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

Model Number	C12008
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, it was noted that the a portion of the guidewire detached from the device.The device was exchanged and the procedure was completed with no adverse consequences to the patient.
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 remains unknown.
Additional Manufacturer Narrative
One pressurewire certus was returned for analysis.The results of the investigation concluded that the shaft had been fractured and separated, with subsequent fracture of the microcables; the corewire remained intact and had been exposed.It was noted that the corewire and shaft had been bent and flattened at the location of the fracture.The combined length of the two shaft sections is consistent with no missing material from the guidewire assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire damage 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
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13087786
• Report Number: 3008452825-2021-00599
• Device Sequence Number: 5734643
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2022

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: 05/31/2022
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 7549533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/18/2022; 03/11/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 01/18/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown