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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Paraplegia (2448)
Event Type  Injury  
Manufacturer Narrative
No further investigation will/can be performed due to the limited information provided in the article and there was no alleged malfunction of the iabp. Maquet will continue to monitor for similar issues. Complaints are reviewed on a monthly basis (post market data review meeting / quarterly management review meeting) to identify trends that may require further action (e. G. Capa) no model or serial number of the alleged iabp involved in the event was provided and therefore no review of the production device history record (dhr) can be performed.
 
Event Description
This event is being reported per the publication (by francis and taylor group) originating from the (b)(6), and where it was reported a patient (male, (b)(6)) with inferior st elevation myocardial infarction (stemi); suffered from spinal cord infarction and subsequent paraplegia (i. E. Paralysis of the legs and lower body) after intra-aortic balloon (iab) therapy. The hospital and although there is no scientific data to date supporting the claim, suggests in the publication the iab therapy could potentially have been the cause for the spinal cord infarction and subsequent paraplegia in patient. It should also be mentioned, during the time the patient was receiving iab therapy no malfunction of the intra-aortic balloon pump (iabp) was reported and the patient was eventually removed from iab therapy once the patient was found to be hemodynamically stable and after a transthoracic echocardiogram was performed. For further information please refer the aforementioned publication by the francis and taylor group (publisher article acceptance date 16aug2016), titled spinal cord infarction post cardiac arrest in stemi: a potential complication of intra-aortic balloon pump use'. This report is being opened as a iabp complaint because the article clearly stated that a maquet iabp pump was involved in the event, however no alleged malfunction of the pump was reported. The injury is associated with a balloon however there were no reports of a maquet balloon being utilized in therapy.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE CORP.
14 philips parkway
montvale NJ 07645
Manufacturer Contact
14 philips parkway
montvale, NJ 07645
MDR Report Key6107607
MDR Text Key60077289
Report Number2249723-2016-00035
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/16/2016 Patient Sequence Number: 1
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