MAUDE Adverse Event Report: ST. JUDE MEDICAL LIVEWIRE¿ TC ABLATION CATHETER, 4 MM TIP UNIVERSAL TEMPERATURE MONITORING, 115 C; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 402277

Device Problems Signal Artifact/Noise (1036); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Event Description

During the supraventricular tachycardia procedure, an expired catheter was used.It was noted there was a deflection issue of the catheter as well.When the catheter was inserted into the femoral vein, the issue was recognized on signal.Noise was detected on the electrode.The cable was replaced, with no resolution.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.

Event Description

During the paroxysmal supraventricular tachycardia procedure, a deflection issue was noted with the catheter.When the catheter was inserted into the femoral vein, the issue was recognized and noise was detected on the electrode.The cable was replaced, with no resolution.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.Additional information revealed this device was expired at the time of use.

Manufacturer Narrative

One 7f, quadripolar, medium curl, xls livewire tc catheter was received for evaluation.Functional testing revealed the catheter shaft was able to deflect when actuating the steering mechanism; however, the catheter no longer met specifications for curve shape in one direction.The catheter handle was opened, and the device was deflected.Once deflected, it was noted that the slide block was restricting deflection from meeting specifications.Electrodes 1-4 met specifications of acceptable resistance values with no open or short circuits detected.It should be noted that livewire tc ablation catheter batch number 7272743 expired on 31dec2022 which was prior to the reported event date of 17apr2023.A review of distribution records confirmed that this product was distributed prior to its expiration date.The cause of the reported noise remains unknown.Abbott is continuing to monitor the pull wire issue.

• Brand Name: LIVEWIRE¿ TC ABLATION CATHETER, 4 MM TIP UNIVERSAL TEMPERATURE MONITORING, 115 C
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17726564
• MDR Text Key: 323162899
• Report Number: 2182269-2023-00041
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P960016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 402277
• Device Lot Number: 7272743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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