MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FFR Link; Programmable Diagnostic Computer, Blood Pressure Computer

Model Number	H7495551000
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A ffr link and ge pd out cable were selected for use.During capital equipment maintenance, no signal displayed.The pd out connection port seems to be damaged on the ffr link.The procedure was cancelled.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 ; +1(612)875-7234
• MDR Report Key: 25631412
• Report Number: 2124215-2026-34111
• Device Sequence Number: 9552627
• Product Code: DQK
• UDI-Device Identifier: 08714729890010
• UDI-Public: (01)08714729890010(11)200706(10)SPM04380
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: H7495551000
• Device Catalogue Number: H7495551000
• Device Lot Number: SPM04380
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 07/06/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown