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

Model Number	83779
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A pusher wire and introducer sheath were returned inside a catheter.The pusher wire was inspected and was found kinked.The introducer sheath was inspected, and no damages were found, it had blood inside.Microscopic inspection revealed that the proximal end of the pusher wire has a smooth surface and the interlocking arm was inspected, and it was detached.The main coil was not returned, and the reported event "coil jammed" could not be confirmed.Dimensional inspection revealed that the overall dimension of the proximal tfe matches with specification, however, the core length did not match with the specification.The pusher wire was found broken.
Event or Problem Description
Reportable based on device analysis completed on 08oct2021.It was reported that the coil became stuck in the catheter.The target lesion was located in the abdominal aorta.An 8mm x 20cm interlock was selected for use.During the procedure, it was noted that the coil could not be delivered out and was stuck in the middle of the catheter.After repeated attempts, the physician slowly pulled the device backward, and found that it was stretched.The device was then replaced with another interlock, however, the coil still could not be delivered.The procedure was continued after the device was withdrawn again.There were no complications reported and the patient is stable.However, device investigations revealed that the interlocking arm was detached and the pusher wire was broken.

• Brand Name: INTERLOCK
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12740825
• Report Number: 2134265-2021-13430
• Device Sequence Number: 4099499
• Product Code: KRD
• UDI-Device Identifier: 08714729765011
• UDI-Public: 08714729765011
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: 02/07/2024
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0026939719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 72