Model Number 7585 |
Device Problem
Break (1069)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 04/29/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that shaft break occurred.A 2.00mm x 15mm maverick balloon catheter was selected for use.However, it was noted that the shaft was fractured outside the body upon introduction.The procedure was completed with another of the same device.No patient's complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 65cm distal of the strain relief.There was contrast and blood in the inflation lumen.The balloon was loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
|
|
Event Description
|
It was reported that shaft break occurred.A 2.00mm x 15mm maverick balloon catheter was selected for use.However, it was noted that the shaft was fractured outside the body upon introduction.The procedure was completed with another of the same device.No patient's complications were reported and the patient's status was stable.
|
|
Search Alerts/Recalls
|