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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 Problems Difficult to Insert (1316); Sticking (1597)
Patient Problems Death (1802); Ventricular Fibrillation (2130); Vascular Dissection (3160)
Event Date 12/03/2015
Event Type  Death  
Manufacturer Narrative
(b)(4). The device has not yet been returned to maquet for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received. 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
This complaint is for the third iab inserted. No reported malfunction. Aortic dissection discovered and patient death. Following an elective cabg procedure, a (b)(6) yo male patient experienced vf. During insertion of a sensation plus 50 cc iab, the balloon became stuck in the sheath and could not be inserted. The sheath was left in place and a second balloon was prepped and insertion attempted. Proper prep was employed, with vacuum applied to the one way valve. This second attempt did not work, and the balloon would not pass through the sheath. A 9 french sheath was obtained and inserted and then a 3rd balloon was inserted successfully. The patient was experiencing vf at the time of these insertions, post cabg. Patient was then transferred to the icu. Later that evening, it was discovered that the patient had a dissection in the external iliac region just before the internal iliac take off on the right side. The balloon was removed and the patient returned to the cath lab where a stent procedure was done to repair the dissection. The patient was then returned to the icu. Additional info/possible batch provided on 14-dec-2015.
 
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Brand NameSENSATION PLUS 8FR. 50CC 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 Key5341497
MDR Text Key34976012
Report Number2248146-2016-00001
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133074
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 12/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0684-00-0575
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received12/09/2015
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/04/2016 Patient Sequence Number: 1
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