FDA Adverse Event
Malfunction
Summary report: N
FATHOM -16
MDR report key: 20835928
·
Received December 3, 2024
Report
- Report Number
- 2124215-2024-75644
- Event Type
- Malfunction
- Date Received
- December 3, 2024
- Date of Event
- November 12, 2024
- Report Date
- December 3, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQX
- UDI-DI
- 08714729762553
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
G4: PREMARKET/510(K)#: K111485, K170636
Description of Event or Problem · 0
IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. THE TARGET LESION, A STENOSED SEGMENT, WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT PROSTATE VESSEL. A 180X25 CM FATHOM GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE FAILED TO ADVANCE, AND FRACTURE OF THE WIRE WAS IDENTIFIED. TO PREVENT UNINTENDED EMBOLIZATION, THE GUIDEWIRES AND MICROCATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2218733 | FATHOM -16 | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC CORPORATION | M001509100 | 0034876025 | 08714729762553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |