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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems Hemorrhage/Bleeding (1888); Weakness (2145); Loss of consciousness (2418)
Event Date 11/20/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was frank blood noted in gas line and the patient became unresponsive. When the patient woke up there was weakness on one side. It was noted the patient had to undergo an embolectomy, but regained movement of all extremities. A new iab was inserted via the "axiallary" approach, which is an off-label use. The serious injury was not attributed to the device by the facility.
 
Manufacturer Narrative
Incorrect device returned by customer. Customer is not returning the catheter. (b)(4). [from] the product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. [to] the device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was frank blood noted in gas line and the patient became unresponsive. When the patient woke up there was weakness on one side. It was noted the patient had to undergo an embolectomy, but regained movement of all extremities. A new iab was inserted via the axiallary approach, which is an off-label use. The serious injury was not attributed to the device by the facility.
 
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Brand NameSENSATION PLUS 8FR. 50CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8152023
MDR Text Key129969113
Report Number2248146-2018-00709
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0575
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/14/2018
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/11/2018 Patient Sequence Number: 1
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