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

Model Number	M001361570
Medical Device Problem Codes	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	01/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4: weight: 54.5 kg.E1 - initial reporter phone: (b)(6).Investigation results: device evaluated by mfr: the pe f-idc device was returned for analysis.Visual inspection revealed the main coil was bent and stretched at the primary coil section, also the arm coil was detached.Microscopic inspection revealed the main coil was detached, bent and stretched.Dimensional inspection of the main coil revealed the components were within specification.No other issues were identified during the product analysis.Dhr (device history record) review it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review performed for the pe f-idc device confirmed that the event of main coil unable to advance in catheter, main coil stretched, bent/kinked, stretched and detached/separated are known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to procedure.
Event or Problem Description
Reportable based on device analysis on 27feb2026.It was reported that the coil could not advance in the microcatheter.The patient underwent transcatheter embolization of a splenic aneurysm under local anesthesia.The target lesion was located in the left femoral artery.An stc microcatheter and 18 controllable coils were utilized for embolization.The initial coils, 14 mm x 30 cm, 12 mm x 30 cm, and 10 mm x 30 cm were delivered without difficulty.However, the final 6 mm x 20 cm controllable coil was advanced into the microcatheter and became stuck.Despite repeated attempts, advancement was unsuccessful, and the coil was subsequently withdrawn.Upon inspection, the controllable coil was noted to be stretched.A second 6 mm x 20 cm controllable coil was then selected and delivered using the same stc boston scientific microcatheter.This coil was deployed without difficulty, and the procedure was completed successfully.There were no patient complications reported as a result of this event, and the patient was stable post-procedure.However, device analysis revealed that the coil arm 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: 24741140
• Report Number: 2124215-2026-16897
• Device Sequence Number: 18471122
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: (01)08714729765004(17)270423(10)34094800
• 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): 03/31/2026

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: M001361570
• Device Catalogue Number: M001361570
• Device Lot Number: 0034094800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER: STC
• Patient Age: 58 YR
• Patient Sex: Female