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

Model Number	401434
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in the final report.
Event or Problem Description
During a procedure, the catheter fractured at the black to gray transition of the shaft during manipulation, exposing internal components.The catheter was replaced to finish the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
One supreme¿ electrophysiology catheter was returned for investigation.The reported shaft damage was confirmed.The shaft of the catheter was noted to be separated between the grey and black braided shaft portion due to an inefficient bonding technique.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE
• 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: 8566619
• Report Number: 3008452825-2019-00221
• Device Sequence Number: 2074927
• Product Code: DRF
• UDI-Device Identifier: 05414734201308
• UDI-Public: 05414734201308
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K894500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 401434
• Device Lot Number: 6342729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1