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

Model Number	C12008
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
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 had been kinked and the shaft had been kinked 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 reported signal loss is consistent with the guidewire damage.The cause of the guidewire damage is consistent with damage during use.Abbott is continuing to monitor the signal loss issue.
Event or Problem Description
During the procedure, the device fractured inside the patient's anatomy and the signal was lost.Another device was used to complete the procedure with no adverse patient consequences.

• 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, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10426879
• Report Number: 3008452825-2020-00424
• Device Sequence Number: 14188727
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 05/31/2021
• Device Model Number: C12008
• Device Catalogue Number: C12008
• Device Lot Number: 7057663
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1