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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD INSERTION KIT SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD INSERTION KIT SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number UNKNOWN
Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Patient Problems Skin Discoloration (2074); Vascular System (Circulation), Impaired (2572)
Event Date 02/05/2019
Event Type  Injury  
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 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 submission is for the 1st insertion kit attempted.
 
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Brand NameINSERTION KIT
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 Key8395539
MDR Text Key138000592
Report Number2248146-2019-00149
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,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
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?
Device Age YR
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? No
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: 03/06/2019 Patient Sequence Number: 1
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