MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-AVSE-D10-F20

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

This event is being reported as the device used during the procedure had expired.There were no consequences to the patient.

Manufacturer Narrative

One 20mm loop, uni-directional, curve d, sensor enabled, advisor fl circular mapping catheter, was received for evaluation.The results of the investigation confirmed that advisor fl, circular mapping catheter, se batch number 7572721 expired on 31dec2021 which was prior to the reported event date of (b)(6) 2022.A review of distribution records confirmed that this product was distributed prior to its expiration date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.Based on the information received, the cause of the use of expired product is consistent with user error.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13236897
• MDR Text Key: 283679231
• Report Number: 3008452825-2022-00013
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067024817
• UDI-Public: 05415067024817
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K160335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: D-AVSE-D10-F20
• Device Catalogue Number: D-AVSE-D10-F20
• Device Lot Number: 7572721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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