FATHOM? -16
Report
- Report Number
- 2124215-2025-25130
- Event Type
- Malfunction
- Date Received
- April 22, 2025
- Date of Event
- March 19, 2025
- Report Date
- August 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQX
- UDI-DI
- 08714729762553
- PMA / PMN Number
- K111485
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4 - PREMARKET / 510(K) #: K111485, K170636. THIS IS DETERMINED TO BE A DUPLICATE. BASED ON FEEDBACK, THE ORIGINAL COMPLAINT HAD ALREADY BEEN REPORTED VIA MEDWATCH (B)(4).
G4 - PREMARKET / 510(K) #: K111485, K170636.
BASED ON THE ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED THAT THE COMPLAINT HAD BEEN REPORTED VIA MEDWATCH 0300640000-2025-8009, AND NOT VIA MEDWATCH 0300640000-2025-8011 AS PREVIOUSLY REPORTED. ALSO, B5 HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION ABOUT ARTERIAL ACCESS BASED ON THE MEDWATCH FORM. G4 - PREMARKET / 510(K) #: K111485, K170636.
G4 - PREMARKET / 510(K) #: K111485, K170636. DEVICE EVALUATED BY MFR: THE FATHOM DEVICE WAS RETURNED FOR ANALYSIS. UPON EXAMINATION, THE GUIDEWIRE, RETURNED ATTACHED TO THE TORQUER DEVICE, SHOWED DETACHMENT AND KINKING AT THE DISTAL TIP. MICROSCOPE INSPECTION CONFIRMED THE DISTAL TIP WAS DETACHED.
IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTY OCCURRED. A 180X25CM FATHOM -16 WAS SELECTED FOR USE VIA RIGHT FEMORAL ACCESS WITH A BASE 5F CATHETER POSITIONED AT THE CELIAC ARTERY ORIGIN. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO CANNULATE THE HEPATIC ARTERY. IN ATTEMPT TO REACH DISTAL HEPATIC BRANCH, FATHOM WIRE BECAME DIFFICULT TO ADVANCE. ATTEMPTED REPOSITION OF MICROCATHETER AND ADVANCING THE WIRE AGAIN WAS UNSUCCESSFUL. THE PHYSICIAN TRIED TO RETRIEVE THE WIRE TO REFORM THE TIP SHAPE BUT WAS UNABLE TO PULL IT BACK. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE WIRE, THE MICROCATHETER AND WIRE WERE PULLED OUT TOGETHER AS ONE PIECE. IT WAS THEN NOTED THAT THE WIRE HAD STARTED TO UNRAVEL INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTY OCCURRED. A 180X25CM FATHOM? -16 WAS SELECTED FOR USE VIA RIGHT FEMORAL ACCESS WITH A BASE 5F CATHETER POSITIONED AT THE CELIAC ARTERY ORIGIN. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO CANNULATE THE HEPATIC ARTERY. IN ATTEMPT TO REACH DISTAL HEPATIC BRANCH, FATHOM WIRE BECAME DIFFICULT TO ADVANCE. ATTEMPTED REPOSITION OF MICROCATHETER AND ADVANCING THE WIRE AGAIN WAS UNSUCCESSFUL. THE PHYSICIAN TRIED TO RETRIEVE THE WIRE TO REFORM THE TIP SHAPE BUT WAS UNABLE TO PULL IT BACK. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE WIRE, THE MICROCATHETER AND WIRE WERE PULLED OUT TOGETHER AS ONE PIECE. IT WAS THEN NOTED THAT THE WIRE HAD STARTED TO UNRAVEL INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTY OCCURRED. A 180X25CM FATHOM -16 WAS SELECTED FOR USE VIA RIGHT FEMORAL ACCESS WITH A BASE 5F CATHETER POSITIONED AT THE CELIAC ARTERY ORIGIN. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO CANNULATE THE HEPATIC ARTERY. IN ATTEMPT TO REACH DISTAL HEPATIC BRANCH, FATHOM WIRE BECAME DIFFICULT TO ADVANCE. ATTEMPTED REPOSITION OF MICROCATHETER AND ADVANCING THE WIRE AGAIN WAS UNSUCCESSFUL. THE PHYSICIAN TRIED TO RETRIEVE THE WIRE TO REFORM THE TIP SHAPE BUT WAS UNABLE TO PULL IT BACK. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE WIRE, THE MICROCATHETER AND WIRE WERE PULLED OUT TOGETHER AS ONE PIECE. IT WAS THEN NOTED THAT THE WIRE HAD STARTED TO UNRAVEL INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ULTRASOUND-GUIDED ARTERIAL ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY.
IT WAS REPORTED THAT GUIDEWIRE REMOVAL DIFFICULTY OCCURRED. A 180X25CM FATHOM? -16 WAS SELECTED FOR USE VIA RIGHT FEMORAL ACCESS WITH A BASE 5F CATHETER POSITIONED AT THE CELIAC ARTERY ORIGIN. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO CANNULATE THE HEPATIC ARTERY. IN ATTEMPT TO REACH DISTAL HEPATIC BRANCH, FATHOM WIRE BECAME DIFFICULT TO ADVANCE. ATTEMPTED REPOSITION OF MICROCATHETER AND ADVANCING THE WIRE AGAIN WAS UNSUCCESSFUL. THE PHYSICIAN TRIED TO RETRIEVE THE WIRE TO REFORM THE TIP SHAPE BUT WAS UNABLE TO PULL IT BACK. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE WIRE, THE MICROCATHETER AND WIRE WERE PULLED OUT TOGETHER AS ONE PIECE. IT WAS THEN NOTED THAT THE WIRE HAD STARTED TO UNRAVEL INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ULTRASOUND-GUIDED ARTERIAL ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629168 | FATHOM? -16 | WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC CORPORATION | M001509100 | 0035627349 | 08714729762553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | MICROCATHETER - 2.8FR PROGREAT 130CM| MICROCATHETER - 2.8FR PROGREAT 130CM| MICROCATHETER - 2.8FR PROGREAT 130CM| MICROCATHETER - 2.8FR PROGREAT 130CM |