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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. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0604
Device Problems Difficult to Insert (1316); Unraveled Material (1664); Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
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 the insertion of an intra-aortic balloon (iab), the membrane became unfurled and was unable to be inserted. Another iab was used to continue therapy. There was no reported patient injury.
 
Manufacturer Narrative
Serial number: (b)(4). 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 the insertion of an intra-aortic balloon (iab), the membrane became unfurled and was unable to be inserted. Another iab was used to continue therapy. There was no reported patient injury.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and with traces of blood found on the exterior of the catheter. The one-way valve was returned attached to the catheter. The catheter tubing was observed to be flattened along its length. This may occur if a vacuum is held with the one-way valve attached for a long period of time on the catheter causing the catheter tubing to lose its round shape. The one-way valve was vacuum tested and it held vacuum. 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 and extracorporeal 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 nonconformances were found that are considered to be related to the event. (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the membrane became unfurled and was unable to be inserted. Another iab was used to continue therapy. There was no reported patient injury.
 
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Brand NameTRANS-RAY PLUS 7.5 FR. 35CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8483385
MDR Text Key141057356
Report Number2248146-2019-00270
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 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/04/2021
Device Catalogue Number0684-00-0604
Device Lot Number3000085806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2019
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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