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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 Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2019
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. Complaint record id # (b)(4). Device not returned.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy in an acute myocardial infarction patient, the console generated an autofill failure alarm. The iabp therapy was unable to be started. The balloon was replaced to continue therapy. There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter. The extender tubing were also returned. One kink was found on the catheter tubing approximately 43. 2cm from the iab tip. The catheter tubing was observed to be oval shaped 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. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected. The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle. The iab pumped normally and no alarm sounded from the pump. The evaluation determined there was a kink in the catheter. It is difficult to determine when or how a kink in the catheter occurs. Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause 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. Reference complaint #(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy in an acute myocardial infarction patient, the console generated an autofill failure alarm. The iabp therapy was unable to be started. The balloon was replaced to continue therapy. There was no reported injury to the patient.
 
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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 Key8667580
MDR Text Key149785134
Report Number2248146-2019-00453
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
0 Patients were Involved in the Event:
Date FDA Received06/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2021
Device Catalogue Number0684-00-0604
Device Lot Number3000082759
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No

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