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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0576-01
Device Problems Leak/Splash (1354); Unraveled Material (1664)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/23/2020
Event Type  malfunction  
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.Complaint record id # (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the customer saw blood and noticed the iab was punctured due to the balloon membrane not being wrapped tightly.A new iab was inserted successfully.There was no patient injury or adverse event reported.
 
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.Reference complaint # (b)(4).
 
Event Description
It was reported that during the insertion of an intra-aortic balloon (iab), the customer saw blood and noticed the iab was punctured due to the balloon membrane not being wrapped tightly.A new iab was inserted successfully.There was no patient injury or adverse event reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The one-way valve was also returned and attached to the extracorporeal tubing.The catheter tubing was observed to be flattened along its length.This may occur if a vacuum is held with the one-way valve for an extended period of time, causing the catheter tubing to lose its round shape.A catheter tubing kink was observed near the y-fitting at approximately 75.7cm from the iab tip.The one-way valve was vacuum tested and it held vacuum.An insertion test was unable to be performed due to the returned condition of the iab.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.We are unable to confirm the reported problem due to the returned condition of the iab and unable to mimic the clinical settings.Additionally, the reported leak likely resulted from a condition known as ¿channeling¿.Arterial blood under pressure may run the length of the folds in the balloon membrane and drip or be expelled under arterial pressure from the balloon/catheter junction.This "channeling" is not a leak and will diminish as the iab catheter is inserted.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.The device meets all product specifications.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 the insertion of an intra-aortic balloon (iab), the customer saw blood and noticed the iab was punctured due to the balloon membrane not being wrapped tightly.A new iab was inserted successfully.There was no patient injury or adverse event reported.
 
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Brand Name
SENSATION PLUS 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 Key10537473
MDR Text Key208507170
Report Number2248146-2020-00471
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108605
UDI-Public10607567108605
Combination Product (y/n)N
PMA/PMN Number
K112327
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/14/2023
Device Model Number0684-00-0576-01
Device Catalogue Number0684-00-0575
Device Lot Number3000118913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Date Manufacturer Received10/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight82
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