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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0469-01
Device Problems Filling Problem (1233); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
(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 an autofill failure alarm.Blood was then noted inside the iab around the sheath seal area.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The iab was removed and a new iab was inserted via femoral artery.There was no patient harm or adverse event reported.
 
Manufacturer Narrative
Contact person occupation: clinical educator.The product was returned with the membrane completely unfolded with blood on the exterior of the catheter, within the statgard and between the catheter and the returned maquet sheath.The pressure tubing was also returned.A catheter tubing/inner lumen kink was observed at approximately 46.2cm from the iab tip.Additionally, a catheter tubing/inner lumen/optical fiber break was also observed near the y-fitting at approximately 75.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and pressure tubing was performed and a leak was detected at the catheter tubing/inner lumen/optical fiber break site.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, statgard and catheter tubing.However, we were unable to determine when this may have occurred.Additionally, kinks to the catheter tubing may contribute to an autofill failure.The evaluation confirmed the 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).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the console generated an autofill failure alarm.Blood was then noted inside the iab around the sheath seal area.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The iab was removed and a new iab was inserted via femoral artery.There was no patient harm or adverse event reported.
 
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Brand Name
SENSATION 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10871145
MDR Text Key219523764
Report Number2248146-2020-00622
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106755
UDI-Public10607567106755
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2022
Device Model Number0684-00-0469-01
Device Catalogue Number0684-00-0433
Device Lot Number3000106387
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
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