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

Model Number	C12008
Medical Device Problem Code	Connection Problem (2900)
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 conduit was unable to be connected during use of the pressure wire and the procedure was aborted.
Additional 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 incident could not be conclusively determined.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h2 one pressurewire certus was returned for analysis.Visual inspection revealed bends throughout the guidewire.The ptfe coating had been scraped off the coated proximal tube (shaft) at multiple locations.Microscopic inspection revealed a dried salt-like substance was stuck inside the covering of the sensor element (jacket).The results of the investigation concluded that after inserting the guidewire into the proximal cable then tightening the cap, the guidewire remained stationary during functional testing.Functional testing also 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 connection issue and subsequent cancellation remains unknown.

• 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: 11263043
• Report Number: 3008452825-2021-00066
• Device Sequence Number: 11608935
• 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): 05/04/2021

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: 03/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/16/2021; 05/04/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/16/2021; 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR