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

Model Number	M001363630
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 19nov2025.It was reported that the coil was stuck in the catheter and became stretched.The patient presented with abdominal aortic aneurysm underwent embolization using a 12mm x 40cm interlock-35 and non-boston scientific catheter.However, during the procedure, the coil could not be pushed out of the catheter, and obvious resistance was felt when it was pushed to the middle of the catheter.It was judged that the coil was stuck in the catheter.After the physician withdrew the device from the patient's body and the catheter, it was noted that the coil became stretched.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.However, device analysis revealed that the arm coil was detached.
Additional Manufacturer Narrative
E1: (b)(6).G1: mfr site zip/post code: t12 yk88.Device evaluated by mfr: the main coil, the introducer sheath and the delivery wire were returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was necessary to make a cut in the introducer wire to remove the coil.It was observed that the main coil was bent and stretched at the primary coil section, the arm coil was detached.Dimensional inspection of the main coil revealed the components were within specifications.No other issues were identified during the product analysis.

• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23791014
• Report Number: 2124215-2025-90630
• Device Sequence Number: 13381141
• Product Code: KRD
• UDI-Device Identifier: 08714729792970
• UDI-Public: (01)08714729792970(17)271111(10)35254617
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 12/12/2025

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: M001363630
• Device Catalogue Number: M001363630
• Device Lot Number: 0035254617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: CATHETER - CORDIS C2.
• Patient Age: 70 YR
• Patient Sex: Female