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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problems Material Rupture (1546); Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 03/11/2018
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 a post operation liver transplant patient was on day four of intra-aortic balloon (iab) therapy and frank blood was noted in the gas line and the console alarmed "gas leak". The customer stated the iab was advanced the night before as per last cxr (chest x-ray) but no new x-ray was done to confirm placement. Balloon was removed and not replaced. Balloon gas line was inflated after removal with saline and balloon was patent with no leaks. The customer thought the inner gas line/pressure transducer line ruptured. Patient was stable without iab, on crrt (continuous renal replacement therapy) and awaiting re-do liver transplant. Patient was on intubated and on ventilator but was hemodynamically stable and did not require replacement of iab catheter. The indication for use was cardiogenic shock. There were no injuries reported to the patient.
 
Event Description
It was reported that a post operation liver transplant patient was on day four of intra-aortic balloon (iab) therapy and frank blood was noted in the gas line and the console alarmed "gas leak". The customer stated the iab was advanced the night before as per last cxr (chest x-ray) but no new x-ray was done to confirm placement. Balloon was removed and not replaced. Balloon gas line was inflated after removal with saline and balloon was patent with no leaks. The customer thought the inner gas line/pressure transducer line ruptured. Patient was stable without iab, on crrt (continuous renal replacement therapy) and awaiting re-do liver transplant. Patient was on intubated and on ventilator but was hemodynamically stable and did not require replacement of iab catheter. The indication for use was cardiogenic shock. There were no injuries reported to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter. The pressure tubing was also returned. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and one leak was detected on the membrane approximately 1. 8cm from the rear seal measuring 0. 076cm in length. The reported problem 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. The evaluation confirmed the reported problem. An abrasion leak is a known inherent risk and common failure mode caused by calcified plaque in the aorta. We are unable to confirm the reported iab migration because we are unable to mimic the clinical setting. 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).
 
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Brand NameLINEAR 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7402290
MDR Text Key104809604
Report Number2248146-2018-00239
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/16/2020
Device Catalogue Number0684-00-0475
Device Lot Number3000059924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

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