Catalog Number 0684-00-0475 |
Device Problem
Aspiration Issue (2883)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/09/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed, a supplemental report with our findings will be submitted.(b)(4).
|
|
Event Description
|
It was reported that during intra-aortic balloon (iab) therapy, the balloon was inserted normally, but the doctor was unable to aspirate blood from the inner lumen.The iab was replaced and therapy was able to be provided.There was no reported injury to the patient.
|
|
Manufacturer Narrative
|
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The technician was able to successfully aspirate/flush the inner lumen.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported difficult/unable to aspirate inner lumen event cannot be confirmed by the evaluation.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4).
|
|
Event Description
|
It was reported that during intra-aortic balloon (iab) therapy, the balloon was inserted normally, but the doctor was unable to aspirate blood from the inner lumen.The iab was replaced and therapy was able to be provided.There was no reported injury to the patient.
|
|
Manufacturer Narrative
|
Complaint # (b)(4).
|
|
Event Description
|
It was reported that during intra-aortic balloon (iab) therapy, the balloon was inserted normally, but the doctor was unable to aspirate blood from the inner lumen.The iab was replaced and therapy was able to be provided.There was no reported injury to the patient.
|
|
Search Alerts/Recalls
|