MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FFR LINK; PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER

Model Number	8890
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was not completed.An ffr link was selected for use.During the procedure, the device was able to be zeroed successfully but was unable to record.An "unexpected beat" error was recurring.Rebooting the system and replacing the comet pressure wire did not resolve the issue and the case was abandoned.There were no patient complications reported.
Event or Problem Description
It was reported that the procedure was not completed.An ffr link was selected for use.During the procedure, the device was able to be zeroed successfully but was unable to record.An "unexpected beat" error was recurring.Rebooting the system and replacing the comet pressure wire did not resolve the issue and the case was abandoned.There were no patient complications reported.It was further reported that the patient was sedated with a local anesthesia.
Additional Manufacturer Narrative
The device was returned for analysis.The console was tested and failed to turn on when the main power was turned on.
Event or Problem Description
It was reported that the procedure was not completed.An ffr link was selected for use.During the procedure, the device was able to be zeroed successfully but was unable to record.An "unexpected beat" error was recurring.Rebooting the system and replacing the comet pressure wire did not resolve the issue and the case was abandoned.There were no patient complications reported.It was further reported that the patient was sedated with a local anesthesia.

• Brand Name: FFR LINK
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 19249965
• Report Number: 2124215-2024-27467
• Device Sequence Number: 7337210
• Product Code: DQK
• UDI-Device Identifier: 08714729890010
• UDI-Public: 08714729890010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2025

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: 8890
• Device Catalogue Number: 8890
• Device Lot Number: SPM01464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 02/26/2025
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/28/2024; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown