MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number	401582
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
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
During the procedure, an unknown soft, floppy structure was noted at the tip of the catheter upon removal from the patient.The catheter was introduced to the right atrium via the groin and would not advance to the coronary sinus.Upon removal, a soft, floppy structure was observed at the tip of the catheter.The catheter was replaced to continue the procedure no adverse consequences to the patient.
Additional Manufacturer Narrative
One 7f, decapolar, medium sweep, livewire ep catheter was received for evaluation.Foreign material resembling tissue was noted on the distal tip of the catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fm on the distal tip is consistent with usage of the device.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 10777785
• Report Number: 2182269-2020-00095
• Device Sequence Number: 1061552
• Product Code: DRA
• UDI-Device Identifier: 05414734202251
• UDI-Public: 05414734202251
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K022380
• 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
• Report Date (Section B): 12/16/2020

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: 02/28/2023
• Device Model Number: 401582
• Device Catalogue Number: 401582
• Device Lot Number: 7451531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1