MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE; CATHETER, STEERABLE

Model Number	401914
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission.
Event or Problem Description
During a procedure the catheter was placed through vena femoralis into the right atrium.After pulling the catheter out of the patient it was noticed that tissue was at the tip of the catheter.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.There were no performance issues with any abbott device.
Additional Manufacturer Narrative
One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.No blood-like substance (bls) was seen on the returned device.Foreign material was noted on the distal tip of the catheter.No other visual anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the tissue on the tip of the catheter remains unknown.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8683617
• Report Number: 2182269-2019-00080
• Device Sequence Number: 16711511
• Product Code: DRA
• UDI-Device Identifier: 05414734202565
• UDI-Public: 05414734202565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K913940
• 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): 07/17/2019

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: 08/31/2021
• Device Model Number: 401914
• Device Catalogue Number: 401914
• Device Lot Number: 6584511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other