MAUDE Adverse Event Report: ST. JUDE MEDICAL PRESSURE WIRE CERTUS G8; WIRE, GUIDE, CATHETER

Model Number C12008

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); No Apparent Adverse Event (3189)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

During the procedure, an expired catheter was used.The catheter was used to be implanted in lcx with heavy tortuosity and calcification.It was found that it was unable to cross the lesion before implanting the stent.The failure to cross the lesion was due to the patient anatomy and not due to the interaction of devices.No resistance was felt during the process.No other device issues or procedure issues were noted.The catheter was exchanged with the same size and the procedure was completed with no patient consequences.

Manufacturer Narrative

The hospital returned the unused sterile pressure wire due to expiration, making this event not reportable.The results of the investigation are inconclusive since the device was not returned for analysis.However, certus pressure wire batch number 7354924 expired on 31122021 which was prior to the reported event date of 12082022.  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 reported incident could not be conclusively determined.

Manufacturer Narrative

The hospital returned this product to the distributor due to expiration, not the product used during surgery.Because the distributor did not inform the internal service of this matter, the internal service misreported this information.The pressure wire is not a reportable device.

Event Description

The expired pressure wire was not used during the procedure or on the patient, making this event not reportable.

• Brand Name: PRESSURE WIRE CERTUS G8
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a; edificio #44b, calle 0, avenida 2, coyol; alajuela 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15476032
• MDR Text Key: 302955272
• Report Number: 3008452825-2022-00598
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 05414734055758
• UDI-Public: 05414734055758
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 7354924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 09/27/2022; 02/21/2023
• Supplement Dates FDA Received: 10/04/2022; 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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