MAUDE Adverse Event Report: ST. JUDE MEDICAL SUPREME ELECTROPHYSIOLOGY CATHETER, DECAPOLAR, 65 CM LENGTH, CSL CURVE, ELECTR; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 401864

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

One 5f, decapolar, csl, supreme ep catheter was received for evaluation.The catheter shaft was noted to be separated at the grey/black transition.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the separated shaft is consistent with damage during use.

Event Description

This report is to advise of an event observed during analysis confirming a exposed internal wiring on the catheter.

• Brand Name: SUPREME ELECTROPHYSIOLOGY CATHETER, DECAPOLAR, 65 CM LENGTH, CSL CURVE, ELECTR
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12294974
• MDR Text Key: 265620411
• Report Number: 3008452825-2021-00421
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734201544
• UDI-Public: 05414734201544
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K002976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 401864
• Device Catalogue Number: 401864
• Device Lot Number: 7737085
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• 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