Model Number M00545000 |
Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2024 |
Event Type
malfunction
|
Event Description
|
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a biopsy procedure performed on (b)(6) 2024.During the procedure, the wire in the sheath was damaged/defective.It was also reported that the handle was difficult to operate, and an unusual noise was observed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the malfunction of the device, despite good faith efforts.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a0402 captures the reportable event of wire break.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a0402 captures the reportable event of wire break.Block h10: investigation results.The returned rx cytology brush was analyzed, and it was found that the wire was damaged (buckled) inside the injection port, and it was not broken.In addition, the handle was not broken.The reported events of handle and wire break were not confirmed.The investigation finding of wire damaged (buckled) could have been generated due to excessive force applied possibly causing the working length to kink when the brush was extended or retracted.Based on all available information, the most probable root cause of the reported event is no problem detected.
|
|
Event Description
|
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a biopsy procedure performed on (b)(6) 2024.During the procedure, the wire in the sheath was damaged/defective.It was also reported that the handle was difficult to operate, and an unusual noise was observed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the malfunction of the device, despite good faith efforts.
|
|
Search Alerts/Recalls
|