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

Model Number	83779
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11sep2024.It was reported that an advancing issue occurred.A 22mm x 60cm interlock coil was selected for use in the embolization of a splenic aneurysm.A renegade stc 18 microcatheter was used; however, the coil could not completely be pushed out of the protective sheath.Half of the coil was in the microcatheter, and the other half was in the protective sheath.The device was withdrawn into the protective sheath, and the microcatheter was flushed, but after repeated attempts, the coil could not be pushed out.The coil was then withdrawn.The coil was observed to be stretched.Another of the same device was used.A total of 10 other coils were pushed in, and the procedure was successfully completed.No complications were reported, and the patient status was stable.However, returned device analysis revealed the coil arm was detached.
Additional Manufacturer Narrative
Device evaluated by mfr.: visual inspection observed that the main coil, the introducer sheath, and the pusher wire were returned.It was observed that the main coil was bent and stretched at the coil arm and primary coil section.Moreover, the arm of the coil was detached.Media review of the received pictures showed that the main coil was stretched.Microscopic inspection confirmed that the main coil was bent, stretched and detached.Functional testing could not be performed since the main coil and the pusher wire were not interlocking.Dimensional inspection was performed, and the main coil's max zap tip outer diameter (od) and primary coil od passed the specification test.

• Brand Name: INTERLOCK
• 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: 20360536
• Report Number: 2124215-2024-61615
• Device Sequence Number: 20635270
• Product Code: KRD
• UDI-Device Identifier: 08714729845324
• UDI-Public: 08714729845324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132578
• 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): 10/03/2024

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 Expiration Date: 07/16/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032225626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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: MICROCATHETER: STC18
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 60 KG