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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP SENSATION PLUS 8FR, 50CC FIBER OPTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP SENSATION PLUS 8FR, 50CC FIBER OPTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576
Device Problems Unintended Ejection (1234); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Event Description
During an insertion of an intra aortic balloon (iab) catheter, the balloon failed (leaking). The iab catheter was explanted and a new one was replaced. No adverse out come to patient. Product and packaging was not saved.
 
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Brand NameSENSATION PLUS 8FR, 50CC FIBER OPTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP
15 law drive
fairfield NJ 07004
MDR Report Key11929507
MDR Text Key254003967
Report Number11929507
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0684-00-0576
Device Catalogue Number0684-00-0576
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2021
Event Location No Information
Date Report to Manufacturer06/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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