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

Model Number	D402893
Medical Device Problem Codes	Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
This report is to advise of an event observed during analysis revealed a detached electrode and exposed wires on the catheter.
Additional Manufacturer Narrative
Additional information: g4, h2, h3, h6; one duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Visual inspection of the spiral loop, a tear in the shaft and a detached electrode was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn shaft material and detached electrode is consistent with damage during use.

• Brand Name: REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER
• 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: 9289662
• Report Number: 2182269-2019-00195
• Device Sequence Number: 2362407
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: 05414734216654
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072012
• 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): 01/02/2020

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: 07/31/2021
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 6550828
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1