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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 Difficult to Insert (1316); Leak/Splash (1354); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2019
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab catheter was unable to be passed through the sheath due to resistance.Although the customer tried to insert the same iab catheter with another sheath, gave up the use of the iab due to blood found in the catheter tube.Another iab catheter was used to continue procedure.There was no reported injury to the patient.
 
Manufacturer Narrative
Sex being changed from [february 4,2019] to [february 3,2019].The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The extender tubing was also returned.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, extracorporeal and extender 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.Complaint # (b)(4), record # 195977.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab catheter was unable to be passed through the sheath due to resistance.Although the customer tried to insert the same iab catheter with another sheath, gave up the use of the iab due to blood found in the catheter tube.Another iab catheter was used to continue procedure.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab catheter was unable to be passed through the sheath due to resistance.Although the customer tried to insert the same iab catheter with another sheath, gave up the use of the iab due to blood found in the catheter tube.Another iab catheter was used to continue procedure.There was no reported 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 extender tubing was also returned.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, extracorporeal and extender 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.Complaint # (b)(4), record # (b)(4).
 
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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 Key8379628
MDR Text Key138134540
Report Number2248146-2019-00140
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,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/15/2021
Device Catalogue Number0684-00-0605
Device Lot Number3000082758
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Device Age YR
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/28/2019
Supplement Dates Manufacturer Received04/04/2019
05/28/2019
Supplement Dates FDA Received04/09/2019
05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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