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

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

This report is to advise of an event observed during analysis revealed a detached electrode and exposed wires on the catheter.

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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9289662
• MDR Text Key: 179107581
• Report Number: 2182269-2019-00195
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: 05414734216654
• Combination Product (y/n): N
• PMA/PMN Number: K072012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1