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

Model Number	D402893
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2182269-2018-00105.During the procedure, noise was noted on the distal pair of electrodes.Troubleshooting including changing the pinbox and replacing the connecting cable but the noise remained.The catheter was replaced and the same issue occurred, but the noise eventually resolved spontaneously.There was a clinically significant delay during the procedure to troubleshoot, but the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One reflexion spiral catheter was received for evaluation.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 reported noise remains unknown.

• Brand Name: REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 7790706
• Report Number: 2182269-2018-00104
• Device Sequence Number: 11142429
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: D402893
• Device Catalogue Number: D402893
• Device Lot Number: 6309640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REFLEXION SPIRAL CATHETER