Catalog Number 0684-00-0474 |
Device Problems
Crack (1135); Device Displays Incorrect Message (2591)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/12/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up with the customer for its return.(b)(4).
|
|
Event Description
|
It was reported during intra-aortic balloon (iab) therapy it was noted that there was a crack a the iab.The customer also noted that there was an alarm for blood in balloon.The iab had to be replaced in order to continue therapy.There was no injury or harm to the patient.
|
|
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 during intra-aortic balloon (iab) therapy it was noted that there was a crack a the iab.The customer also noted that there was an alarm for blood in balloon.The iab had to be replaced in order to continue therapy.There was no injury or harm to the patient.
|
|
Manufacturer Narrative
|
Phone number of reporter: (b)(6).The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter.Dried blood was found occluding the inner lumen.The occlusion was able to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.5cm from the rear seal measuring 0.05cm in length.The reported blood in tubing & alarm was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.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 during intra-aortic balloon (iab) therapy it was noted that there was a crack a the iab.The customer also noted that there was an alarm for blood in balloon.The iab had to be replaced in order to continue therapy.There was no injury or harm to the patient.
|
|
Search Alerts/Recalls
|