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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 Problems Inflation Problem (1310); Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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 by the customer that when the intra-aortic balloon (iab) catheter kit was opened, the guide wire associated with the kit was defective.The customer stated that the guide wire which was in individual packaging had no issue.After the iab is inserted the connection is established with the ciphers, but the catheter did not function properly.The iab did not inflate, therefore a second catheter was opened and used.The same issue was encountered with the new replacement iab.The iab could not be used with the fiber optic pressure feature and ekg (electrocardiogram) probes were attached.The catheter did not work properly and could not get enough efficiency.This negativity has caused the hyperpulse to prolong the duration of the problem caused by the process lasting for a duration of 10 minutes - 72 minutes.The patient was assisted with only ekg signal trigger, augmentation was at max but iab still would not inflate fully.There was no injury reported to the patient.This report is for the second iab used.
 
Event Description
It was reported by the customer that when the intra-aortic balloon (iab) catheter kit was opened, the guide wire associated with the kit was defective.The customer stated that the guide wire which was in individual packaging had no issue.After the iab is inserted the connection is established with the ciphers, but the catheter did not function properly.The iab did not inflate, therefore a second catheter was opened and used.The same issue was encountered with the new replacement iab.The iab could not be used with the fiber optic pressure feature and ekg (electrocardiogram) probes were attached.The catheter did not work properly and could not get enough efficiency.This negativity has caused the hyperpulse to prolong the duration of the problem caused by the process lasting for a duration of 10 minutes - 72 minutes.The patient was assisted with only ekg signal trigger, augmentation was at max but iab still would not inflate fully.There was no injury reported to the patient.This report is for the second iab used.
 
Manufacturer Narrative
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 extender tubing was also returned.Three kinks were found on the catheter tubing approximately 47cm, 74.2cm and 75.9cm from the iab tip.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.A sensor output test was performed and the sensor was found to be within specification.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The iab was placed on the cs300 pump and the iab fully inflated.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.We were unable to duplicate the reported problem.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.We were unable to confirm the reported alarm, no pressure source & sensor failure.(b)(4).
 
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Brand Name
SENSATION 7FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7394101
MDR Text Key104422731
Report Number2248146-2018-00233
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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
Report Date 05/08/2018
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 Date06/08/2020
Device Catalogue Number0684-00-0434
Device Lot Number3000053159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2018
Device AgeYR
Initial Date Manufacturer Received 03/09/2018
Initial Date FDA Received04/03/2018
Supplement Dates Manufacturer Received04/17/2018
Supplement Dates FDA Received05/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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