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

Model Number	M001361550
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601); 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	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: date of birth: 1979.E1: initial reporter phone: (b)(6).Device evaluated by mfr: the pe f-idc was returned for analysis.It was observed that only the main coil was returned.It was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.
Event or Problem Description
Reportable based on device analysis completed on 19nov2025.It was reported that unable to advance in catheter and stretched occurred.The patient underwent pelvic endovenous isolation embolization located in the ovarian vein.A 5mm x 15cm pe f-idc was selected for use.During the procedure, when the third interlock was used to push forward, it was noted that the coil could not be pushed and deployed at the end of the bsc microcatheter.Several attempts failed, and when the coil was pulled back, the coil was stretched due to great resistance.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed an arm coil 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: 23810176
• Report Number: 2124215-2025-90939
• Device Sequence Number: 21156517
• Product Code: KRD
• UDI-Device Identifier: 08714729764984
• UDI-Public: (01)08714729764984(17)270729(10)34732980
• 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): 12/15/2025

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: M001361550
• Device Catalogue Number: M001361550
• Device Lot Number: 0034732980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 59 KG