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

Model Number C12008

Device Problems Fracture (1260); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2020

Event Type  malfunction  

Event Description

This event is being reported due to a fractured guidewire noted during analysis.

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
• Type of Device: 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
• MDR Text Key: 242389968
• Report Number: 3008452825-2021-00165
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 05414734055758
• UDI-Public: 05414734055758
• Combination Product (y/n): N
• PMA/PMN Number: K140466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1