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

Model Number	C12787
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, there was drifting causing a delay.The steps of the procedure were performed again which did not resolve the issue.Abbott personal evaluated the technique used at the site (time, flush, positioning, equalized, zero), everything was fine and all the measurement of rfr were accurate with no drift noted.
Additional Manufacturer Narrative
Additional information confirmed the complaint device involved was the pressurewirex which are handled by the abbott vascular team.The regulatory reports will be submitted by that team.
Event or Problem Description
During a procedure, there was drifting causing a delay.The steps of the procedure were performed again which did not resolve the issue.Abbott personal evaluated the technique used at the site (time, flush, positioning, equalized, zero), everything was fine and all the measurement of rfr were accurate with no drift noted.But from the beginning; they did a complaint for the ¿drift¿ suspecting the quantien or the pwx.Per a conversation with abbott vascular r&d, it was confirmed that it¿s not possible for the quantien to cause or contribute to the drift; it would come from the pressure wirex.

• Brand Name: QUANTIEN
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15321598
• Report Number: 2184149-2022-00186
• Device Sequence Number: 20140530
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: 05415067000996
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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 Model Number: C12787
• Device Catalogue Number: C12787
• Device Lot Number: 7200826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown