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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL SYSTEMS AB PRESSUREWIRE AERIS; GUIDEWIRE SENSOR
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ST JUDE MEDICAL SYSTEMS AB PRESSUREWIRE AERIS; GUIDEWIRE SENSOR Back to Search Results
Model Number C12058
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/23/2014
Event Type  malfunction  
Event Description
The physician was using the pressurewire aeris and the tip brok off in the pt.The pt is doing fine.
 
Manufacturer Narrative
The product has been returned to the mfr and is undergoing investigation.A review of the device history record confirmed that the device was manufactured according to sjm specification.
 
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Brand Name
PRESSUREWIRE AERIS
Type of Device
GUIDEWIRE SENSOR
Manufacturer (Section D)
ST JUDE MEDICAL SYSTEMS AB
palmbladsgatan 10
box - 6350
uppsala SE-75 1
SW  SE-751
Manufacturer Contact
emil anderas
palmbladsgatan 10
uppsala 35 SE-75-1
SW   SE-751
8161000
MDR Report Key4200034
MDR Text Key4966114
Report Number8030904-2014-00017
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/25/2014
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 Date05/30/2016
Device Model NumberC12058
Device Lot Number4664966
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
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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