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

Model Number	C12008
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the pressurewire was unable to connect to the conduit.The operation was aborted.The patient experienced no adverse consequences.
Additional Manufacturer Narrative
Only the fractional flow reserve portion of the percutaneous coronary intervention was cancelled due to the signal loss.The procedure was completed without fractional flow reserve measurement.One pressurewire certus was returned for analysis.The reported event of a signal calibration issue could not be confirmed.Functional testing confirmed the pressurewire was able to be connected and calibrated and met functional specifications when analyzed.No functional anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal calibration issue remains unknown.
Event or Problem Description
Only the fractional flow reserve portion of the percutaneous coronary intervention was cancelled due to the signal loss.The procedure was completed without fractional flow reserve measurement.

• 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: 11331699
• Report Number: 3008452825-2021-00032
• Device Sequence Number: 3416482
• 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
• Report Date (Section B): 03/08/2021

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: 7365632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR