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

Model Number	H749555100R0
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An ffr link was selected for examination of the target lesion.During use, the device experienced an error and was unable to send waveforms.Because of this, the procedure was not able to be completed.There were no patient complications.
Additional Manufacturer Narrative
The returned product consisted of the ffr link.A visual inspection of the device revealed it was in good condition.When the device was put through functional testing, it did not fail any of the steps.The lab was not able to confirm the reported events, as the investigation revealed no damages or deficiencies.
Event or Problem Description
It was reported that the procedure was cancelled.An ffr link was selected for examination of the target lesion.During use, the device experienced an error and was unable to send waveforms.Because of this, the procedure was not able to be completed.There were no patient complications.
Additional Manufacturer Narrative
E1 initial reporter address: (b)(6).The returned product consisted of the ffr link.A visual inspection of the device revealed it was in good condition.When the device was put through functional testing, it did not fail any of the steps.The lab was not able to confirm the reported events, as the investigation revealed no damages or deficiencies.
Event or Problem Description
It was reported that the procedure was cancelled.An ffr link was selected for examination of the target lesion.During use, the device experienced an error and was unable to send waveforms.Because of this, the procedure was not able to be completed.There were no patient complications.
Additional Manufacturer Narrative
A correction report is being submitted to include investigation information.E1 initial reporter address: (b)(6).Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the event.Device technical analysis: the returned product consisted of the ffr link console.A visual inspection and functional test revealed no damages or defects with the device.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a risk review was completed and confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown (prolonged procedure - limited) was defined in the risk documentation.These event type have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: a thorough review of the available information in the complaint did not find any fault condition(s) with the product related to the reported complaint allegation.The investigation conclusion code of no problem detected was selected.
Event or Problem Description
It was reported that the procedure was cancelled.An ffr link was selected for examination of the target lesion.During use, the device experienced an error and was unable to send waveforms.Because of this, the procedure was not able to be completed.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: 21808571
• Report Number: 2124215-2025-22102
• Device Sequence Number: 12654468
• Product Code: DQK
• UDI-Device Identifier: 08714729939603
• UDI-Public: (01)08714729939603(11)200430(10)SPM04209
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2026

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: SPM04209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 03/19/2026; 04/21/2026
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/03/2025; 04/14/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2020
• 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