ULTRAWAND LP UW-LP-2 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-27 for ULTRAWAND LP UW-LP-2 * manufactured by St. Jude Medical, Inc..

Event Text Entries

[1161865] An ultrawand catheter was put on the field for a maze procedure. When the catheter was connected to the epicor machine it was not recognized as a proper connection. After reattaching many times we changed ultrawand catheter. A second catheter was connected without problems. The device had no contact with the patient; it was found to be malfunctioning before use. The epicor machine has a built in safety feature. No patient sequelae. The lot number could not be found on the packaging; device and packaging returned to manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1403065
• MDR Report Key: 1403065
• Date Received: 2009-05-27
• Date of Report: 2009-05-27
• Date of Event: 2009-05-20
• Report Date: 2009-05-27
• Date Reported to FDA: 2009-05-27
• Date Added to Maude: 2009-06-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ULTRAWAND LP
• Generic Name: CATHETER, ABLATION, CARDIAC
• Product Code: NTB
• Date Received: 2009-05-27
• Returned To Mfg: 2009-06-03
• Model Number: UW-LP-2
• Catalog Number: *
• Lot Number: NONE ON PACKAGING
• ID Number: *
• Operator: NURSE
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL, INC.
• Manufacturer Address: DIRECTOR REGULATORY AFFIARS 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-05-27