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

Model Number	401450
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a procedure, the catheter would not advance correctly and was prolapsing.When the catheter was removed, it was noted the catheter was kinked and some of the coating was peeling up.The catheter was replaced to complete the procedure with no patient consequences.
Additional Manufacturer Narrative
One supreme¿ electrophysiology catheter was received for investigation.The reported shaft damage was confirmed.Further investigation found that the separation in the shaft was due to insufficient bonding between the grey and black portions of the braided shaft.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, JSN 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: 10204356
• Report Number: 3008452825-2020-00328
• Device Sequence Number: 11337168
• Product Code: DRF
• UDI-Device Identifier: 05414734201421
• UDI-Public: 05414734201421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K002976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: 12/31/2022
• Device Model Number: 401450
• Device Catalogue Number: 401450
• Device Lot Number: 7335434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/27/2020
• Supplement Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 64