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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0296-01
Device Problem Leak/Splash (1354)
Patient Problem Injury (2348)
Event Date 09/10/2020
Event Type  Injury  
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.Complaint record id # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab began to leak and blood was seen in the helium tubing.The console was put on standby for 1.5 hours and the patient was heparinized before the iab was removed.Once the iab was being removed, it became stuck and needed to be removed surgically.This incident is caused by user, since they did not follow the instructions for use.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy, the iab began to leak and blood was seen in the helium tubing.The console was put on standby for 1.5 hours and the patient was heparinized before the iab was removed.Once the iab was being removed, it became stuck and needed to be removed surgically.This incident is caused by user, since they did not follow the instructions for use.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with blood on the exterior and interior of the catheter and between the catheter and the returned maquet sheath.The catheter tubing was flat/deformed near the y-fitting at approximately 74.7cm from the iab tip.An underwater leak test of the balloon, y-fitting, catheter tubing and extracorporeal tubing was performed and a leak was detected from a tear on the membrane approximately 2cm from the rear seal and measuring 0.8cm in length.The tear found appeared to had been caused by a sharp object.This tear occurred at a whitish patch location on the membrane, which is the typical appearance of an abrasion mark caused by a calcified plaque in the aorta.However, due to the location of the tear, we were unable to determine if there was an initial abrasion leak at the tear region.We were unable to determine when the tear may have occurred.The presence of blood inside the iab confirmed the reported problem.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).
 
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Brand Name
MEGA 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10612973
MDR Text Key209369901
Report Number2248146-2020-00516
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108001
UDI-Public10607567108001
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
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/17/2022
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot Number3000104730
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2020
Date Manufacturer Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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