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

Catalog Number IBI-87008

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2016

Event Type  malfunction  

Event Description

During a radio frequency ablation, the st.Jude medical catheter tip malfunctioned.The tip locked tightly and would not bend and could not be maneuvered.There were multiple attempts made without success.

• Type of Device: CATHETER, ELECTRODE RECORDING,
• Manufacturer (Section D): ST. JUDE MEDICAL; medical one st. jude drive; st paul MN 55117
• MDR Report Key: 5440809
• MDR Text Key: 38309100
• Report Number: 5440809
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: IBI-87008
• Device Lot Number: 5183440
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Age: 79 YR