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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Injury (2348)
Event Date 10/05/2020
Event Type  Death  
Manufacturer Narrative
Event site postal code: (b)(6). The device was not returned, and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. There is currently a field action# res 85823 in process that is related to this event. Complaint #: (b)(4).
 
Event Description
An aortic valve replacement associated with pericardial patch (re-operation) was performed. A datascope trans ray plus 35cc intra-aortic balloon (iab) catheter was used along with an unknown datascope intra-aortic balloon pump (iabp) to provide iabp counterpulsation therapy as well. The surgery was completed successfully and iabp therapy was continued after the surgery. Three days later, the iabp therapy was discontinued and the iab catheter was removed safely from the patient. The iab catheter was discarded in the hospital. It was reported that after removal of the of the iab catheter, the patient condition deteriorated and a positive reaction was observed for endotoxin shock the following morning. There was no reported malfunction of the datascope intra-aortic balloon. A separate report has been sent for the iabp under mfg report number 2249723-2020-01771.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key10766106
MDR Text Key216115838
Report Number2248146-2020-00567
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0684-00-0604
Device Lot Number3000109191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/30/2020 Patient Sequence Number: 1
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