MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ELECTRODE RECORDING CATHETER; CATHETER, STEERABLE

Model Number	401575
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
During a 3d mapping procedure, the catheter became lodged in a small branch off the right femoral vein and could not be removed.Other catheters were successfully introduced and the procedure was completed successfully.At end of case, the catheter was still lodged in the vein.Glyceryl trinitrate was given to relax the veins and with some force, the catheter was removed.Inspection of the device revealed tissue on the catheter tip.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported withdrawal difficulties and tissue on the tip remains unknown.

• Brand Name: ELECTRODE RECORDING CATHETER
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8951034
• Report Number: 2182269-2019-00130
• Device Sequence Number: 2657784
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/10/2019

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: 02/28/2022
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 6789424
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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