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

Model Number	401575
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 9810638
• Report Number: 2182269-2020-00027
• Device Sequence Number: 653630
• Product Code: DRA
• UDI-Device Identifier: 05414734202183
• UDI-Public: 05414734202183
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K022380
• 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): 04/17/2020

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: 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
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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