ASAHI Gaia Third AHW14R011PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327094788), received between Jul 26, 2017 and Sep 18, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GAIA THIRD GUIDE WIRE BROKE DURING A PCI TO TREAT A HEAVILY CALCIFIED CTO AT THE SAPHENOUS VEIN GRAFT TO THE LAD. THE GUIDE WIRE WAS BEING USED TO CROSS THE LESION WHEN THE TIP BROKE. ALL THE WIRE CAME OUT OF THE VESSEL AS IT WAS FELT LIKE THE SPRING COIL HELD THE TIP OF THE WIRE DURING REMOVAL. THE PROCEDURE WAS CONTINUED WITH SEVERAL OTHER NON-ASAHI PRODUCTS;,HOWEVER, NONE OF THEM WAS ABLE TO CROSS THE BLOCKAGE. THE PATIENT WAS STABLE WITHOUT KNOWN ADVERSE EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10551859 ↗
• MalfunctionSep 6, 2020Break

  PATIENT IS STABLE AND NO KNOWN EFFECTS FROM CASE. MD STATES CASE WAS VERY DIFFICULT AND VESSEL WAS VERY CALCIFIED. GAIA 3 WAS BEING USED TO CROSS LESION WHEN HE FELT LIKE THE TIP BROKE. MD SAID HE IS SURE ALL THE WIRE CAME OUT OF VESSEL AND FEELS LIKE SPRING COIL HELD TIP OF WIRE DURING REMOVAL. MD STATES THE VESSEL WAS SO HARD WITH CALCIUM THAT SEVERAL OTHER PRODUCTS(NON-ASAHI), MICRO CATHETERS AND WIRES ALSO CAME OUT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10498208 ↗
• InjuryJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE ASAHI GUIDE WIRE WENT THROUGH THE CONCOMITANT MICROCATHETER AND BECAME STUCK IN THE LESION FROM THE SECOND IT TRIED CROSSING THE LESION. INTERVENTION WAS ATTEMPTED FOR 5.5 HOURS TO REMOVE THE DEVICE. A SMALL FILAMENT OF THE GUIDE WIRE REMAINED IN THE RCA AND THE PATIENT WOULD HAVE CARDIAC SURGERY IN THE NEXT FEW DAYS. THE PATIENT WAS STABLE AFTER THE PCI. ON (B)(6) 2019, THE PATIENT RECEIVED CORONARY ARTERY BYPASS GRAFT (CABG) OF THE RCA (THE SURGERY WAS NOT SCHEDULE TO REMOVE THE WIRE FRAGMENT, BUT FOR THE CORONARY BYPASS ON THE RCA.). THE REMAINING PIECE OF THE GUIDE WIRE WAS COMPLETELY REMOVED DURING THE BYPASS. THE PATIENT IS STABLE AND RECOVERING WELL.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8738185 ↗
• InjuryNov 22, 2017Detachment Of Device Component; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVY CALCIFICATION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE ASAHI GAIA GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND BECAME STUCK IN THE CALCIFIED VESSEL. DURING THE ATTEMPT TO WITHDRAW THE GUIDE WIRE, THE TIP OF THE GUIDE WIRE SNAPPED. DUE TO THE VESSEL CALCIFICATION, THERE WAS NO ATTEMPT TO RETRIEVE THE SEPARATED TIP OF THE GUIDE WIRE AND THE PROCEDURE WAS STOPPED. THE SEPARATED GUIDE WIRE TIP REMAINS STUCK IN THE CALCIFICATION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7053120 ↗
• InjuryJul 26, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN INTERVENTION IN THE VERY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY, THE GAIA THIRD GUIDE WIRE WAS USED WITH A CORSAIR CATHETER. THE GAIA THIRD WIRE WAS ADVANCED 3/4 OF THE WAY INTO THE MID TO DISTAL RCA WHEN THE PHYSICIAN PULLED THE CORSAIR CATHETER BACK. IT WAS THEN NOTED THAT THE GAIA THIRD GUIDE WIRE SEPARATED. THE PHYSICIAN SUSPECTS THAT THE TIP OF THE CORSAIR CATHETER GOT STUCK TO THE GAIA THIRD GUIDE WIRE. UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE SEPARATED WIRE. THE PATIENT WAS TAKEN TO SURGERY, BUT THE WIRE COULD NOT BE SURGICALLY REMOVED, SO IT WAS CUT LEAVING ABOUT 6 CMS OF THE WIRE IN THE CTO ARTERY. THE RCA WAS BYPASSED AS PERCUTANEOUS INTERVENTION WAS UNSUCCESSFUL IN OPENING THE CTO. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6745633 ↗