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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144)
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. If additional information is provided, a supplemental report will be submitted.
 
Event Description
This complaint was reported by getinge's corporate medical affairs manager via an article in the 22nd annual scientific meeting, hfsa s119 / s120 journal of cardiac failure vol. 24 no. 8s august 2018. As follows: after 13 days of intra-aortic balloon pump (iabp) therapy on an unknown iabp, a (b)(6) male with end stage heart failure on a bridge to transplant experienced abdominal pain, nausea, and vomiting. The intra-aortic balloon catheter (iabc) was by percutaneous axillary insertion and an abdominal ct scan showed the intra-aortic balloon catheter (iabc) tip and distal segments in sma (superior mesenteric artery). The iabc was exchanged and the pain was resolved. Percutaneous axillary insertion of getinge's iabcs' are off-label use. The article did not provide any information on whether the balloon pump in use at the time was a maquet/getinge intra-aortic balloon pump or allege a malfunction thereof of the involved iabp; however, the event site is a getinge account. A getinge service territory manager (stm) contacted the customer and was advised that no patient information or further event details was available. A separate report was submitted on the iabc suspected to be involved in this event under medwatch #2248146-2018-00651.
 
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Brand NameUNKNOWN
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 Key8072718
MDR Text Key127208061
Report Number2249723-2018-01969
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received10/19/2018
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: 11/15/2018 Patient Sequence Number: 1
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