MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Lot Number 4033942

Device Problems Defective Component (2292); Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Defective reflexion spiral catheter.Once deflected, the catheter would not close properly when the physician tried closing it.

• Brand Name: REFLEXION
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st jude medical dr; st paul MN 55117
• MDR Report Key: 3861475
• MDR Text Key: 4682738
• Report Number: 3861475
• 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
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 4033942
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR