MAUDE Adverse Event Report: ST. JUDE MEDICAL RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, EL; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401210
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia procedure, it was noted that the connection of the black shaft of the electrode and the gray curved head was fractured on the diagnostic catheter.There was resistance when removing the catheter from the sheath.The catheter was not reinserted into the patient again after this issue was noted.The procedure was successfully completed with no adverse patient consequences.
Additional Manufacturer Narrative
One 6f, quadripolar, crd, response ep catheter was received for evaluation.One image was also submitted to product performance engineering for evaluation.The shaft of the catheter shaft was noted to be torn at the gray/black shaft bond joint.Internal wires were exposed.Bends were noted 5.1", 7.0" and 9.9" proximal to the distal tip.No other visual anomalies were noted.The removal difficulty could not be functionally tested due to the aforementioned damage.The cause of the removal difficulty could not be determined.The reported damage issue will continue to be monitored.

• Brand Name: RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, EL
• 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: 19131396
• Report Number: 3008452825-2024-00199
• Device Sequence Number: 4682882
• Product Code: DRF
• UDI-Device Identifier: 05414734200486
• UDI-Public: (01)05414734200486(10)9052082(17)260430
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 04/30/2026
• Device Model Number: 401210
• Device Lot Number: 9052082
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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
• Patient Sex: Unknown