MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE ARRAY; CATHETER, ELECTRODE RECORDING

Model Number EC1000-204

Device Problems Failure to Advance (2524); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Array catheter was prepped properly but was found to be defective when the protective sleeve was unable to be advanced over the array catheter.Catheter was not used on the patient.

• Brand Name: ENSITE ARRAY
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; one st jude medical drive; st paul MN 55117
• MDR Report Key: 3649565
• MDR Text Key: 4347680
• Report Number: 3649565
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: EC1000-204
• Device Lot Number: 4231622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1