MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

Device Problem Entrapment of Device (1212)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

An event of entrapment of the device was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Additionally, no lot number was provided so a review of the device history record (dhr) was not possible.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following was published in elsevier inc., titled, "entrapment of a steerable diagnostic electrophysiologic catheter in the thebesian valve during radiofrequency catheter ablation for atrial fibrillation" by euijae lee, et al.: ".To place the duodecapolar catheter on the lower ra and cs, we advanced the catheter into the mid-ra.The shaft of the catheter was bent and rotated counterclockwise.The tip of the catheter was directed to the ostium of the cs several times, but unexpected resistance was encountered during catheter manipulation.Further clockwise rotation attempts and forceful retraction failed to release the catheter.Intracardiac echocardiography (ice) revealed that the tip of the catheter touched interatrial septum without chiari network or tricuspid valve damage.We pulled the entrapped catheter with counterforce using a combination of a decapolar catheter and long sheath, but the catheter was not released.Finally, we cut the handle of the catheter, and the sl1 sheath was introduced over the catheter.We tried to detach the duodecapolar catheter into the sl1 sheath, but this maneuver also failed.We finally decided to perform open heart surgery to remove the catheter and a cox maze operation concomitantly." ".After catheter removal, the cox maze iii procedure using cryoablation was performed without complications.The patient recovered with no postoperative complications and was discharged.".

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11185481
• MDR Text Key: 227542245
• Report Number: 2182269-2021-00004
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K102721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR