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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 Problems Difficult to Insert (1316); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2019
Event Type  malfunction  
Manufacturer Narrative
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. (b)(4).
 
Event Description
It was reported that a patient required intra-aortic balloon pump (iabp) therapy for support post-operatively. The surgeon was unable to insert the intra-aortic balloon (iab) in theatre due to poor peripheral access and so patient went to the intensive therapy unit with no support. It was reported that the surgeon went through 2 introducer kits because the guidewires and dilators kept kinking. It was decided by the intensivist later on in the night that the patient required circulatory support, and so he attempted to insert a 50cc fiber optic iab catheter. This was successful, but was reported to be difficult to do. It was necessary to use a sheath to maintain patency of the vessel as the patient had a very large abdomen. Patient subsequently went back to theatre for extracorporeal membrane oxygenation (ecmo) support; by this point the leg on the balloon side was white. It was reported that the surgeon then had difficulty removing the balloon and he expected it to be able to pass through the sheath. The surgeon indicated the event was traumatic for the patient and that the patient had to have vascular repair. It was reported that the insertion kits were both disposed of upon completion and the lot information was not retained. This report is for the iab kit that was able to be inserted and used.
 
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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
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key8384022
MDR Text Key138133630
Report Number2248146-2019-00148
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number0684-00-0575
Device Lot Number3000079460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received04/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
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: 03/01/2019 Patient Sequence Number: 1
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