Catalog Number IAB-S730C |
Device Problem
Inflation Problem (1310)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/06/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Sample was discarded.
|
|
Event Description
|
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not fully inflated.As a result the medical doctor (md) used another set to complete the procedure successfully.Additional information received on 11/1/16: the medical doctor (md) properly maintained the vacuum on the balloon and there was nothing special at that time.During the intra-aortic balloon pump (iabp) therapy, the medical doctor (md) noticed that the balloon was automatically deflated after inflation.The medical doctor (md) removed the failed catheter with sheath together and all of the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set replacement.The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site.There was no delay or interruption in therapy.There was no reported patient death, injury or complications.There was no harmful outcome to the patient.
|
|
Manufacturer Narrative
|
(b)(4).The product was not returned for evaluation.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint that the balloon would not inflate properly is not able to be confirmed.The product was not returned for evaluation.The root cause of the complaint is undetermined.
|
|
Event Description
|
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not fully inflated.As a result the medical doctor (md) used another set to complete the procedure successfully.Additional information received on 11/1/16: the medical doctor (md) properly maintained the vacuum on the balloon and there was nothing special at that time.During the intra-aortic balloon pump (iabp) therapy, the medical doctor (md) noticed that the balloon was automatically deflated after inflation.The medical doctor (md) removed the failed catheter with sheath together and all of the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set replacement.The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site.There was no delay or interruption in therapy.There was no reported patient death, injury or complications.There was no harmful outcome to the patient.
|
|
Manufacturer Narrative
|
(b)(4).Date was reported incorrect and corrected.
|
|
Event Description
|
It was reported that while in the cath lab the medical doctor (md) stated that the balloon was not fully inflated.As a result the medical doctor (md) used another set to complete the procedure successfully.Additional information received on 11/1/2016: the medical doctor (md) properly maintained the vacuum on the balloon and there was nothing special at that time.During the intra-aortic balloon pump (iabp) therapy, the medical doctor (md) noticed that the balloon was automatically deflated after inflation.The medical doctor (md) removed the failed catheter with sheath together and all of the procedure was conducted according to the instruction for use.The procedure was completed successfully after the catheter set replacement.The second intra-aortic balloon (iab) was inserted via a super-arrow flex sheath into the same insertion site.There was no delay or interruption in therapy.There was no reported patient death, injury or complications.There was no harmful outcome to the patient.
|
|
Search Alerts/Recalls
|