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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, the catheter did not steer accurately.The catheter was removed and the insulation of the catheter was separated with exposed internal components.The catheter was replaced and the procedure was continued with no adverse consequences to the patient.
Event or Problem Description
The physician used a straightener that was in the catheter to pass through the sheath.There were no insertion difficulties noted.
Additional Manufacturer Narrative
One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.The catheter did not meet specifications for curve deflection in either direction due to the fracture in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured shaft is consistent with damage during use.

• 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: 7873783
• Report Number: 2182269-2018-00114
• Device Sequence Number: 1566864
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K072012
• 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,Followup
• Report Date (Section B): 03/14/2019

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: 07/31/2020
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 6096268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 03/01/2019
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/10/2018; 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR