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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 35CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE 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 Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/01/2018
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. Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion into the sheath it was difficult to advance. Replaced iab to continue therapy. No patient injury was reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion into the sheath it was difficult to advance. Replaced iab to continue therapy. No patient injury was reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and traces of blood found on the exterior of the catheter. The extender tubing was also returned. The sheath was not returned for evaluation. Three kinks were found on the catheter tubing approximately 23. 1cm, 27. 7cm and 35. 3cm from the iab tip. The inner lumen was found to be occluded with dried blood. The occlusion was unable to be cleared. 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).
 
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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 FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7999624
MDR Text Key124967461
Report Number2248146-2018-00608
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 consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2021
Device Catalogue Number0684-00-0604
Device Lot Number3000073086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2018
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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