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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; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2020
Event Type  malfunction  
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.(b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the guide wire could not be advanced through the central lumen.A new iab was used and therapy was continued successfully.There was no reported injury to the patient.
 
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Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC
Type of Device
SYSTEM, 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 Key10186777
MDR Text Key196921529
Report Number2248146-2020-00303
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 Other
Type of Report Initial
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/06/2021
Device Catalogue Number0684-00-0605
Device Lot Number3000083941
Was Device Available for Evaluation? No
Date Manufacturer Received06/09/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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