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

Model Number	M001361510
Medical Device Problem Codes	Break (1069); Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a coil break occurred, requiring additional intervention.The non-stenosed target lesion was located in the mildly tortuous and non-calcified splenic artery.A 3 mm x 12 cm interlock coil was selected for a splenic artery embolization procedure.During the procedure, after reaching the target lesion, coil detachment was attempted.However, the coil did not detach properly.Unraveling occurred while moving not only the delivery wire but also the entire catheter back and forth.Attempts were made to retrieve the coil using a non-boston scientific 2tip straight microcatheter and a snare, but retrieval was unsuccessful.Upon retrieval, fluoroscopic imaging of the abdominal aorta confirmed separation of the interlocking arm on the delivery wire side, which remained within the abdominal aorta.The procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device history record: 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.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 25876917
• Report Number: 2124215-2026-38789
• Device Sequence Number: 8057781
• Product Code: KRD
• UDI-Device Identifier: 08714729764946
• UDI-Public: (01)08714729764946(17)290317(10)39112033
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001361510
• Device Catalogue Number: M001361510
• Device Lot Number: 0039112033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 07/20/2026
• Date Device Manufactured: 04/17/2026
• 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: GUIDE CATHETER - IMAGING CATHETER 4FRGPS.; INTRODUCER SHEATH - 5F 10CM.; MICRO CATHETER - EXCELSIOR 2TIP STRAIGHT.; MICRO CATHETER - XTREME T3 HI-LEX.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown