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

Model Number 402807

Device Problem Use of Device Problem (1670)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

During the atrial tachycardia procedure, an expired device was used.There was no performance issues noted and there was no patient consequences.

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
• Type of Device: 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
• MDR Text Key: 303818633
• Report Number: 2182269-2022-00034
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05414734205986
• UDI-Public: 05414734205986
• Combination Product (y/n): N
• PMA/PMN Number: P960016-S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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