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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0475
Device Problem Fluid Leak (1250)
Patient Problems Death (1802); Failure of Implant (1924)
Event Date 08/12/2017
Event Type  Death  
Manufacturer Narrative
The product was returned with the membrane loosely folded and blood found on the exterior of the catheter. The technician was able to successfully aspirate/flush the inner lumen. The technician attempted to insert the returned 0. 025¿ guide wire through the inner lumen and was able to successfully insert the guide wire. No obstructions were felt. An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no leaks were detected. The iab was placed on the cs300 pump and the iab fully inflated. No alarm sounded from the pump. The evaluation of the returned iab included functional tests and visual inspections. No abnormalities were found. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. 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 by the facility that an event occurred on (b)(6) 2017 involving the intra-aortic balloon (iab). A linear iab was inserted through the femoral sheath on (b)(6) 2017 into a patient in cardiogenic shock, mi, and that had poor ef. It was noted that during insertion of the iab over the guidewire that blood was found to be leaking from the center of the balloon. The balloon was removed and found to be filled with blood. The iab was replaced however the patient expired on (b)(6) 2017. This report is for the second balloon where there was no reported malfunction.
 
Event Description
It was reported by the facility that an event occurred on (b)(6) 2017 involving the intra-aortic balloon (iab). A linear iab was inserted through the femoral sheath on (b)(6) 2017 into a patient in cardiogenic shock, mi, and that had poor ef. It was noted that during insertion of the iab over the guidewire that blood was found to be leaking from the center of the balloon. The balloon was removed and found to be filled with blood. The iab was replaced however the patient expired on (b)(6) 2017. This report is for the second balloon where there was no reported malfunction.
 
Manufacturer Narrative
(b)(4). 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. We continue our efforts to follow up with the customer for its return. (b)(4).
 
Event Description
It was reported by the facility that an event occurred on (b)(6) 2017 involving the intra-aortic balloon (iab). A linear iab was inserted through the femoral sheath on (b)(6) 2017 into a patient in cardiogenic shock, mi, and that had poor ef. It was noted that during insertion of the iab over the guidewire that blood was found to be leaking from the center of the balloon. The balloon was removed and found to be filled with blood. The iab was replaced however the patient expired on (b)(6) 2017. This report is for the second balloon where there was no reported malfunction.
 
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Brand NameLINEAR 7.5 FR. 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 Key6843567
MDR Text Key105964124
Report Number2248146-2017-00372
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/24/2019
Device Catalogue Number0684-00-0475
Device Lot Number3000031724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received11/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2016
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: 09/05/2017 Patient Sequence Number: 1
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