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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2021
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).
 
Event Description
It was reported that during insertion of the intra-aortic balloon (iab), the balloon membrane became unfurled and the iab could not be inserted into the sheath. As the patient was stable, another iab was not inserted. There was no patient harm or adverse event reported.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 
MDR Report Key11948482
MDR Text Key254590544
Report Number2248146-2021-00365
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
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0605
Device Lot Number3000119351
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/07/2021 Patient Sequence Number: 1
Treatment
UNKNOWN.
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