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

Model Number	83779
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the interlocking arm was detached.The target lesion was located in the internal iliac artery.A 10mm x 30cm interlock was selected for use.During the procedure, stc18 microcatheter together with a non boston scientific single curve catheter was used to deliver the coil, however it was felt abnormally unsmooth, and the coil could no longer be advanced after delivered half into the patient's body.It was noted that the delivery guidewire was severely bent, and during recapturing, it was noted that it could not be withdrawn into the protector.It had to be completed removed and the interlocking arm detached.The procedure was then completed with another of same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the introducer sheath and the pusher wire were returned with a non-boston scientific (bsci) catheter.It was observed that the pusher wire was bent at the coil, heat shrink tetrafluoroethylene (tfe) tubing and end pusher wire.The functional could not be performed due the main coil and the pusher wire are not interlocking.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the interlocking arm was detached.The target lesion was located in the internal iliac artery.A 10mm x 30cm interlock was selected for use.During the procedure, stc18 microcatheter together with a non boston scientific single curve catheter was used to deliver the coil, however it was felt abnormally unsmooth, and the coil could no longer be advanced after delivered half into the patient's body.It was noted that the delivery guidewire was severely bent, and during recapturing, it was noted that it could not be withdrawn into the protector.It had to be completed removed and the interlocking arm detached.The procedure was then completed with another of same device.No complications were reported, and the patient was stable post procedure.

• 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: 18707372
• Report Number: 2124215-2024-05162
• Device Sequence Number: 8508484
• Product Code: KRD
• UDI-Device Identifier: 08714729765035
• UDI-Public: 08714729765035
• 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,Followup
• Report Date (Section B): 03/29/2024

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: 06/02/2026
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0031938697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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: CORDIS; MICROCATHETER: CORDIS
• Patient Age: 55 YR
• Patient Sex: Female