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U.S. Department of Health and Human Services

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

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DATASCOPE FAIRFIELD MEGA 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0497
Device Problems Pumping Stopped (1503); Device Contamination with Body Fluid (2317)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/03/2017
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. Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that after several days of intra-aortic balloon (iab) therapy, the pump stopped pumping. The iab was removed from the patient and the customer noticed dried blood in the iab catheter. There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath. The returned sheath was over the catheter. The extension tubing was also returned. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and one leak was detected on the membrane approximately 2. 3cm from the rear seal measuring 0. 03cm in length. The reported alarm and blood in tubing was most likely triggered by a leak which was found on the membrane. Under magnification, a whitish patch was observed around the leak. This whitish patch is the typical appearance of an abrasion mark which is caused by contact with calcified plaque in the aorta. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. Complaint # (b)(4).
 
Event Description
It was reported that after several days of intra-aortic balloon (iab) therapy, the pump stopped pumping. The iab was removed from the patient and the customer noticed dried blood in the iab catheter. There was no reported injury to the patient.
 
Manufacturer Narrative
Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that after several days of intra-aortic balloon (iab) therapy, the pump stopped pumping. The iab was removed from the patient and the customer noticed dried blood in the iab catheter. There was no reported injury to the patient.
 
Manufacturer Narrative
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 after several days of intra-aortic balloon (iab) therapy, the pump stopped pumping. The iab was removed from the patient and the customer noticed dried blood in the iab catheter. There was no reported injury to the patient.
 
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Brand NameMEGA 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 Key7154719
MDR Text Key250096423
Report Number2248146-2017-00750
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K091449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
Device Catalogue Number0684-00-0497
Device Lot Number3000041330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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