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

Model Number	C12009
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
After insertion into the patient, the tip of the device broke.The device was replaced to complete the procedure with no adverse patient consequences.
Event or Problem Description
Additional information received indicated that the tip of the device did not break.During the procedure, after the device was inserted into the patient, the signal was lost.The device was replaced to complete the procedure with no adverse patient consequences.
Additional Manufacturer Narrative
One pressurewire x, cabled was returned for analysis.The results of the investigation confirmed the pressurewire met functional specifications when analyzed for signal loss.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported signal loss was unable to be conclusively determined.

• 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 1897- 4050; CS 1897-4050
• MDR Report Key: 8752684
• Report Number: 3008452825-2019-00306
• Device Sequence Number: 14052973
• Product Code: DQX
• UDI-Device Identifier: 05415067025739
• UDI-Public: 05415067025739
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K180558
• 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,Followup,Followup
• Report Date (Section B): 09/05/2019

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: 12/31/2019
• Device Model Number: C12009
• Device Lot Number: 6297837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/07/2019; 08/30/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/26/2019; 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1