ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9 12544

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-11-10 for ULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9 12544 manufactured by St. Jude Medical.

Event Text Entries

[1807783] It was reported during ablation, the physician noticed that the plastic sleeve around the electrical cable and rinsing tubes disconnected from the cinch. The proximal connector moved below the svc so after complete ablation, the electrical cable had to be cut ro remove the ultracinch device. There were no consequences to the pt.
Patient Sequence No: 1, Text Type: D, B5


[8906725] We are awaiting device return. When our investigation has been completed, a follow up report will be submitted. Date report submitted to fda by manufacturer: (b)(4) 2010. Date the initial reporter provided the information to the manufacturer: (b)(4) 2010.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003870001-2010-00013
MDR Report Key1907130
Report Source01,05,06,07
Date Received2010-11-10
Date of Report2010-10-14
Date of Event2010-10-14
Date Mfgr Received2010-10-14
Date Added to Maude2011-06-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactSETH KERSTEN
Manufacturer StreetONE ST. JUDE MEDICAL DR
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 NameULTRACINCH LP, DEPLOYABLE TISSUE ABLATION, UC-LP-9
Generic NameUC-LP-9
Product CodeNTB
Date Received2010-11-10
Model Number12544
Catalog Number12544
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer AddressSUNNYVALE CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2010-11-10

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