MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA 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	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of the event observed during analysis, fracture of the device inside the patient.
Additional Manufacturer Narrative
One pressurewire certus was returned for analysis.The packaging coil and device label were also returned.There were multiple bends and kinks throughout the guidewire.The hydrophilic coated distal tube had been torn and bent at the adhesive joint; the microcables were subsequently fractured; the corewire remained intact.There was corrosion noted at the sensor chip area.Microscopic inspection revealed that a dried blood-like substance was stuck inside the covering of the sensor element (jacket).No other visual anomalies were noted.Electrical testing of the guidewire revealed open circuits between the active/common circuits, passive/common circuits and the active/passive circuits (resistance reading: o.L (over limit)), which is consistent with the fractured microcables (active, passive and common wires).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal loss is consistent with the open circuits resulting from the fractured microcables.The cause of the fractured microcables is consistent with the distal tube damage.The cause of the distal tube damage remains unknown.

• Brand Name: PRESSURE WIRE CERTUS G8
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; 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: 15118594
• Report Number: 3008452825-2022-00523
• Device Sequence Number: 5736000
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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
• Device Expiration Date: 05/31/2022
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 7536284
• 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: 07/01/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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