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

Model Number	M001361570
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil unraveled in the body, requiring intervention.A 6mm x 20cm interlock coil was advanced for endovascular aneurysm repair procedure of the inferior mesenteric artery.When attempting to retrieve the coil that was intended to be placed, a resistance was encountered, and the coil became damaged; it unraveled in the body.There was no detachment noted.The coil was attempted to be removed along the with the catheter; however, it was then retrieved using a snare.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's condition was good.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was returned for analysis.Visual and microscopic inspection observed that only the main coil was returned.It was bent and stretched and detached at the coil arm section.The pouch information matches with the complaint information.Dimensional inspection was performed, and the main coil's arm outer diameter (od), max zap tip od and primary coil od passed the specification test.Additionally, the pusher wire's distal solder joint od, mid solder joint, distal and proximal tfe od also passed the specification test.
Event or Problem Description
It was reported that the coil unraveled in the body, requiring intervention.A 6mm x 20cm interlock coil was advanced for endovascular aneurysm repair procedure of the inferior mesenteric artery.When attempting to retrieve the coil that was intended to be placed, a resistance was encountered, and the coil became damaged; it unraveled in the body.There was no detachment noted.The coil was attempted to be removed along the with the catheter; however, it was then retrieved using a snare.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's condition was good.

• 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: 22341839
• Report Number: 2124215-2025-40019
• Device Sequence Number: 15720641
• Product Code: KRD
• UDI-Device Identifier: 08714729765004
• UDI-Public: (01)08714729765004(17)261229(10)33312049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/14/2025

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: M001361570
• Device Catalogue Number: M001361570
• Device Lot Number: 0033312049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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: BREAKTHROUGH.; MICROCATHETER: BREAKTHROUGH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown