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

Model Number	M001363550
Medical Device Problem Codes	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	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil unraveled, requiring intervention.A 6mm x 20cm interlock?-35 was selected for use in an arteriovenous malformation (avm) embolization procedure.During the procedure, it was noted that the coil unraveled during deployment and had to be snared out of the body to remove it.The procedure was completed, and there were no patient complications as a result of this event.
Event or Problem Description
It was reported that the coil unraveled, requiring intervention.A 6mm x 20cm interlock?-35 was selected for use in an arteriovenous malformation (avm) embolization procedure.During the procedure, it was noted that the coil unraveled during deployment and had to be snared out of the body to remove it.The procedure was completed, and there were no patient complications as a result of this event.It was further reported that the coil was not stuck within the non-boston scientific catheter.The coil was removed completely from the body with the snare device.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis it was observed that only the main coil was returned.It was observed that the main coil was bent and stretched at the primary coil section, moreover the arm coil was detached.A media was attached in the parent record, it was possible to observed that the main coil was bent and stretched.

• 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: 23699962
• Report Number: 2124215-2025-86330
• Device Sequence Number: 16000565
• Product Code: KRD
• UDI-Device Identifier: 08714729793021
• UDI-Public: (01)08714729793021(17)270522(10)34090161
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: M001363550
• Device Catalogue Number: M001363550
• Device Lot Number: 0034090161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown