifier: 08714729845300
• UDI-Public: (01)08714729845300(17)260508(10)31778562
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 05/20/2025

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 Expiration Date: 05/08/2026
• Device Model Number: M001361940
• Device Catalogue Number: M001361940
• Device Lot Number: 0031778562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 64 KG