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

Model Number	C12008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pressurewire certus was returned for analysis.The results of the investigation revealed the shaft had been kinked and fractured, with subsequent fracture of the microcables; the corewire remained intact and had been exposed.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 remains unknown.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a fracture.

• 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: 11826361
• Report Number: 3008452825-2021-00281
• Device Sequence Number: 19097934
• 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
• Report Date (Section B): 05/14/2021

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: 7335855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1