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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problem Folded (2630)
Patient Problems Death (1802); Myocardial Infarction (1969)
Event Date 01/30/2018
Event Type  Death  
Manufacturer Narrative
Dealer - (b)(4). The device was not returned and could not be evaluated. It was discarded by the user. We are unable to confirm the reported event. If new information becomes available, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) insertion upon opening of the iab, there was a fold found on the catheter. The customer noted it seemed to be related to the catheter shaft. The iab was replaced. The indication for use was ami (acute myocardial infarction). The patient died because of heart disease after iab therapy, but the death was not attributed to the device by the facility. The date of death was (b)(6) 2018. This submission is for the 2nd iab used where there was no reported malfunction.
 
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Brand NameLINEAR 7.5 FR. 34CC 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 Key7289644
MDR Text Key100709641
Report Number2248146-2018-00116
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0474
Device Lot NumberUNKNOWN
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 Received01/31/2018
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: 02/22/2018 Patient Sequence Number: 1
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