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

Model Number 401904

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Tissue Damage (2104)

Event Date 10/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During an electrophysiology procedure, the livewire duo decapolar catheter became lodged in the right atrium.The livewire duo decapolar catheter was inserted via a fast cath introducer into the right atrium.During placement of the catheter, it became lodged in the right atrium and could neither be advanced or withdrawn.After 15 to 20 minutes attempting to remove the catheter a cardiologist was consulted and the catheter was removed using a superior approach via the internal jugular vein utilizing a snare technique.It is believed the catheter became lodged in the right atrium during manipulation while attempting placement but it is unknown what structure the catheter was caught on.After the catheter was removed the procedure was abandoned and the patient was in stable condition.

Manufacturer Narrative

(b)(4).One 7f, duo-decapolar, super large curl, livewire ep catheter was received for evaluation.The results of the investigation concluded that the catheter shaft deflected when actuating the steering mechanism, but no longer deflected in the correct shape according to specifications, due to a kink and bends in the shaft.The catheter met specifications prior to release from sjm manufacturing facilities as supported by a review of the device history record.The cause of the shaft damage is consistent with damage to the device during use.The cause of the reported event remains unknown.

Event Description

Additional information received indicates this was an ablation procedure; however, the procedure was canceled after the device became lodged in the heart.

• Brand Name: LIVEWIRE¿ ELECTROPHYSIOLOGY CATHETER DUO-DECAPOLAR (20 ELECTRODES), SUPER LARGE
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5213255
• MDR Text Key: 30845297
• Report Number: 3005188751-2015-00117
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 401904
• Device Lot Number: 5136254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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