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-F15

Device Problems Signal Artifact/Noise (1036); Expiration Date Error (2528)

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

Event Date 10/21/2023

Event Type  malfunction  

Event Description

Information received confirmed the device was expired when used.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported noise remains unknown.Additional information received on 3/28/24 confirmed the correct lot number is 8622315 and the correct event date was october 21, 2023.The expiration date of this lot was january 31, 2024 and was therefore not expired at the time of use and is no longer a reportable event.

Event Description

Additional information received on 3/28/24 confirmed the correct lot number is 8622315 and the correct event date was october 21, 2023.The expiration date of this lot was january 31, 2024 and was therefore not expired at the time of use.

Manufacturer Narrative

One 15mm loop, uni-directional, curve d, sensor enabled, advisor fl circular mapping catheter was received for evaluation.Electrodes 1-2 met specifications for acceptable resistance values with no open or short circuits detected.This advisor fl circular mapping catheter batch number 8368219 expired on 31aug2023 which was prior to the reported event date of 23nov2023.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.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, COSTA RICA LTDA (AFD); 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: 18778608
• MDR Text Key: 336229520
• Report Number: 3008452825-2024-00105
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067024800
• UDI-Public: (01)05415067024800(10)8622315(17)240131
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160335, K20
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: D-AVSE-D10-F15
• Device Lot Number: 8622315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1