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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORPORATION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORPORATION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0576-01U
Device Problem Material Rupture (1546)
Patient Problems Dyspnea (1816); Pain (1994)
Event Date 11/12/2018
Event Type  malfunction  
Event Description
A patient with hypertension and peripheral vascular disease (pvd) experienced shortness of breath (sob) and left arm pain for twenty-four hours presented to the ed with inferior st elevations. Percutaneous intervention attempted but aborted due to level of severe calcific multi-vessel coronary disease. Iabp placed with plan to transfer patient to a tertiary center. While in icu, the iabp ruptured; balloon successfully removed. Due to patient's progressive disease further interventions not advised. Patient discharged to home with hospice. Per hospital, manufacturer made aware and provided a return mailing container with a complaint number "provider" by the manufacturer.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORPORATION
15 law dr
fairfield NJ 07004
MDR Report Key8159287
MDR Text Key130174342
Report Number8159287
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 12/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0576-01U
Device Lot Number3000082983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2018
Event Location Hospital
Date Report to Manufacturer12/13/2018
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

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