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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 Problems Material Rupture (1546); Device Displays Incorrect Message (2591)
Patient Problems Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969)
Event Date 03/21/2018
Event Type  Death  
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. Complaint # (b)(4).
 
Event Description
It was reported there was an intra-aortic balloon (iab) rupture during iab therapy. There was blood in the tubing and alarm 'augmentation below limit set' generated. The patient was intubated and put on pressors (blood pressure agents). The indication for use was nstemi (non-st-elevation myocardial infarction). The customer stated that the patient had a stroke. It was then reported that the patient expired on (b)(6) 2018.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter. The extender tubing was also returned. One kink was found on the catheter tubing near the y-fitting approximately 76. 2 cm from the iab tip. The optical fiber was found to be broken at this location. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and one leak was detected on the membrane approximately 1 cm from the rear seal measuring 0. 025 cm in length. The reported alarm 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 problem. 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 there was an intra-aortic balloon (iab) rupture during iab therapy. There was blood in the tubing and alarm 'augmentation below limit set' generated. The patient was intubated and put on pressors (blood pressure agents). The indication for use was nstemi (non-st-elevation myocardial infarction). The customer stated that the patient had a stroke. It was then reported that the patient expired on (b)(6) 2018.
 
Manufacturer Narrative
(b)(4). Complaint # (b)(4), record # (b)(4).
 
Event Description
It was reported there was an intra-aortic balloon (iab) rupture during iab therapy. There was blood in the tubing and alarm 'augmentation below limit set' generated. The patient was intubated and put on pressors (blood pressure agents). The indication for use was nstemi (non-st-elevation myocardial infarction). The customer stated that the patient had a stroke. It was then reported that the patient expired on (b)(6) 2018.
 
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Brand NameSENSATION PLUS 7.5FR. 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 Key7431747
MDR Text Key105503790
Report Number2248146-2018-00253
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Catalogue Number0684-00-0567
Device Lot Number3000063088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received05/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/14/2018 Patient Sequence Number: 1
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