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

Model Number	C12008
Medical Device Problem Codes	Fracture (1260); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This event is being reported due to a fractured guidewire noted during analysis.
Additional Manufacturer Narrative
Additional information: d9, g3 one pressurewire certus was returned for analysis.The coated proximal tube (shaft) had been bent and fractured 1245mm from the distal tip, with subsequent fracture of the microcables and corewire.Corrosion was noted at the sensor chip area and the transition area between the hydrophilic coated distal tube and the coated proximal tube (shaft).There were multiple kinks and bends throughout the guidewire.Microscopic inspection revealed damage to the sensor chip area consistent with the corrosion.Functional and electrical testing could not be performed due to the guidewire fracture at the shaft.The proximal section of the guidewire was not returned.How and when the guidewire fracture occurred remains unknown.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 guidewire fracture and reported signal loss 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: 11529248
• Report Number: 3008452825-2021-00165
• Device Sequence Number: 11896319
• 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): 03/29/2021

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: 06/30/2020
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 6564049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1