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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 Air Leak (1008); Backflow (1064)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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
After two days of intra-aortic balloon therapy, it was reported that there was helium loss in the intra-aortic balloon catheter and blood was seen in the tubing.The intra-aortic balloon was replaced and therapy continued successfully.There was no reported injury to the patient.
 
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
After two days of intra-aortic balloon therapy, it was reported that there was helium loss in the intra-aortic balloon catheter and blood was seen in the tubing.The intra-aortic balloon was replaced and therapy continued successfully.There was no reported injury to the patient.Additional information: the customer did not believe there was iab pump problem however the pump showed "heliumleck" and the customer was unsure if there was an alarm associated with it.The customer could not fill the helium pump.
 
Manufacturer Narrative
Date received by mfr changed from: 10/24/2017 to: 11/24/2017.Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.025cm in length.The reported alarms 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 calcified plaque in the aorta.The evaluation confirmed the reported problems.An abrasion leak is a known inherent risk and common failure mode caused by 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
After two days of intra-aortic balloon therapy, it was reported that there was helium loss in the intra-aortic balloon catheter and blood was seen in the tubing.The intra-aortic balloon was replaced and therapy continued successfully.There was no reported injury to the patient.Additional information: the customer did not believe there was iab pump problem however the pump showed "heliumleck" and the customer was unsure if there was an alarm associated with it.The customer could not fill the helium pump.
 
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Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, 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 Key7140007
MDR Text Key95929256
Report Number2248146-2017-00728
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K091449
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,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/30/2020
Device Catalogue Number0684-00-0497
Device Lot Number3000052336
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Is the Reporter a Health Professional? Yes
Device AgeYR
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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