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

Device Problem Signal Artifact/Noise (1036)

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

Event Date 04/08/2022

Event Type  malfunction  

Event 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.

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.

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
• 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: 14319759
• MDR Text Key: 292159986
• Report Number: 3008452825-2022-00410
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734200899
• UDI-Public: 05414734200899
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K894500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• 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
• Treatment: INQUIRY¿ AFOCUS LL¿ DIAGNOSTIC CATHETER