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

Model Number	M001363820
Medical Device Problem Codes	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	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed that the main coil, the introducer sheath and the delivery wire were returned.The main coil was bent and stretched at the coil arm and primary coil section, moreover the arm coil was detached.Functional inspection could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection was performed, and the main coil's zap tip outer diameter (od) and primary coil od passed the specification test.Based on the evidence, the reported allegation of unable to advance main in the catheter could not be confirmed.The customer used a non-boston scientific diagnostic catheter.Other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.
Event or Problem Description
Reportable based on device analysis completed on 12dec2024.It was reported that the coil became stuck when pushed.A 15mm x 40cm interlock-35 coil was selected for embolization.During the procedure, the catheter was placed first, and then the 5f angiography catheter was used and reach the position.The interlock-18 and 35 coils were prepared in a sterile way and operated smoothly.When this device was used, it became stuck when pushed to the end.This coil could not be pushed out smoothly even if it was pulled back.The device was removed together with the microcatheter.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.However, returned device analysis revealed the arm coil was 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: 21048724
• Report Number: 2124215-2024-81841
• Device Sequence Number: 16996553
• Product Code: KRD
• UDI-Device Identifier: 08714729795438
• UDI-Public: 08714729795438
• 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): 12/31/2024

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: M001363820
• Device Catalogue Number: M001363820
• Device Lot Number: 0034120626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• 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: ANGIOGRAPHY CATHETER: 5F JOHNSON & JOHNSON
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG