FDA Adverse Event
Malfunction
Summary report: N
FFR LINK
MDR report key: 25115675
·
Received May 7, 2026
Report
- Report Number
- 2124215-2026-24854
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- April 17, 2026
- Report Date
- May 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQK
- UDI-DI
- 08714729939603
- PMA / PMN Number
- K151613
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98526 | FFR LINK | PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER | DQK | BOSTON SCIENTIFIC CORPORATION | H749555100R0 | SPM05263 | 08714729939603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |