FDA Adverse Event
Malfunction
Summary report: N
FFR LINK
MDR report key: 24512512
·
Received March 4, 2026
Report
- Report Number
- 2124215-2026-11973
- Event Type
- Malfunction
- Date Received
- March 4, 2026
- Date of Event
- February 4, 2026
- Report Date
- March 4, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQK
- UDI-DI
- 08714729890010
- PMA / PMN Number
- K151613
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
E1-INITIAL REPORTER FACILITY NAME: (B)(6). E1-INITIAL REPORTER ADDRESS: (B)(6).
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205762 | FFR LINK | PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER | DQK | BOSTON SCIENTIFIC CORPORATION | H7495551000 | SPM03564 | 08714729890010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |