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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0567
Device Problems Device Inoperable (1663); Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2017
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.(b)(4).
 
Event Description
It was reported that after insertion of intra-aortic balloon (iab) therapy a fiber optic sensor failure alarm was generated.There was an attempt to reconnect the sensor multiple times but alarm continued.Changed console and the iab still did not work.Pressure line used instead of fiber optics, but damped frequently and had trouble flushing.There was no reported injury to the patient.
 
Manufacturer Narrative
Complaint # (b)(4).
 
Event Description
It was reported that after insertion of intra-aortic balloon (iab) therapy a fiber optic sensor failure alarm was generated.There was an attempt to reconnect the sensor multiple times but alarm continued.Changed console and the iab still did not work.Pressure line used instead of fiber optics, but damped frequently and had trouble flushing.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.One kink was found on the catheter tubing approximately 4.6cm from the iab tip.The optical fiber was found to be broken at this kinked location.The technician was able to successfully aspirate/flush the inner lumen.We were not able to confirm difficult/unable to flush.The optical fiber was found to be broken, confirming the alarm, fiber optic sensor failure.It is difficult to determine when or how a break in the fiber optic occurs.However, a kink in the catheter can cause the fiber optic to break resulting in no signal or the inability to calibrate it.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
 
Event Description
It was reported that after insertion of intra-aortic balloon (iab) therapy a fiber optic sensor failure alarm was generated.There was an attempt to reconnect the sensor multiple times but alarm continued.Changed console and the iab still did not work.Pressure line used instead of fiber optics, but damped frequently and had trouble flushing.There was no reported injury to the patient.
 
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Brand Name
SENSATION PLUS 7.5FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7003805
MDR Text Key92093637
Report Number2248146-2017-00614
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122628
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 02/07/2018
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 Date03/21/2019
Device Catalogue Number0684-00-0567
Device Lot Number3000026131
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 10/15/2017
Initial Date FDA Received11/06/2017
Supplement Dates Manufacturer Received11/29/2017
01/18/2018
Supplement Dates FDA Received12/22/2017
02/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age57 YR
Patient Weight80
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