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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS IAB CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION PLUS IAB CATHETER SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Low Blood Pressure/ Hypotension (1914); Swelling (2091); Cardiac Tamponade (2226)
Event Date 07/06/2017
Event Type  Injury  
Manufacturer Narrative
Event date added to section date of event. (b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter was removed with femostop applied. The customer had some concern after the removal due to a swelling rif however it was thought to be due to the position of the femostop. The patient's blood pressure dropped to 59/39 and fluids were given. A ct scan was performed immediately. Once the bleeding point was identified the patient was taken to the cath lab for a cardiac tamponade. The vascular surgeons stated that there has been difficulty when removing this type of iab catheters in comparison to the non-fiber optic model. However the facility does not attribute the injury to the device.
 
Manufacturer Narrative
The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that the intra-aortic balloon (iab) catheter was removed with femostop applied. The customer had some concern after the removal due to a swelling rif however it was thought to be due to the position of the femostop. The patient's blood pressure dropped to 59/39 and fluids were given. A ct scan was performed immediately. Once the bleeding point was identified the patient was taken to the cath lab for a cardiac tamponade. The vascular surgeons stated that there has been difficulty when removing this type of iab catheters in comparison to the non-fiber optic model. However the facility does not attribute the injury to the device. The event date is unknown.
 
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Brand NameSENSATION PLUS IAB CATHETER
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key6817142
MDR Text Key250908362
Report Number2248146-2017-00323
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/24/2017
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? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/24/2017 Patient Sequence Number: 1
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