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

Model Number	M001361930
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coil had stretched from the aneurysm to the groin.The target lesion was located in the splenic artery.A 14 mm x 50 cm interlock coil and direxion microcatheter were selected for aneurysm embolization.During the procedure, a non-boston scientific (non-bsc) microcatheter was positioned, and a non-bsc stent was half-deployed.Then, the direxion microcatheter was placed into the aneurysm sac, and coils were deployed without any issues.The non-bsc stent was then deployed.However, it was observed that the coil had stretched from the aneurysm to the groin.Removal of the bern-tip direxion microcatheter proved difficult, possibly because it was jailed within the sac alongside the coils.The physician had to push the coil up into the sac which was very difficult but ultimately successful.The non-bsc stent also had to be pushed into the sac and another stent placed across the wide neck.The coil may not have been advanced far enough for proper deployment, as visualization of the tip was obscured by the coil nest.There were no patient complications as a result of this event, and the procedure was completed.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that a coil had stretched from the aneurysm to the groin.The target lesion was located in the splenic artery.A 14mm x 50cm interlock coil and direxion microcatheter were selected for aneurysm embolization.During the procedure, a non-boston scientific (non-bsc) microcatheter was positioned, and a non-bsc stent was half-deployed.Then, the direxion microcatheter was placed into the aneurysm sac, and coils were deployed without any issues.The non-bsc stent was then deployed.However, it was observed that the coil had stretched from the aneurysm to the groin.Removal of the bern-tip direxion microcatheter proved difficult, possibly because it was jailed within the sac alongside the coils.The physician had to push the coil up into the sac which was very difficult but ultimately successful.The non-bsc stent also had to be pushed into the sac and another stent placed across the wide neck.The coil may not have been advanced far enough for proper deployment, as visualization of the tip was obscured by the coil nest.There were no patient complications as a result of this event, and the procedure was completed.It was further reported that target lesion was moderately tortuous and non-calcified.The coil did not detach and when the pusher wire was removed by pulling it out by force, it brought the coil with it.However, some staying in the aneurysm sac nest and the coil stretched along the catheter to the patient's groin.There was no coil migration occurred.

• 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: 23469809
• Report Number: 2124215-2025-78749
• Device Sequence Number: 9018932
• Product Code: KRD
• UDI-Device Identifier: 08714729845294
• UDI-Public: (01)08714729845294(17)280527(10)36853342
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/25/2025

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: M001361930
• Device Catalogue Number: M001361930
• Device Lot Number: 0036853342
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 06/27/2025
• 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 - REBAR MICROCATHETER; MICROCATHETER - REBAR MICROCATHETER; STENT - SOLITAIRE STENT; STENT - SOLITAIRE STENT
• Patient Age: 79 YR
• Patient Sex: Female