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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - 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 Leak/Splash (1354); Difficult to Remove (1528); Defective Component (2292); Difficult to Advance (2920)
Patient Problem Death (1802)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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
Intra-aortic balloon (iab) therapy was started in a patient with cardiopulmonary arrest.Condensation was observed inside of the catheter tubing and was manually removed.15 hours later, blood was observed in the tubing.The console generated an iab catheter restriction alarm.The iab catheter was attempted to be retracted in the sheath but it could not be pulled back into the sheath.Thus both the iab catheter and the sheath were required to remove as a unit from the patient.Prior to removal of the devices, a guidewire was attempted to be delivered through the iab catheter in order to remain the access to the proper position for placing in the descending aorta for the replacement device.However, the guidewire got stuck within the iab catheter during its delivery.Therefore, whole device including the guidewire, iab catheter and the sheath was removed from the patient.After removal of the devices, when the retrieved iab catheter was checked visually outside of the patient, the inner lumen of the balloon was found to have been damaged around its proximal portion.Another iab catheter was used instead to continue the iabp therapy.During therapy, the physician determined that the patient would not be able to recover and therapy was discontinued with the consent of the family.Approximately one to two days after discontinuation of the iabp therapy, the patient was reported to expire.The facility does not attribute the death to either device.This report is for the first iab catheter used, which was replaced to continue therapy.
 
Manufacturer Narrative
The product was returned in two separate pieces, with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.The catheter tubing was cut and separated approximately 35.8cm from the iab tip.A visual examination of the product detected the inner lumen within the membrane was completely separated within a kink approximately 23.1cm from iab tip.The technician attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was not able to clear the occlusion and dried blood was observed at the tip of the guide wire.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no other leaks were detected.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported alarm, leak, & damaged component problems.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.The difficulty to advance guidewire was confirmed.We are unable to confirm the difficult to remove iab through sheath due to the returned condition of the catheter.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.Reference complaint # (b)(4).
 
Event Description
Intra-aortic balloon (iab) therapy was started in a patient with cardiopulmonary arrest.Condensation was observed inside of the catheter tubing and was manually removed.15 hours later, blood was observed in the tubing.The console generated an iab catheter restriction alarm.The iab catheter was attempted to be retracted in the sheath but it could not be pulled back into the sheath.Thus both the iab catheter and the sheath were required to remove as a unit from the patient.Prior to removal of the devices, a guidewire was attempted to be delivered through the iab catheter in order to remain the access to the proper position for placing in the descending aorta for the replacement device.However, the guidewire got stuck within the iab catheter during its delivery.Therefore, whole device including the guidewire, iab catheter and the sheath was removed from the patient.After removal of the devices, when the retrieved iab catheter was checked visually outside of the patient, the inner lumen of the balloon was found to have been damaged around its proximal portion.Another iab catheter was used instead to continue the iabp therapy.During therapy, the physician determined that the patient would not be able to recover and therapy was discontinued with the consent of the family.Approximately one to two days after discontinuation of the iabp therapy, the patient was reported to expire.The facility does not attribute the death to either device.This report is for the first iab catheter used, which was replaced to continue therapy.
 
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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 CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8653557
MDR Text Key146478834
Report Number2248146-2019-00444
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 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/20/2019
Device Catalogue Number0684-00-0605
Device Lot Number3000085807
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Initial Date Manufacturer Received 05/07/2019
Initial Date FDA Received05/30/2019
Supplement Dates Manufacturer Received06/20/2019
Supplement Dates FDA Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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