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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 Positioning Problem (3009)
Patient Problems Death (1802); Great Vessel Perforation (2152)
Event Date 10/09/2016
Event Type  Death  
Manufacturer Narrative
The facility has indicated that the device is not available to return for evaluation, so we are unable to confirm the event. A review of the reported event has determined that the product was not used in accordance with the ifu which indicates that the iab catheter should be inserted through the femoral artery. A device and lot history record review and trend evaluation was completed for the reported product/event. No nonconformances were found that are considered to be related to the event. The customer indicated that the product is not returning to the manufacturer and we will be unable to complete an evaluation of the affected product. If additional information is supplied we will send a supplemental report with our additional findings. (b)(4).
 
Event Description
It was reported that there was a failure to introduce the iab catheter vessel dilator and femoral sheath with the guidewire through the thigh tissue of the patient. The doctor then inserted it through the ascending aorta and the balloon perforated the posterior wall of the aorta into the pleura. The patient required repair of the aortic arch perforation, which was performed during cabg. The patient was reported to have expired.
 
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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
MDR Report Key6075537
MDR Text Key59043208
Report Number2248146-2016-00088
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K041281
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 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0684-00-0474
Device Lot Number3078
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
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: 11/03/2016 Patient Sequence Number: 1
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