Model Number 1550250-33 |
Device Problems
Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/27/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The device was received.Investigation is not yet complete.A follow report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that the procedure was performed to treat a none tortuous, mildly calcified mid-right coronary artery that was 80% stenosed.The 2.50x33mm xience sierra balloon would not inflate.Eventually, the balloon partially inflated.The stent was post-dilated with an unspecified balloon and it remains in the lesion.It was then noted there was a leak from a pinhole in the shaft.There was no adverse patient sequela reported.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The reported shaft torn material, leak and inflation problems were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported shaft tear.The reported leak and inflation issues appear to be related to circumstances of the procedure as it is likely the inner member damage caused the leak and subsequent inflation issues (failure to inflate and irregular inflation).There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|