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

Model Number	C12008
Medical Device Problem Codes	Use of Device Problem (1670); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the procedure, an expired device was used inside the patient.The device was exchanged and the procedure was completed successfully with no adverse patient consequences.
Additional Manufacturer Narrative
Additional information: d10, g4, g7, h2, h3, h6.One pressurewire certus was returned for analysis.The results of the investigation confirmed that pressurewire certus, batch number 6749049 expired on (b)(6) 2020, which was prior to the reported event date of (b)(6) 2020.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.The cause of the use of expired product is consistent with user error.
Additional Manufacturer Narrative
One pressurewire certus was returned for analysis. functional testing of the device and electrical testing of the guidewire could not be performed due to corrosion at the sensor chip area consistent with sensor chip damage, which precludes further testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported signal loss was unable to be conclusively determined.
Event or Problem Description
During the procedure, a measurement was unable to be taken due to signal loss.The device was exchanged and the procedure was completed successfully with no adverse patient consequences.

• 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
• MDR Report Key: 10929376
• Report Number: 3008452825-2020-00673
• Device Sequence Number: 18969252
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 6749049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2020
• Supplement Date Received by Manufacturer: 12/30/2020; 12/30/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/04/2021; 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other