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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 Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
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 # (b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy, a "check iab catheter" alarm was received during initial femoral insertion of a sensation plus 50cc iab.The pump was switched to another pump, with the same "check iab catheter alarm" on the second pump.The iab was removed and a second sensation plus 50cc iab was placed without incident, although the customer noted that the tip of the initial iab on fluoroscopy may have been above the subclavian artery, so the second iab was placed below the subclavian artery.The second iab worked as expected with no alarms reported.There were no reported consequences or impact to the patient.
 
Manufacturer Narrative
Corrected section: e3 - 'occupation' - changed from other to other health professional.The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.One kink was found on the catheter tubing near the y-fitting approximately 75.4cm from the iab tip.Inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The evaluation determined there was a kink in the catheter.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.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.Complaint record #: (b)(4).
 
Event Description
It was reported during intra-aortic balloon (iab) therapy, a "check iab catheter" alarm was received during initial femoral insertion of a sensation plus 50cc iab.The pump was switched to another pump, with the same "check iab catheter alarm" on the second pump.The iab was removed and a second sensation plus 50cc iab was placed without incident, although the customer noted that the tip of the initial iab on fluoroscopy may have been above the subclavian artery, so the second iab was placed below the subclavian artery.The second iab worked as expected with no alarms reported.There were no reported consequences or impact to the patient.
 
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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 Key9661059
MDR Text Key187911007
Report Number2248146-2020-00063
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 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/17/2022
Device Catalogue Number0684-00-0575
Device Lot Number3000106672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
Patient Weight98
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