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

Model Number	H7495551000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1-initial reporter facility name: (b)(6).E1-initial reporter address: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.A ffr link was selected for use.It was reported that the pole was damaged.No further information is available.

• 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: 24512512
• Report Number: 2124215-2026-11973
• Device Sequence Number: 10415404
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: Other
• Device Model Number: H7495551000
• Device Catalogue Number: H7495551000
• Device Lot Number: SPM03564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• 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