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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD TRANS-RAY 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0513
Device Problems Obstruction of Flow (2423); Protective Measures Problem (3015)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2019
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
It was reported that during intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm.Although the console was replaced, the same alarm was generated repeatedly.The iab was removed and intra-aortic balloon (iab) therapy was discontinued.There was no reported injury to the patient.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm.Although the console was replaced, the same alarm was generated repeatedly.The iab was removed and intra-aortic balloon (iab) therapy was discontinued.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The extender tubing was also returned.The returned maquet sheath was partially over the catheter.Two kinks were found in the catheter tubing approximately 44.2 & 76.5 cm from the iab tip.Additionally, the sensor cable & extracorporeal tubing were returned cut in 2 pieces.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was not able to be placed on the cs300 pump due to its returned cut condition.The evaluation determined that there were two kinks in the catheter.It is difficult to determine how or when these kinks in the catheter occurred.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause an inflation difficulty or an alarm.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).
 
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 console generated a check iab catheter alarm.Although the console was replaced, the same alarm was generated repeatedly.The iab was removed and intra-aortic balloon (iab) therapy was discontinued.There was no reported injury to the patient.
 
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Brand Name
TRANS-RAY 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8568361
MDR Text Key143812001
Report Number2248146-2019-00397
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 07/30/2019
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 Date01/22/2021
Device Catalogue Number0684-00-0513
Device Lot Number3000065969
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Device Age YR
Initial Date Manufacturer Received 04/12/2019
Initial Date FDA Received05/01/2019
Supplement Dates Manufacturer Received06/14/2019
07/26/2019
Supplement Dates FDA Received07/11/2019
07/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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