ULTRAWAND LP 12400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2009-11-04 for ULTRAWAND LP 12400 manufactured by St. Jude Medical.

Event Text Entries

[1254231] It was reported the ultrawand device was used during cardiac tissue ablation and a "popping" noise occurred. The surgeon noted that the ultrawand was very "hot" and was concerned about over heating. The epicardial tissue was the source of "popping" noise. There were no reported patient consequences.
Patient Sequence No: 1, Text Type: D, B5


[8324182] The device was not returned for evaluation. However, review of the device history record confirmed this device met manufacturing requirements prior to shipment. Animal studies have demonstrated that audible saline boiling (popping sound) can occur if any cell loses contact with the tissue during ablation, and has not resulted in tissue damage. Audible saline boiling can also occur if the wand is pressed too hard against the tissue, which slows or stops the flow of saline through one or both cells and results in conductive tissue heating. There were no reported consequences to the patient. A precaution has been added to the epicor ultrawand lp instructions for use (ifu) that states "applying excessive pressure to the device may temporarily decrease saline flow by collapsing or blocking the saline irrigation membranes, resulting in a decrease of acoustic coupling and an increase in heat conducted from the ablation array.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003870001-2009-00013
MDR Report Key1542350
Report Source05,06,07
Date Received2009-11-04
Date of Report2009-11-04
Date of Event2009-04-16
Date Facility Aware2009-04-16
Date Mfgr Received2009-05-01
Device Manufacturer Date2008-10-02
Date Added to Maude2010-01-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactKAREN MCKELVEY
Manufacturer StreetONE ST. JUDE MEDICAL DRIVE
Manufacturer CityST. PAUL MN 55117
Manufacturer CountryUS
Manufacturer Postal55117
Manufacturer Phone6517562000
Manufacturer G1ST. JUDE MEDICAL
Manufacturer Street240 SANTA ANA COURT
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRAWAND LP
Generic NameULTRAWAND LP
Product CodeNTB
Date Received2009-11-04
Model NumberNA
Catalog Number12400
Lot NumberNA
Device Expiration Date2009-10-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer AddressSUNNYVALE CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-11-04

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