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

Model Number	M001363800
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil was stretched, requiring intervention.A 10mm x 40cm interlock.035 coil was selected for use.During the procedure, the coil was stretched.A snare was used to remove the coil from the patient's body.The procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Good faith effort attempt was made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that the coil was stretched, requiring intervention.A 10mm x 40cm interlock.035 coil was selected for use.During the procedure, the coil was stretched.A snare was used to remove the coil from the patient's body.There were no patient complications as a result of this event.It was further reported that the target lesion was located in the hepatic vessel.A part of the coil was removed.However, it was able to be pushed back in, and the coil remained inside the patient.

• 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: 23838887
• Report Number: 2124215-2025-91703
• Device Sequence Number: 9958342
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: (01)08714729795513(17)280514(10)36524387
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133208
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0036524387
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/02/2026
• Date Device Manufactured: 05/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown