MAUDE Adverse Event Report: Abbott 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	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a fractional flow reserve procedure with quantien, it was noted that the pa signals were not appearing on the monitor leading to the procedure being cancelled.There were no adverse patient consequences.

• Brand Name: QUANTIEN
• Common Device Name: Computer, Diagnostic, Programmable
• Manufacturer (Section D): Abbott Medical; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): Abbott Medical; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50952342
• Report Number: 2184149-2026-00257
• Device Sequence Number: 9552251
• Product Code: DQK
• UDI-Device Identifier: 05415067000996
• UDI-Public: (01)05415067000996(10)7297795
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 7297795
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2019
• 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