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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Material Rupture (1546)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2018
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 during an intra-aortic balloon (iab) insertion in a patient a blood leakage was found in the gas tube.The iab was removed and therapy was discontinued.It was noted that the balloon rupture occurred and blood leakage was found in the device.It is unknown if the pump alarm sounded.No patient injury was reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter.One kink was found on the catheter tubing and inner lumen approximately 76.5cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1.0cm from the rear seal measuring 0.03cm in length.The evaluation confirms the reported leak, blood in tubing problem.The reported blood in tubing 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.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 during an intra-aortic balloon (iab) insertion in a patient a blood leakage was found in the gas tube.The iab was removed and therapy was discontinued.It was noted that the balloon rupture occurred and blood leakage was found in the device.It is unknown if the pump alarm sounded.No patient injury was reported.
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7431926
MDR Text Key105676183
Report Number2248146-2018-00258
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/06/2020
Device Catalogue Number0684-00-0605
Device Lot Number3000057877
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Device AgeYR
Date Manufacturer Received04/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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