MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION SPIRAL¿ VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	402804
Medical Device Problem Codes	Material Frayed (1262); Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission. .
Event or Problem Description
During the procedure, the catheter was inserted into the left atrium and the chamber was mapped.The catheter was maneuvered to the left superior pulmonary vein but appeared stuck and unable to move.The catheter was manipulated and removed from the patient and visual inspection revealed an exposed catheter wiring and frayed outer material.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The reported damage and deflection issue could not be confirmed.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 frayed and exposed internal components could not be conclusively determined.

• Brand Name: REFLEXION SPIRAL¿ VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9304378
• Report Number: 2182269-2019-00236
• Device Sequence Number: 1724427
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K062251
• 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): 12/04/2019

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: 03/31/2022
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 6957671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1