Model Number M00558490 |
Device Problems
Human-Device Interface Problem (2949); Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/09/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Block h6: imdrf device code a040609 captures the reportable event of balloon tip bent.
|
|
Event Description
|
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, a photo of the device was provided by the customer and showed that the tip of the balloon catheter was bent.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
|
|
Event Description
|
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, a photo of the device was provided by the customer and showed that the tip of the balloon catheter was bent.The procedure was completed with the original device.There were no patient complications reported as a result of this event.
|
|
Manufacturer Narrative
|
Block h6: imdrf device code a040609 captures the reportable event of balloon tip bent.Block h10: investigation results the returned cre wireguided dilatation balloon was analyzed, and a visual and media inspection found that the tip of the guidewire was bent.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon tip bent was confirmed.The results of the analysis performed on the returned device found that the tip of the guidewire was bent.The tip bent found is likely to have occurred due to an excessive manipulation of the device without enough care during unpacking of the device.Therefore, the most probable root cause is an adverse event related to procedure.
|
|
Search Alerts/Recalls
|