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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. There was no reported malfunction of the involved iabp, and the serial number was not provided to us. However, upon investigation, we were advised that the therapy was terminated prior to removing the balloon, thus the iabp was stopped prior to removing the balloon. In addition, the perfusionist stated that the iabp was not in the or when they were addressing the situation. No further investigation is required. Not returned to manufacturer.
 
Event Description
It was reported after intra-aortic balloon pump (iabp) therapy ended, the clinical team removed the balloon catheter from the patient artery and tore the femoral artery. They emergently moved the patient to the operating room to control the situation and complete removal of the balloon. After removing the balloon catheter, the team is describing that the tip of the balloon catheter was melted. The balloon catheter was not replaced. Indication for use of the iabp therapy was to wean the patient from cardiopulmonary bypass. No patient death occurred. Please refer to mfg report number 2248146-2020-00282 for information on the involved balloon catheter.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10143730
MDR Text Key194938374
Report Number2249723-2020-00898
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/11/2020 Patient Sequence Number: 1
Treatment
IAB SENSATION 34CC
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