MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M001363590
Medical Device Problem Codes	Premature Activation (1484); Device-Device Incompatibility (2919); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil penetrated the guide catheter and then detached early, requiring intervention.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified iia inferior gluteal artery.A 8mm x 40cm interlock-35 coil was selected for abdominal aneurysm treatment.During the coil delivery, the coil penetrated the 5f non-boston scientific guide catheter and then detached.The coil was temporarily left inside the body and later recovered using a snare.The procedure was completed with a different device.There was no patient complications noted as a result of this event.
Additional Manufacturer Narrative
E1 initial address 1: (b)(6).
Additional Manufacturer Narrative
E1 initial address 1: (b)(6).Device evaluation by manufacturer: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery wire were returned.The main coil was bent and stretched at the primary coil section.Dimensional inspection was performed, and the main coil's zap tip outer diameter (od), primary coil od and max coil arm od passed the specification test.
Event or Problem Description
It was reported that the coil penetrated the guide catheter and then detached early, requiring intervention.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified iia inferior gluteal artery.A 8mm x 40cm interlock-35 coil was selected for abdominal aneurysm treatment.During the coil delivery, the coil penetrated the 5f non-boston scientific guide catheter and then detached.The coil was temporarily left inside the body and later recovered using a snare.The procedure was completed with a different device.There was no patient complications noted as a result of this event.It was further reported that vascular access was obtained via the groin with no tortuosity at the puncture site.During device delivery, resistance was encountered.Moreover, there was no indication that the device malfunctioned or broke prior to penetrating the catheter.

• Brand Name: INTERLOCK-35
• 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: 22199083
• Report Number: 2124215-2025-35711
• Device Sequence Number: 7722877
• Product Code: KRD
• UDI-Device Identifier: 08714729793014
• UDI-Public: (01)08714729793014(17)271007(10)35009857
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133208
• 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): 07/14/2025

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: M001363590
• Device Catalogue Number: M001363590
• Device Lot Number: 0035009857
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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: GUIDE CATHETER: IMPRESS 5F BERENSTEIN; GUIDE CATHETER: IMPRESS 5F BERENSTEIN; GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: GOA 12F DRYSEAL; INTRODUCER SHEATH: GOA 12F DRYSEAL
• Patient Sex: Unknown