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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-31
Device Problems Entrapment of Device (1212); Retraction Problem (1536); Physical Resistance (2578); Device Displays Incorrect Message (2591)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 07/22/2017
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. The company representative evaluated the unit and reported that this event was caused by a hole in the catheter and the intra aortic balloon pump (iabp) performed as expected in this situation.
 
Event Description
The intra aortic balloon (iab) was inserted into the patient in the cardiac intensive care unit (icu) post mitral valve replacement (mvr), aortic valve replacement (avr) and coronary artery bypass graft (cabg) for low cardiac output and patient deterioration. This was conducted by the surgeon without image intensifier. The cardiosave later alarmed "gass loss in iab circuit". The extra corporeal tubing was assessed and blood was noted. This occurred 12 hours after the iab was inserted. The cardiosave was stopped in order to attempt to remove the iab, resistance was found so the patient was taken to the operating room (or) for removal of the iab. A new iab was inserted under image intensifier in vascular or. Related balloon medwatch 2248146-2017-00314.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key6816696
MDR Text Key83492033
Report Number2249723-2017-00330
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K112372
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 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-0800-31
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2012
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: 08/24/2017 Patient Sequence Number: 1
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