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

Model Number	M001363800
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); 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	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the main coil, the introducer sheath and the delivery wire were returned for evaluation.It was observed that the main coil was bent and stretched along the primary coil.Additionally, it had the coil arm detached.It was also observed that the delivery wire had a jumped coil.Dimensional inspection of the main coil and delivery wire revealed the components were within specification.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 19jan2026.It was reported that coil was unable to be withdrawn from the catheter and was prematurely detached.The target lesion was located in the abdominal aorta and left common iliac artery.A 10mm x 40cm interlock 35 was selected for use.During the procedure, there was no resistance to delivering in the catheter.When the pushing rod was delivered at one third, there was resistance.The coil still could not be delivered after several attempts, and then it was found that it had been detached in the catheter.Then the physician opened another coil, and there was no resistance to delivering in the catheter.After reaching the embolization position, the tip end was coiled up normally.However, since the embolization position was not ideal, the coil was attempted to be removed, but it was found that it could not be withdrawn and delivered.One half of the coil was in the catheter lumen.After withdrawal, it was found that the coil had been detached.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.However, device analysis revealed coil arm 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: 24344998
• Report Number: 2124215-2026-08499
• Device Sequence Number: 9836230
• Product Code: KRD
• UDI-Device Identifier: 08714729795513
• UDI-Public: (01)08714729795513(17)280415(10)36311934
• 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): 02/16/2026

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: M001363800
• Device Catalogue Number: M001363800
• Device Lot Number: 0036311934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 42 KG