DIREXION? FATHOM?-16 SYSTEM
Report
- Report Number
- 2124215-2026-07135
- Event Type
- Malfunction
- Date Received
- February 9, 2026
- Date of Event
- January 13, 2026
- Report Date
- April 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KRA
- UDI-DI
- 08714729839644
- PMA / PMN Number
- K142259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4 - PREMARKET / 510(K) #: K142259, K163701 INVESTIGATION RESULTS: DEVICE EVALUATED BY MFR: THE DIREXION DEVICE WAS RETURNED TO OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE RETURNED DEVICE CONSISTS OF DIREXION MICROCATHETER IN 3 SEPARATE PIECES AS THE SHAFT IS DETACHED FROM THE LUER AND PIECE OF THE HYPO TUBE IS REMOVED FROM THE SHAFT. VISUAL EXAMINATION REVEALS A NICKEL SHAFT FRACTURED IS LOCATED AT THE HUB. ANOTHER NICKEL SHAFT FRACTURE IS LOCATED APPROXIMATELY 19CM FROM THE HUB. THE INNER LUMEN IS STRETCHED APPROXIMATELY 1CM. THIS CONCLUDES THE PRODUCT ANALYSIS. DEVICE HISTORY RECORD: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW PERFORMED FOR THE DIREXION DEVICE CONFIRMED THAT THE REPORTED EVENT IS A KNOWN EVENT DEFINED IN THE PRODUCT'S RISK MANAGEMENT DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFITS FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE LINKED TO DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY.
G4 - PREMARKET / 510(K) #: K142259, K163701. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, INITIAL REPORTER, AND PRODUCT RETURN STATUS, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
E. INITIAL REPORTER - UPDATED TO PHYSICIAN DETAILS. G4 - PREMARKET / 510(K) #: K142259, K163701.
IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A DIREXION FATHOM -16 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE MICROCATHETER FRACTURED INTO SEVERAL SEGMENTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A DIREXION? FATHOM?-16 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE MICROCATHETER FRACTURED INTO SEVERAL SEGMENTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT MICROCATHETER FRACTURE OCCURRED. A DIREXION? FATHOM?-16 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER WAS INTRODUCED INTO THE PATIENT. HOWEVER, THE MICROCATHETER FRACTURED INTO SEVERAL SEGMENTS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171290 | DIREXION? FATHOM?-16 SYSTEM | CATHETER, CONTINUOUS FLUSH | KRA | BOSTON SCIENTIFIC CORPORATION | M001195650 | 0036578861 | 08714729839644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |