ASAHI Gaia Second AHW14R008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04547327094702), received between Mar 6, 2020 and Nov 28, 2022 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2022Fracture; Fracture

  GAIA SECOND BROKE OFF AT HINGE POINT IN SUBINTIMAL LAYER OF RCA. THE REST OF THE WIRE WAS REMOVED CLEANLY FROM THE CORONARY. PHYSICIAN STATED IT WAS BECAUSE HE "OVERMANIPULATED THE WIRE" AND HE "DID NOT REMOVE IT WHEN IT WAS BEGINNING TO FATIGUE."

  Patient problems: Foreign Body In Patient

  MAUDE report 15871626 ↗
• InjuryNov 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GAIA SECOND HAD BROKEN OFF AT HINGE POINT IN THE SUBINTIMAL LAYER OF THE RIGHT CORONARY ARTERY (RCA) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) WITH MILD CALCIFICATION IN THE RCA. THE REST OF THE WIRE WAS REMOVED CLEANLY FROM THE CORONARY. NO ATTEMPT WAS MADE TO RETRIEVE THE WIRE FRAGMENT AND IT WAS LEFT IN THE SUBINTIMAL LAYER. PROCEDURE WAS ENDED. THE PROCEDURE WAS NOT SUCCESSFUL. HE DECIDED TO END THE PROCEDURE AND HE TOOK THE PATIENT OFF THE TABLE VERY SHORTLY AFTER THE WIRE FRACTURE. AT THAT POINT, THE PATIENT WAS STABLE AND THERE WAS NO IMPACT TO THE PATIENT. PHYSICIAN STATED IT WAS BECAUSE HE "OVER MANIPULATED THE WIRE" AND HE "DID NOT REMOVE IT WHEN IT WAS BEGINNING TO FATIGUE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15867187 ↗
• MalfunctionNov 6, 2021Fracture; Fracture

  IT WAS REPORTED THAT AN ASAHI GAIA SECOND GUIDE WIRE BECAME ALMOST SEPARATED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO ) OF THE LEFT MAIN WITH SEVERE ANGLE. WHILE TRYING TO CROSS THE LEFT MAIN LESION, THE TIP OF THE GUIDE WIRE WAS ENGAGED IN THE LESION AND NOT MOVING. THE TIP MAY HAVE BEEN TRAPPED IN HEAVY CALCIUM AND WOULD NOT MOVE FORWARD. WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE, IT DID NOT COME OUT EASILY AND MAY HAVE BROKEN OR SEPARATED AT THE TIP. SEVERAL OTHER WIRES WERE USED DURING THE CASE AND ABLE TO CROSS THE LESION WITH ASTATO 20 AND FIELDER XT. BECAUSE OF THE ANGLE OF THE VESSEL THE LESION WAS UNABLE TO BE TREATED WITH BALLOON, STENT OR ANY OTHER TREATMENT DEVICE. NO PART OF THE WIRE WAS LEFT IN THE PATIENT, AND THE PATIENT WAS STABLE WITH NO COMPLICATIONS AT THE END OF THE CASE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756076 ↗
• MalfunctionOct 13, 2021Break; Difficult to Remove; Failure to Advance

  DR (B)(6) SAID WHILE TRYING TO CROSS LEFT MAIN LESION THE TIP OF THE GAIA 2ND WAS ENGAGED IN LESION AND NOT MOVING. THE TIP MAY HAVE BEEN TRAPPED IN HEAVY CALCIUM AND WOULD NOT MOVE FORWARD, HE STARTED TO REMOVE WIRE WHICH DID NOT COME OUT EASILY AND MAY HAVE BROKE OR SEPARATED AT TIP. PRIOR IN THE CASE HE SAID A RAIDER WIRE ALSO BROKE. DR (B)(6) USED SEVERAL WIRES DURING CASE AND WAS ABLE TO CROSS LESION WITH ASTATO 20 AND FIELDER XT. BECAUSE OF ANGLE OF VESSEL HE WAS NOT ABLE TO TREAT LESION WITH BALLOON/STENT OR ANY OTHER TREATMENT DEVICE. NO PART OF WIRE WAS LEFT IN PATIENT, AND MD STATES PATIENT WAS STABLE WITH NO COMPLICATIONS AT END OF CASE.

  Patient problems: Insufficient Information

  MAUDE report 12625633 ↗
• InjuryFeb 17, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GAIA SECOND GUIDE WIRE DETACHED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION SECONDARY TO IN-STENT RESTENOSIS (ISR CTO) IN THE MID RIGHT CORONARY ARTERY (RCA). AN ASAHI GAIA SECOND GUIDE WIRE WAS USED TO NAVIGATE THROUGH THE ISR CTO. WHEN THE WIRE REACHED THE DISTAL CAP, THE WIRE WAS TORQUED MULTIPLE TIMES TO ADVANCE DOWN THE DISTAL VASCULATURE BUT THE TIP WOULD NOT RESPOND. WHEN RETRACTING THE WIRE, THE CORE OF THE WIRE CAME OUT BUT THE TIP DID NOT RETRACT WITH THE WIRE. SPRING COIL WAS ATTACHED TO THE CONCOMITANT MAMBA MICROCATHETER. CATHETER AND WIRE TIP WERE REMOVED TOGETHER. NO FRAGMENTS LEFT BEHIND. CTO INTERVENTION WAS NOT SUCCESSFUL BUT PATIENT RECOVERED WELL AND WAS DISCHARGED HOME LATER IN THE EVENING. THE PHYSICIAN COMMENTED THAT WITH ALL THE TORQUEING SOMEHOW THE WIRE GOT TRAPPED ON THE END OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336417 ↗
• MalfunctionFeb 4, 2021Retraction Problem; Device Slipped; Failure to Advance

  MONGO WAS ATTEMPTED WITHOUT SUCCESS, SO A GAIA SECOND WAS USED TO NAVIGATE THROUGH THE ISR CTO. WHEN THE WIRE REACHED THE DISTAL CAP, THE WIRE WAS TORQUED MULTIPLE TIMES TO ADVANCE DOWN THE DISTAL VASCULATURE BUT THE TIP WOULD NOT RESPOND. WHEN RETRACTING THE WIRE, THE CORE OF THE WIRE CAME OUT BUT THE TIP DID NOT RETRACT WITH THE WIRE. SPRING COIL WAS ATTACHED TO THE MAMBA MICROCATHETER. CATHETER AND WIRE TIP WERE REMOVED TOGETHER. NO FRAGMENTS LEFT BEHIND.

  Patient problems: Insufficient Information

  MAUDE report 11283079 ↗
• InjuryMar 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GAIA SECOND GUIDE WIRE SEPARATED DURING A PCI TO TREAT A CTO (IN-STENT RESTENOSIS) IN THE MID RCA. WHILE THE PHYSICIAN WAS ATTEMPTING TO WIRE THE VESSEL, THE WIRE APPEARED TO GET STUCK BEHIND AN EXISTING STENT. HE PULLED THE WIRE BACK, BUT THE DISTAL PORTION OF THE WIRE BROKE UP AND REMAINED STUCK IN THE STENT AND IN THE BODY. THE REMAINDER OF THE WIRE WAS REMOVED AND SEVERAL ATTEMPTS TO SNARE THE REMAINDER OF THE WIRE WERE UNSUCCESSFUL. THE PROCEDURE WAS ABORTED AFTER MULTIPLE FAILED SNARE ATTEMPTS. THE PATIENT WAS RELEASED FROM THE HOSPITAL DOING WELL AND PLANNED FOR BYPASS SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 9851808 ↗
• InjuryMar 6, 2020Break

  PATIENT CAME TO THE CATH LAB FOR A CTO (CHRONIC TOTAL OCCLUSION) PROCEDURE AND WHILE DR. WAS ATTEMPTING TO WIRE THE VESSEL, THE WIRE APPEARED TO GET STUCK BEHIND AN EXISTING STENT. DR. PULLED THE WIRE BACK, BUT THE DISTAL PORTION OF THE WIRE BROKE UP AND REMAINED STUCK IN THE STENT AND IN THE BODY. THE REMAINDER OF THE WIRE WAS REMOVED AND SEVERAL ATTEMPT TO SNARE THE REMAINDER OF THE WIRE WERE UNSUCCESSFUL. PATIENT WAS TAKEN OF THE TABLE AND WILL HAVE BYPASS SURGERY.

  Patient problems: No Code Available

  MAUDE report 9803086 ↗