MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2; CATHETER, STEERABLE

Model Number 401575

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

During the procedure, the catheter became entrapped in a posterior branch of the eyelet vein.Due to difficult device removal, the catheter was left in the patient for the remainder of the procedure.At the end of the case, the device was still stuck so the deflection mechanism was cut off to allow a sheath to advance over the catheter shaft.A dose of verapamil was administered and the catheter was removed successfully.Fluoroscopy was used with contrast to observe the vein but the vein was functioning properly and no damage was noted.The physician did not believe the event was due to a performance issue with the catheter.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6, h10.The reported entrapment issue was unable to be confirmed due to the condition of the returned device.The shaft had been cut off distal to the handle and the handle was note returned.Functional testing was not possible due to the aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported entrapment may have been procedure related.

• Brand Name: LIVEWIRE ELECTROPHYSIOLOGY CATHETER DECAPOLAR, MEDIUM SWEEP ELECTRODE SPACING 2
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9810638
• MDR Text Key: 182709266
• Report Number: 2182269-2020-00027
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (y/n): N
• PMA/PMN Number: K022380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 401575
• Device Catalogue Number: 401575
• Device Lot Number: 7158298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other