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

Model Number	M001363830
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	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 15feb2025.It was reported that the device could not be delivered out of the catheter and stretched.The target lesion was located in the hepatic portal vein.A 20mm x 40cm interlock-35 coil was selected for use.During the procedure, it was noted that the device could not be delivered out of the non-boston scientific catheter, and obvious resistance was felt when the device was delivered to the middle of the catheter.Because the device was stuck in the catheter, the physician removed the device and the catheter together from the patient's body.Consequently, the coil was stretched upon removal.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.However, returned device analysis revealed the main coil was detached at the coil arm.
Additional Manufacturer Narrative
Device evaluated by mfr: only the main coil was returned to our post market quality assurance laboratory.Visual and microscopic inspections were performed, and it was observed that the main coil was bent and stretched at the coil arm and primary coil section.Moreover, the main coil was detached at coil arm.The functional could not be performed due only the main coil was returned.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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21598548
• Report Number: 2124215-2025-15360
• Device Sequence Number: 8878146
• Product Code: KRD
• UDI-Device Identifier: 08714729795445
• UDI-Public: 08714729795445
• 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): 03/13/2025

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: 0032910257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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: ANGIOGRAPHY CATHETER - CORDIS 5F
• Patient Age: 54 YR
• Patient Sex: Male