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

Model Number	C12008
Medical Device Problem Codes	Difficult to Insert (1316); Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3008452825-2022-00598
• Device Sequence Number: 6020831
• Product Code: DQX
• UDI-Device Identifier: 05414734055758
• UDI-Public: 05414734055758
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 02/21/2023
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/04/2022; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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