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

Model Number	83779
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 12mar2024.It was reported that the coil could not be completely pushed out of the protective sheath, half in the microcatheter and half in the protective sheath.The target lesion was located in the iliac aneurysm.The 22mm x 60cm interlock was selected for use.During the procedure, an stc18 microcatheter was used for advancing the coil, however, it was noted that the coil could not be completely pushed out of the protective sheath, half in the microcatheter and half in the protective sheath.The coil still could not be pushed out even after several attempts.The coil was withdrawn, and the procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the pusher wire was detached at the coil section.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 primary coil section.Also, the pusher wire was bent at heat shrink tfe tubing and stretched, bent and detached at coil section.The functional could not be performed due the main coil and the pusher wire are not interlocking.Dimensional inspection of the pusher wire and main coil revealed the components were within specification.No other issues were identified during the product analysis.

• 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: 19027808
• Report Number: 2124215-2024-16258
• Device Sequence Number: 15483940
• 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): 04/02/2024

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: 06/12/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0032004764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG