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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); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/19/2019
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 insertion of the intra-aortic balloon (iab) in an emergency case, the balloon was unable to be inserted due to the membrane becoming loose. The iab was removed and intra-aortic balloon (iab) therapy was discontinued. There was no reported injury to the patient.
 
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 insertion of the intra-aortic balloon (iab) in an emergency case, the balloon was unable to be inserted due to the membrane becoming loose. 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 NameTRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8591245
MDR Text Key144448417
Report Number2248146-2019-00415
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 05/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/10/2020
Device Catalogue Number0684-00-0605
Device Lot Number3000047040
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Is This a Reprocessed and Reused Single-Use Device? No

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