ASAHI Gladius Mongo18 PV ES PP18R304SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547327143219), received between Apr 22, 2024 and Jun 6, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 18 PV ES GUIDE WIRE WAS USED IN THE KNUCKLE WIRE TECHNIQUE DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO CROSS A MODERATELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). WHEN THE KNUCKLED GUIDE WIRE WAS INSERTED TOGETHER WITH AN ANGLED 90CM NAVICROSS SUPPORT CATHETER (TERUMO) IN THE VESSEL, THE DISTAL SEGMENT OF THE GUIDE WIRE WAS DAMAGED. THE GUIDE WIRE WAS EXCHANGED FOR AN ASAHI GRAND SLAM GUIDE WIRE, AND DIRECTIONAL ATHERECTOMY AND DEPLOYMENT OF A SELF-EXPANDABLE STENT WERE PERFORMED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE DEVICES WITH A SPIDER FILTER WIRE (MEDTRONIC), THE FILTER WIRE GOT TANGLED WITH THE STENT STRUT, DAMAGING THE STRUT. THEN THE SUBJECT GLADIUS MONGO 18 PV ES GUIDE WIRE WAS AGAIN USED TO DELIVER AN UNSPECIFIED BALLOON CATHETER THROUGH A STENT STRUT. DURING WITHDRAWAL OF THE SUBJECT GUIDE WIRE, THE DAMAGED DISTAL SEGMENT WAS GOT TANGLED WITH THE DAMAGED STENT STRUT, CAUSING THE CORE WIRE OF THE GUIDE WIRE TO BE DETACHED FOR APPROXIMATELY 1CM AND LEFT IN THE PATIENT ANATOMY. THE WIRE FRAGMENT WAS REMOVE WITH AN UNSPECIFIED SNARE BY WAY OF AN UNSPECIFIED 6F GUIDING CATHETER AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19474240 ↗
• InjuryJun 5, 2024Break; Break

  MONGO 18 WIRE WAS USED TO KNUCKLE & CROSS SFA CTO APPROXIMATELY 100CM LONG. KNUCKLED WIRE WAS PUSHED WITH 90CM ANGLED NAVICROSS & TIP SUSTAINED MODERATE DAMAGE AND BECAME MISSHAPEN. MONGO WAS EXCHANGED FOR GRAND SLAM AND LESION WAS TREATED WITH DIRECTIONAL ATHERECTOMY AND SELF-EXPANDING STENT. STENT STRUTS WERE DAMAGED WHEN SPIDER FILTER WIRE BECAME TANGLED IN STRUTS UPON CAPTURE AND REMOVAL. MONGO WAS USED LATER IN PROCEDURE TO DELIVER .018 DIAMETER SHAFT BALLOONS THROUGH DAMAGED STENT STRUTS. WHILE TRYING TO REMOVE MONGO, THE DAMAGED TIP BECAME TANGLED IN THE DAMAGED STENT STRUTS AND APPROXIMATELY 1CM WAS SEPARATED FROM REST OF CORE WIRE IN THE BODY. THE TIP FRAGMENT WAS THEN REMOVED USING A GOOSE-NECK SNARE THROUGH A 6FR GUIDE CATHETER AND LONG 6FR SHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 19473194 ↗
• InjuryApr 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT RETROGRADE ATTEMPTS WERE MADE BUT FAILED TO CROSS A MILDLY CALCIFIED AND 100%-OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) BEFORE ATHERECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE APPROACH WAS CHANGED TO ANTEGRADE FROM THE COMMON FEMORAL ARTERY (CFA). WHEN INSERTION TO THE PROXIMAL CAP WAS ATTEMPTED WITH AN ASAHI GLADIUS MONGO 18 PV ES, THE GUIDE WIRE WAS FOUND TWISTED. AFTER REMOVAL FROM THE PATIENT ANATOMY, A PART OF THE GUIDE WIRE WAS FOUND STILL LEFT IN THE CONCOMITANTLY USED NAVICROSS SUPPORT CATHETER (TERUMO). THE SUPPORT CATHETER WAS REMOVED FROM THE PATIENT ANATOMY AND ATTEMPTS WERE MADE TO PUSH THE GUIDE WIRE FRAGMENT OUT FROM THE CATHETER LUMEN. THE OUTER COIL OF THE GUIDE WIRE CAME OUT ONTO THE TABLE. IT WAS INFORMED THAT THERE WERE NO GUIDE WIRE FRAGMENTS LEFT IN THE PATIENT ANATOMY AFTER THE PROCEDURE. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED AFTER THE LESION WAS CROSSED. IT WAS ALSO INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19170217 ↗
• MalfunctionApr 22, 2024Fracture; Fracture

  ACCESSED THE POSTERIOR TIBIAL ARTERY AND ATTEMPTED TO CROSS RETROGRADE FASHION. UNSUCCESSFUL SO WE STUCK ANTEGRADE COMMON FEMORAL ARTERY AND ATTEMPTED TO CROSS IS THAT FASHION. TRIED TO ENGAGE THE MEDIAL TRACT OF THE PROXIMAL CAP AND THE WIRE TWISTED AROUND ITSELF. AT THAT POINT WE REMOVED THE WIRE AND NOTICED THERE WAS STILL SOME OF THE TIP OF THE NAVICROSS. WE REMOVED THE NAVICROSS AND PUSHED THE REMAINING PORTION OF THE WIRE OUT OF THE CATHETER AND YOU COULD SEE THE ACT FALL APART ON THE TABLE. NO PARTS REMAINED IN THE PATIENTS BODY AFTER THE PROCEDURE. CONTINUED WITH THE PROCEDURE AND CROSSED LESION AND TREATED AND HAD A SUCCESSFUL CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160959 ↗