Catalog Number 0684-00-0475 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/15/2017 |
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 that the intra-aortic balloon has come apart from the t-handle protector and was opened.
The customer noted this prior to the procedure and did not use the product.
There was no injury to the patient.
|
|
Manufacturer Narrative
|
The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.
The sheath was not returned for evaluation.
A laboratory insertion test was unable to be performed due to the membrane being unfurled.
An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.
A leak may impact the ability to maintain vacuum.
We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.
An evaluation of the product was unable to duplicate the reported problem.
The product performed according to specification.
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.
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon has come apart from the t-handle protector and was opened.
The customer noted this prior to the procedure and did not use the product.
There was no injury to the patient.
|
|
Search Alerts/Recalls
|