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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0575
Device Problem Gas/Air Leak (2946)
Patient Problems Myocardial Infarction (1969); Rupture (2208); Cardiogenic Shock (2262)
Event Date 02/19/2018
Event Type  Injury  
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.Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) use there was blood noted in the iab as well as tubing.At the insertion site, while the iab was in the sheath, leaking was noted as there was a gas hissing noise.The customer stated a vessel rupture occurred.The patient experienced a severe hemorrhage which required a surgical intervention.The indication for use was cardiogenic shock/st-elevation myocardial infarction (stemi).
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extender and pressure tubing were also returned.Inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and one leak was detected on the membrane approximately 1.3cm from the rear seal measuring 0.025cm in length.The reported problems was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.The evaluation confirmed the reported problems.An abrasion leak is a known inherent risk and common failure mode caused by calcified plaque in the aorta.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 during intra-aortic balloon (iab) use there was blood noted in the iab as well as tubing.At the insertion site, while the iab was in the sheath, leaking was noted as there was a gas hissing noise.The customer stated a vessel rupture occurred.The patient experienced a severe hemorrhage which required a surgical intervention.The indication for use was cardiogenic shock/st-elevation myocardial infarction (stemi).
 
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) use there was blood noted in the iab as well as tubing.At the insertion site, while the iab was in the sheath, leaking was noted as there was a gas hissing noise.The customer stated a vessel rupture occurred.The patient experienced a severe hemorrhage which required a surgical intervention.The indication for use was cardiogenic shock/st-elevation myocardial infarction (stemi).
 
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Brand Name
SENSATION PLUS 8FR. 50CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key7687563
MDR Text Key114001278
Report Number2248146-2018-00443
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112327
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 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/14/2020
Device Catalogue Number0684-00-0575
Device Lot Number3000055410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2018
Device Age YR
Date Manufacturer Received08/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Weight72
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