FDA Adverse Event
Malfunction
Summary report: N
FFR LINK
MDR report key: 22183059
·
Received June 11, 2025
Report
- Report Number
- 2124215-2025-37703
- Event Type
- Malfunction
- Date Received
- June 11, 2025
- Date of Event
- May 19, 2025
- Report Date
- June 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQK
- UDI-DI
- 08714729890010
- PMA / PMN Number
- K151613
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
E1: INITIAL REPORTER ADDRESS 1: (B)(6).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE FFR LINK WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE. HOWEVER, DURING PREPARATION, THE DEVICE WOULD NOT START, AND THE POWER LED WAS RED AND BLINKING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89266 | FFR LINK | PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER | DQK | BOSTON SCIENTIFIC CORPORATION | H7495551000 | SPM01338 | 08714729890010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |