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	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 2030404-2022-00037.During the supraventricular tachycardia procedure, interference was noted which caused a delay.Signal interference was noted during the procedure and the fourth electrode appeared distorted in the system.After multiple attempts of catheter introduction and withdrawal, the catheter still appeared distorted in the system.Another catheter was used which had the same issue.A third catheter was used to continue the procedure, however this caused a delay.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported noise and subsequent delay remain unknown.
Additional Manufacturer Narrative
Additional information d9, g3, h2, h3, h6 one 6f, decapolar, csl, response ep catheter was received for evaluation.Electrodes 1-10 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported noise and subsequent delay remains unknown.

• 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
• 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: 14319759
• Report Number: 3008452825-2022-00410
• Device Sequence Number: 4891023
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 401353
• Device Catalogue Number: 401353
• Device Lot Number: 8070362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/17/2022; 08/17/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/23/2022; 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INQUIRY¿ AFOCUS LL¿ DIAGNOSTIC CATHETER
• Patient Sex: Unknown