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

Model Number	H749555100R0
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that inaccurate values occurred.A ffr link was selected for use.During procedure, it was noted that the wave lengths are showing to different waveforms.The procedure was completed with this device.There were no patient complications.

• 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: 25115675
• Report Number: 2124215-2026-24854
• Device Sequence Number: 13348930
• Product Code: DQK
• UDI-Device Identifier: 08714729939603
• UDI-Public: (01)08714729939603(11)210315(10)SPM05263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: H749555100R0
• Device Catalogue Number: H749555100R0
• Device Lot Number: SPM05263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/07/2026
• Date Device Manufactured: 03/15/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown