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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0434
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/08/2017
Event Type  malfunction  
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. The returned sheath was over the catheter but it was not a maquet product. The extension tubing was also returned. Four kinks were observed on the catheter tubing approximately 52. 1cm, 52. 6cm, 52. 8cm and 76. 2cm from the iab tip. The optical fiber was also found to be broken at this location. The optical fiber was found to be broken, 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 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).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy there was a fiber optic sensor failure alarm generated. There was no reported injury to the patient.
 
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) therapy there was a fiber optic sensor failure alarm generated. There was no reported injury to the patient.
 
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Brand NameSENSATION 7FR. 40CC IAB
Type of DeviceSYSTEM, 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 Key7154850
MDR Text Key252105229
Report Number2248146-2017-00753
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/22/2020
Device Catalogue Number0684-00-0434
Device Lot Number3000056315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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