FATHOM? -16
Report
- Report Number
- 2124215-2025-40219
- Event Type
- Malfunction
- Date Received
- June 23, 2025
- Date of Event
- May 26, 2025
- Report Date
- August 12, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQX
- UDI-DI
- 08714729762553
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4: PREMARKET/510(K) #: K111485, K170636.
G4: PREMARKET/510(K) #: K111485, K170636. DEVICE EVALUATED BY MFR: THE FATHOM GUIDEWIRE WAS RETURNED WITH THE TORQUER DEVICE. VISUAL AND MICROSCOPIC INSPECTION REVEALED THAT THE DISTAL TIP WAS DETACHED, WHICH CONFIRMED THE REPORTED OBSERVATION.
IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 180X25CM FATHOM 16 .016 PERPH GW WAS USED FOR PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE SEPARATED. THE DETACHED TIP WAS REMOVED BY WITHDRAWING THE BASE OF THE CATHETER, AND IT REMAINED INTACT WITHIN THE CATHETER BASE. THE TIP WAS ULTIMATELY RETRIEVED FROM THE PATIENT IN TWO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. A 180X25CM FATHOM 16 .016 PERPH GW WAS USED FOR PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE SEPARATED. THE DETACHED TIP WAS REMOVED BY WITHDRAWING THE BASE OF THE CATHETER, AND IT REMAINED INTACT WITHIN THE CATHETER BASE. THE TIP WAS ULTIMATELY RETRIEVED FROM THE PATIENT IN TWO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1219185 | FATHOM? -16 | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC CORPORATION | M001509100 | 0036078471 | 08714729762553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |