MAUDE Adverse Event Report: ST. JUDE MEDICAL QUANTIEN; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	C12787
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the system was showing a pd interface error and there was no connection with the pressurewire.It tech support provided a list of instructions to check the quantien¿s system.Upon assessment, it was noted that a cable that had been pulled from the rear of the quantien and inserted into the wrong port.Once the cable was removed and inserted into correct port, the interface error was resolved.The procedure was cancelled due to the inability to obtain a reading during the procedure.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: QUANTIEN
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11285178
• Report Number: 2184149-2021-00012
• Device Sequence Number: 14338427
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: 05415067000996
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K123984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C12787
• Device Catalogue Number: C12787
• Device Lot Number: 6006457
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other