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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0433
Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/03/2018
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.(b)(4).
 
Event Description
It was reported that prior to intra-aortic balloon (iab) therapy, as the guide wire was inserted, it presented a kink which impeded the advancement of the iab.The indication for use was ventricular failure.A new iab was used to continue therapy.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 prior to intra-aortic balloon (iab) therapy as the guide wire was inserted it presented a kink which impeded the advancement of the iab.The indication for use was ventricular failure.A new iab was used to continue therapy.There was no reported injury to the patient.
 
Manufacturer Narrative
The product was returned with the membrane loosely folded and no visible blood on the catheter.The extender tubing and insertion kit was also returned.An inner lumen kink was observed 52.8cm from iab tip.The optical fiber was found to be broken at the kinked location.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The technician attempted to insert a 0.018¿ laboratory guide wire through the inner lumen and blockage was only felt at the kinked location.The condition of the iab as received indicated a kink on the inner lumen.We are unable to determine when the kink may have occurred.Kinks on the inner lumen can cause difficulty during guide wire insertion.The evaluation confirmed the reported problem.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.(b)(4).
 
Event Description
It was reported that prior to intra-aortic balloon (iab) therapy as the guide wire was inserted it presented a kink which impeded the advancement of the iab.The indication for use was ventricular failure.A new iab was used to continue therapy.There was no reported injury to the patient.
 
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Brand Name
SENSATION 7FR. 34CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8038649
MDR Text Key126715303
Report Number2248146-2018-00630
Device Sequence Number0
Product Code DSP
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/09/2021
Device Catalogue Number0684-00-0433
Device Lot Number3000073084
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Device AgeYR
Initial Date Manufacturer Received 10/11/2018
Initial Date FDA Received11/05/2018
Supplement Dates Manufacturer Received11/19/2018
12/12/2018
Supplement Dates FDA Received12/11/2018
12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
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