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

Model Number	401353
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a premature ventricular contraction ablation procedure, the catheter was noted to have exposed wiring.The device was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 6f, decapolar, csl, response ep catheter was received for evaluation.Visual inspection showed that the shaft was fractured 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 fractured shaft is consistent with damage during use.

• Brand Name: RESPONSE ELECTROPHYSIOLOGY CATHETER, DECAPOLAR, 65 CM LENGTH, CSL CURVE, ELECT
• 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: 11502785
• Report Number: 3008452825-2021-00156
• Device Sequence Number: 4087789
• Product Code: DRF
• UDI-Device Identifier: 05414734200899
• UDI-Public: 05414734200899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K894500
• 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,Followup
• Report Date (Section B): 08/06/2021

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: 01/31/2023
• Device Model Number: 401353
• Device Catalogue Number: 401353
• Device Lot Number: 7416851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1