Catalog Number IAB-S730C |
Device Problems
Difficult to Insert (1316); Physical Resistance (2578)
|
Patient Problem
Cardiogenic Shock (2262)
|
Event Date 01/27/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Sample will not be returned for evaluation.
|
|
Event Description
|
It was reported that the event occurred in the cath lab.The md prepped the intra-aortic balloon (iab) via the instructions for use; he properly vacuumed the balloon catheter enough inside the tray.When inserting the iab into the super arrow-flex (saf) sheath the md met with severe resistance and as a result , the iab and saf sheath were removed as one unit.The md requested another iab and this iab was prepped and inserted into the same insertion site; the femoral artery.There was no reported patient death, injury or complications.There was a 15 minute delay in intra-aortic balloon pump (iabp) therapy, however no harm to the patient reported.Medical / surgical intervention was not required.The patient outcome is fine.
|
|
Manufacturer Narrative
|
(b)(4).Device evaluation: no product was returned for evaluation.The reported lot number indicates the product was expired upon use.The expiration date was august 2015.The product was used in (b)(6) 2016.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of insertion difficulty is not able to be confirmed.The reported lot number indicates the product was expired upon use.The root cause of the complaint is undetermined.
|
|
Event Description
|
It was reported that the event occurred in the cath lab.The md prepped the intra-aortic balloon (iab) via the instructions for use; he properly vacuumed the balloon catheter enough inside the tray.When inserting the iab into the super arrow-flex (saf) sheath the md met with severe resistance and as a result , the iab and saf sheath were removed as one unit.The md requested another iab and this iab was prepped and inserted into the same insertion site; the femoral artery.There was no reported patient death, injury or complications.There was a 15 minute delay in intra-aortic balloon pump (iabp) therapy , however no harm to the patient reported.Medical / surgical intervention was not required.The patient outcome is fine.
|
|
Search Alerts/Recalls
|