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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 Problem Occlusion Within Device (1423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2017
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 during intra-aortic balloon (iab) catheter therapy that the fiber optic cable stopped working immediately after insertion in the ccl.The radial arterial line was used for alternate as the central lumen was clotted.There was no injury or harm to the patient.
 
Manufacturer Narrative
09/08/2017 (b)(4): the product was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.One kink was found on the catheter tubing near the middle approximately 35.8cm from the iab tip.One kink was found on the catheter tubing near the y-fitting approximately 74.9cm from the iab tip.The optical fiber was found to be broken at this location.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen and resistance was only felt at the kinked location near the y-fitting approximately 74.9cm from the iab tip.The optical fiber was found to be broken and the inner lumen and catheter tubing kinked, confirming the reported problems.The evaluation confirmed the reported problem.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 kink in the inner lumen can also cause poor or no pressure waveform and guide wire insertion difficulty.Blood may clot in the inner lumen during use if a continual flush is not maintained.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.Complaint # (b)(4); record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) catheter therapy that the fiber optic cable stopped working immediately after insertion in the ccl.The radial arterial line was used for alternate as the central lumen was clotted.There was no injury or harm to the patient.
 
Manufacturer Narrative
(b)(4).Date received by manufacturer from 08/01/2017 to 09/06/2017 to reflect the most recent aware date.
 
Event Description
It was reported that during intra-aortic balloon (iab) catheter therapy that the fiber optic cable stopped working immediately after insertion in the ccl.The radial arterial line was used for alternate as the central lumen was clotted.There was no injury or harm 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 Key6812002
MDR Text Key83532675
Report Number2248146-2017-00320
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 Other
Type of Report Initial,Followup,Followup
Report Date 09/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date06/27/2019
Device Catalogue Number0684-00-0567
Device Lot Number3000031979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2017
Is the Reporter a Health Professional? No
Device AgeYR
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2016
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 Age68 YR
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