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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 Problems Restricted Flow rate (1248); Inflation Problem (1310)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2020
Event Type  malfunction  
Manufacturer Narrative
Event site postal code: (b)(6).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 record id#: (b)(4).
 
Event Description
It was reported that during intra-aortic balloon(iab) therapy, the console generated a iab catheter restriction alarm, and the iab was unable to inflate fully.The iab was removed.The customer used a 50cc syringe to test and inflate the iab.More force was applied and a pop sound was heard and the iab was then able to fully inflate.They noticed that certain part of the balloon was still folded and not fully inflated.A new iab was inserted to continue therapy.There was no reported adverse event or injury to the patient.
 
Manufacturer Narrative
Serial number from: unknown to: (b)(6).Device evaluation: the product was returned with the membrane completely unfolded with no visible blood on the exterior of the catheter.A catheter tubing/inner lumen kink was observed at approximately 1cm from the y-fitting.Additionally, a flat catheter tubing section was also observed at approximately 1.8cm from the membrane rear seal.An underwater leak test of the balloon, catheter tubing, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump for two hours, which represents one complete autofill cycle.The iab pumped normally and no alarm sounded.The reported event cannot be confirmed by the evaluation.However, kinks on the catheter tubing could cause alarms and/or difficulty inflating the iab.We were unable to duplicate the reported event.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).
 
Event Description
It was reported that during intra-aortic balloon(iab) therapy, the console generated a iab catheter restriction alarm and the iab was unable to inflate fully.The iab was removed.The customer used a 50cc syringe to test and inflate the iab.More force was applied and a pop sound was heard and the iab was then able to fully inflate.They noticed that certain part of the balloon was still folded and not fully inflated.A new iab was inserted to continue therapy.There was no reported adverse event or injury to the patient.
 
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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 Key10766499
MDR Text Key214763628
Report Number2248146-2020-00572
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 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2022
Device Model Number0684-00-0296-01
Device Catalogue Number0684-00-0497
Device Lot Number3000109189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Initial Date Manufacturer Received 10/08/2020
Initial Date FDA Received10/30/2020
Supplement Dates Manufacturer Received11/19/2020
Supplement Dates FDA Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
Patient Weight71
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