Catalog Number NCSP2509X |
Device Problem
Burst Container or Vessel (1074)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/07/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
During a procedure an attempt was made to use one nc sprinter legend ptca balloon catheter to treat a lesion.It was reported that the patient had a stent implanted and that the nc sprinter did not reach normal pressure and burst.It was replaced by another ptca balloon catheter and the procedure was successfully completed.The patient is alive with no injury.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
The lesion was in the lcx.The device was intended to post dilate a deployed stent.The device was inspected before use with no issues noted.Negative prep/purging was performed on the device prior to use, with no issues noted.No resistance was noted while advancing the device to the lesion.The balloon burst at 16 atm.The device was moved or repositioned while inflated.The burst did not occur on the first inflation.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|