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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problems Unraveled Material (1664); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/30/2020
Event Type  malfunction  
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 record id # (b)(4).
 
Event Description
It was reported during insertion of the intra-aortic balloon (iab), the balloon would not pass through the sheath and balloon was unwrapped.Another balloon was opened and utilized.There was no reported injury to the patient.
 
Event Description
It was reported during insertion of the intra-aortic balloon(iab), the balloon would not pass through the sheath and balloon was unwrapped.Another balloon was opened and utilized.There was no reported injury to the patient.
 
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 and syringe were also returned still attached to the extracorporeal tubing.A catheter tubing kink was observed at approximately 67.3cm from the iab tip.At this same location, an optical fiber break was also observed.The one-way valve was vacuum tested and it held vacuum.A laboratory insertion test was unable to be performed due to the returned condition of the iab.A 0.025¿ laboratory guidewire was inserted into the inner lumen and was found to be clear, no obstruction were felt.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The evaluation cannot confirm the reported problem due to the returned condition of the iab.We are unable to mimic the clinical settings.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.Reference complaint #(b)(4).
 
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Brand Name
SENSATION PLUS 8FR. 50CC
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key10075057
MDR Text Key196847526
Report Number2248146-2020-00259
Device Sequence Number1
Product Code DSP
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
Report Date 06/19/2020
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 Date12/09/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000110617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2020
Initial Date Manufacturer Received 05/04/2020
Initial Date FDA Received05/20/2020
Supplement Dates Manufacturer Received06/12/2020
Supplement Dates FDA Received06/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age71 YR
Patient Weight113
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