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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/04/2021
Event Type  Death  
Manufacturer Narrative
Device not accessible for testing: at this time, the customer has not requested getinge to evaluate the iabp. Additional information is being requested with regard to the repair and status of the iabp. A supplemental report will be submitted if this information is provided to us. Not returned to manufacturer.
 
Event Description
It was reported that during insertion of an intra-aortic balloon in a patient with cardiac arrest post coronarography, the customer could not insert the guidewire through the iab and noted that the iab was broken after 12cm. A new iab was inserted without further issue. Therapy with an unknown intra-aortic balloon pump (iabp) was then provided. It was later reported that the patient had died. The customer does not attribute the patient's death to the iabp device and there was no reported malfunction of the iabp. This report is for the iabp used during the reported event. Separate reports have been submitted for the iab catheters in use. Reference report numbers: 2248146-2021-00699 and 2248146-2021-00698.
 
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Brand NameIABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12720559
MDR Text Key279054985
Report Number2249723-2021-02502
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
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 Received10/05/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1
Treatment
SENSATION 34CC
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