MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSUREWIRE X, CABLED, RX 175CM; WIRE, GUIDE, CATHETER

Model Number	C12009
Medical Device Problem Codes	Material Separation (1562); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One pressurewire x, cabled was returned for analysis.The packaging coil and device label were also returned.The results of the investigation were inconclusive.Functional testing and electrical testing could not be performed due to the guidewire fracture at the transitional area between the hydrophilic coated distal tube and the coated proximal tube (shaft).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 reported signal loss was unable to be conclusively determined; however, abbott is continuing to monitor this issue.
Event or Problem Description
During the procedure, the device fractured inside the patient's anatomy and lost signal before equalization could be performed.The device was replaced and the procedure was completed with no adverse patient consequences.

• Brand Name: PRESSUREWIRE X, CABLED, RX 175CM
• 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: 10425738
• Report Number: 3008452825-2020-00423
• Device Sequence Number: 2943028
• Product Code: DQX
• UDI-Device Identifier: 05415067025739
• UDI-Public: 05415067025739
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161171
• 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: 04/30/2020
• Device Model Number: C12009
• Device Catalogue Number: C12009
• Device Lot Number: 6481946
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1