Catalog Number 0684-00-0549-02 |
Device Problems
Material Rupture (1546); Device Displays Incorrect Message (2591)
|
Patient Problems
Arteriosclerosis (1722); Calcium Deposits/Calcification (1758); No Code Available (3191)
|
Event Date 10/30/2017 |
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.(b)(4).
|
|
Event Description
|
It was reported that intra-aortic balloon (iab) therapy was started on (b)(6) 2017 on an unstable angina pectoris patient.On (b)(6) 2017 at 1pm a ¿check iab catheter¿ alarm was generated by the pump.At 6am the same alarm ¿check iab catheter¿ was generated again and blood was found in the catheter.The customer suspected balloon rupture; iab was removed and iab therapy was discontinued.No patient injury was reported.Severe sclerosis and calcification in the artery, and mild tortuosity were noted in the patient vessel.
|
|
Manufacturer Narrative
|
Correction: the device was returned as of 12/13/2017 and should have been included on the initial mdr submission.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.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 2.0cm from the rear seal measuring 0.02cm in length.The reported alarm, check iab catheter & blood in tubing 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); record # (b)(4).
|
|
Event Description
|
It was reported that intra-aortic balloon (iab) therapy was started on (b)(6) 2017 on an unstable angina pectoris patient.On (b)(6) 2017 at 1pm a ¿check iab catheter¿ alarm was generated by the pump.At 6am the same alarm ¿check iab catheter¿ was generated again and blood was found in the catheter.The customer suspected balloon rupture; iab was removed and iab therapy was discontinued.No patient injury was reported.Severe sclerosis and calcification in the artery, and mild tortuosity were noted in the patient vessel.
|
|
Manufacturer Narrative
|
Complaint # (b)(4).
|
|
Event Description
|
It was reported that intra-aortic balloon (iab) therapy was started on (b)(6) 2017 on an unstable angina pectoris patient.On (b)(6) 2017 at 1pm a ¿check iab catheter¿ alarm was generated by the pump.At 6am the same alarm ¿check iab catheter¿ was generated again and blood was found in the catheter.The customer suspected balloon rupture; iab was removed and iab therapy was discontinued.No patient injury was reported.Severe sclerosis and calcification in the artery, and mild tortuosity were noted in the patient vessel.
|
|
Search Alerts/Recalls
|