MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402807
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial tachycardia procedure, an expired device was used.There was no performance issues noted and there was no patient consequences.
Additional Manufacturer Narrative
An event of ¿an expired device was used¿ was confirmed.A review of distribution records confirmed that this product was distributed after its expiration date.Abbott is continuing to monitor this issue.Records were submitted for evaluation to product performance engineering; no device components were returned.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15118647
• Report Number: 2182269-2022-00034
• Device Sequence Number: 5614716
• Product Code: LPB
• UDI-Device Identifier: 05414734205986
• UDI-Public: 05414734205986
• Combination Product (Y/N): N
• PMA/510(K) Number: P960016-S014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 402807
• Device Catalogue Number: 402807
• Device Lot Number: 6974837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown