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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC EVEREST INFLATION DEVICE 30ATM; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

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MEDTRONIC, INC EVEREST INFLATION DEVICE 30ATM; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number AC3200
Device Problems Leak/Splash (1354); Improper Device Output (2953)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2017
Event Type  malfunction  
Event Description
An everest device was being used during a procedure to treat a lesion in the renal artery.The device was removed from packaging, inspected and prepped per ifu with no issues noted.During use there was a manometer issue.The pressure was applied up to 30 atm, and the piston was locked.However, the pressure gauge indicated that the pressure was decreasing.The everest was connected to a balloon and a three-way stopcock.No injury reported.
 
Manufacturer Narrative
The everest was received with fluid in the syringe body.The stop cock from the everest kit and mating devices used in the case were returned for analysis with the inflation device.The everest was connected to the stopcock and the stopcock to one of the non-mdt 6.0x40mm balloon luer.As received the gauge needle is at -0 atm-, the plunger was pulled back and the needle returned to red as required.The everest syringe body, tube and lure rotator/connector all appear undamaged and without defect.The connections were taken apart and pressure/inflation function was tested on the returned everest inflation device and the device failed to hold pressure.A leak was detected during pressure testing, water exited the syringe thru cracks on the syringe threads.The needle moved normally while pressure was applied, but due to the detected leak the pressure was decreasing.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
EVEREST INFLATION DEVICE 30ATM
Type of Device
ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer (Section G)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6571615
MDR Text Key75309339
Report Number1220452-2017-00046
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K960983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 07/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/09/2018
Device Catalogue NumberAC3200
Device Lot Number50990364
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/18/2017
Initial Date FDA Received05/17/2017
Supplement Dates Manufacturer Received06/05/2017
07/12/2017
07/12/2017
Supplement Dates FDA Received07/05/2017
08/11/2017
09/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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