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

Model Number	H7495551000
Medical Device Problem Codes	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The ffr link was selected for treatment.However, the power code was found broken and the device could not be turned on.The procedure was not completed due to this event.There were no patient complications and the patient was in good condition.
Event or Problem Description
It was reported that the procedure was cancelled.The ffr link was selected for treatment.However, the power code was found broken and the device could not be turned on.The procedure was not completed due to this event.There were no patient complications and the patient was in good condition.It was further reported that the procedure was not cancelled.It was completed with other equipment and the patient was under local anesthesia.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review if completed: a risk review was completed and confirmed that the event of power cord damage/defective (power supply failure) 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: this investigation is assigned an investigation conclusion code of cause traced to component failure.This conclusion was selected because the reason for the power cord was broken was most likely determined to be the power cord the field service engineer (fse) analysis onsite.Furthermore, field service engineer (fse) replaced of the power cord has resolved the complaint.
Event or Problem Description
It was reported that the procedure was cancelled.The ffr link was selected for treatment.However, the power code was found broken and the device could not be turned on.The procedure was not completed due to this event.There were no patient complications and the patient was in good condition.It was further reported that the procedure was not cancelled.It was completed with other equipment and the patient was under 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: 20780329
• Report Number: 2124215-2024-74340
• Device Sequence Number: 5003901
• Product Code: DQK
• UDI-Device Identifier: 08714729890010
• UDI-Public: 08714729890010
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: SPM05937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 02/16/2026
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/09/2024; 03/09/2026
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown