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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD MEGA 7.5FR. 30CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0292
Device Problem Backflow (1064)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
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).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was blood noted in the gas line. 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. The extracorporeal tubing was cut from the iab and not returned. A visual examination of the product detected the inner lumen within the catheter tubing near the y-fitting was completely separated within a kink approximately 76. 7cm from iab tip. An underwater leak test of the balloon, catheter and y-fitting was performed and one additional leak was found on the catheter tubing 47. 8cm from the iab tip. The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed and allowed blood to leak into the membrane and catheter tubing causing the reported problem. It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure. The evaluation confirmed the reported problem. Continual flexing of a kink can cause the catheter to become penetrated. It is difficult to determine when the penetration may have occurred, however, it could cause the reported event. The penetration found in the catheter tubing appears to have been caused by a sharp object. This may have occurred during iab removal from the patient. 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 during intra-aortic balloon (iab) therapy there was blood noted in the gas line. The indication for use was a bridge to transplant. 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 during intra-aortic balloon (iab) therapy there was blood noted in the gas line. There was no reported injury to the patient.
 
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Brand NameMEGA 7.5FR. 30CC 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 Key7144853
MDR Text Key252106442
Report Number2248146-2017-00731
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/25/2020
Device Catalogue Number0684-00-0292
Device Lot Number30000576840
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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