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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number D-AVHD-DF16
Device Problems Fracture (1260); Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
Visual inspection of the paddle revealed a number of locations with surface damage on the paddle splines.Electrodes 1, 6, 14 and 16 read as open circuits.Dissection revealed conductor wires 1, 6, 14 and 16 had been fractured proximal to the weld joints, consistent with the open circuits detected and the reported signal issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured conductor wires and paddle damage is consistent with damage during use.
 
Event Description
This report is to advise of an event of a shaft tear observed during analysis, confirming the reported noise issue.
 
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Brand Name
ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie o' sullivan
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key8314697
MDR Text Key135354175
Report Number3005334138-2019-00059
Device Sequence Number1
Product Code DRF
UDI-Device Identifier05415067028198
UDI-Public05415067028198
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 02/07/2019
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 Date08/31/2019
Device Model NumberD-AVHD-DF16
Device Lot Number6437614
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/31/2019
Initial Date FDA Received02/07/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/02/2018
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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