MAUDE Adverse Event Report: ST. JUDE MEDICAL REFLEXION¿ HD HIGH DENSITY CATHETER, 5 F LOOP BI-DIRECTIONAL, 99 CM LENGTH, SYMM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D402864

Device Problem Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

This report is to advise of a short circuit found during analysis.

Manufacturer Narrative

One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Electrode 6 displayed acceptable resistance values; however, a short circuit was detected between electrode 5 and conductor wires 1, 13 and 18.Dissection revealed no apparent wire damage or visible root cause for the short circuit detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the short circuit remains unknown.

• Brand Name: REFLEXION¿ HD HIGH DENSITY CATHETER, 5 F LOOP BI-DIRECTIONAL, 99 CM LENGTH, SYMM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15794898
• MDR Text Key: 307174528
• Report Number: 2182269-2022-00058
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734217262
• UDI-Public: 05414734217262
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D402864
• Device Catalogue Number: D402864
• Device Lot Number: 8381894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1