Headway Advanced MC17215045XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810170015496), received between Dec 19, 2023 and Dec 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT RUPTURE OF THE PROXIMAL THIRD OF THE MICROCATHETER AFTER COMPLETING COILING AND PULL IT BACK OUTSIDE THE ANEURYSM SAC. ADDITIONAL INFORMATION RECEIVED INDICATED, THIS IS IN RELATION TO THE ABOVE REPORTED EVENT, I WOULD LIKE TO IDENTIFY THAT THE SENT MICROCATHETER HAS BEEN USED TO TREAT SUCCESSFULLY A RIGHT PARAOPTHALMIC SACCULAR ANEURYSM THROUGH A LONG 6F SHEATH AND A 5F SOPHIA INTERMEDIATE CATHETER AND AFTER FINISHING THE COILING PROCESS AND REMOVE THE SENT HEADWAY 17 MICROCATHETER OVER THE TRAXCESS 14 WIRE OUT OF THE ANEURYSM SAC INTO THE CAROTID SIPHON, WE HAVE LOST CONTROL OF THE MICROCATHETER AS WE PULLED OUT ITS PROXIMAL PART BUT NOT MOVING THE UPPER PART UP TO THE SIPHON. AS A RESULT, THE PROXIMAL PART OF THE CATHETER WHICH WE HAVE SENT EVENTUALLY HAD BEEN PULLED OUT BUT THE UPPER PART OF IT REMAINED INTO THE ARTERIAL NETWORK. HOPEFULLY, THE PATIENT WAS AND REMAINS VERY WELL AND THE CAROTID IS FULKLY PATENT UNDER DUAL ANTIPLATELET TREATMENT AND THE 3 MONTHS ANGIOGRAM IS FINE (SEE THE ATTACHED PICTURES - RT ICA COILED RT A2 ANEURYSM TREATED AS WELL DURING THIS PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18361487 ↗