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 Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned due to an insertion and signal issue.Visual inspection revealed a fracture at the spiral loop/shaft transition, consistent with the reported insertion issue.Electrodes 1-20 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the shaft damage is consistent with damage during use.The cause of the reported signal issue remains unknown.
Event or Problem Description
This report is to advise of an event observed during analysis, confirming a shaft fracture on the catheter.

• 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: 10454297
• Report Number: 2182269-2020-00074
• Device Sequence Number: 11431880
• Product Code: DRF
• UDI-Device Identifier: 05414734216654
• UDI-Public: 05414734216654
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

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: 03/31/2023
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 7446895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1