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
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 12294974
• Report Number: 3008452825-2021-00421
• Device Sequence Number: 14487336
• Product Code: DRF
• UDI-Device Identifier: 05414734201544
• UDI-Public: 05414734201544
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K002976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 401864
• Device Catalogue Number: 401864
• Device Lot Number: 7737085
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1