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

Model Number	M001363830
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524); 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	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device eval by mfr: the interlock coil was returned for analysis.A visual and microscopic inspection revealed that the main coil was returned with the zap tip detached.The coil was also bent and stretched along its primary coil.
Event or Problem Description
Reportable based on device analysis completed on 26nov2025.It was reported that the main coil was unable to advance to the catheter.During a procedure for a giant abdominal aortic aneurysm, a 20mm x 40cm interlock controllable coils were used to pack the tumor.Three 20mm x 40cm interlock coils were successfully deployed without issue.However, when attempting to deliver the fourth coil to the orifice of the angiography catheter, increased resistance was encountered, and the deploy angle could not be adjusted.Despite intermittent heparin water flushing, the issue persisted.Upon withdrawal, it was discovered that the interlocking arm of the coil was damaged.A new coil of the same specification was promptly replaced and deployed successfully, allowing the procedure to continue smoothly.In total, five 20mm x 40cm interlock coils were used, and the procedure was completed.The patient condition following the procedure was stable.However, device analysis revealed that the main coil had the zap tip detached.

• 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: 23830000
• Report Number: 2124215-2025-91455
• Device Sequence Number: 9267934
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: (01)08714729795445(17)270608(10)34198249
• 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): 12/17/2025

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: M001363830
• Device Catalogue Number: M001363830
• Device Lot Number: 0034198249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG