Astato 30 PAGH18M371Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547327088299), received between May 24, 2017 and Sep 11, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or 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 16, 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.

• MalfunctionSep 11, 2023Fracture; Fracture

  TIP OF ASTATO 30 300 CM BROKE OFF WHILE TRYING TO MANIPULATE THE WIRE THE BODY OF A HEAVILY CALCIFIED CTO OF RIGHT SFA. A 018 150 CM CXI STRAIGHT TIP CATHETER WAS USED IN ADDITION TO THE ASTATO 30 WIRE. THE CXI CATHETER WAS ABLE TO BE REMOVED INTACT, BUT THE TIP OF THE ASTATO 30 CM REMAINED STUCK IN THE OCCLUDED PORTION OF THE RIGHT SFA.

  Patient problems: Foreign Body In Patient

  MAUDE report 17726338 ↗
• InjurySep 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). WHEN AN ASAHI ASTATO 30 GUIDE WIRE WAS MANIPULATED IN THE LESION WITH THE SUPPORT OF A COOK MEDICAL CXI SUPPORT CATHETER, THE WIRE TIP DETACHED. THE CXI CATHETER WAS ABLE TO BE REMOVED INTACT, THE DETACHED WIRE TIP REMAINED STUCK IN THE OCCLUDED PORTION OF THE RIGHT SFA. AN ATTEMPT WAS MADE TO RETRIEVE THE WIRE FRAGMENT WITH A MEDTRONIC AMPLATZ GOOSE NECK, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN RESUMED AND WAS SUCCESSFULLY COMPLETED BY SHOCKWAVE AND STENTING WITH AN ABBOTT SUPERA STENT. THERE WAS NO PATIENT EFFECTS REPORTED ASSOCIATED WITH THIS EVENT. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17717028 ↗
• InjuryAug 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GUIDE WIRE BECAME SEPARATED AND REMAINED IN THE PATIENT ANATOMY DURING A PPI TO TREAT A SEVERELY CALCIFIED CTO IN THE SFA FROM OSTIAL BEAK TO HUNTER'S CANAL. A NON-ASAHI 0.035 ANGLED SUPPORT CATHETER AND THE SUBJECT 0.018 GUIDE WIRE WERE USED TO ATTEMPT TO NAVIGATE THE SEGMENT. IMAGES SHOWED THAT THE GUIDE WIRE WAS TACKING SUBINTIMAL AROUND SEVERE CIRCUMFERENTIAL CALCIFICATION. LATER IMAGES SHOWED APPROXIMATELY 3CM OF THE TIP OF THE GUIDE WIRE BROKEN OFF AND LEFT IN SITU. THE PATIENT WAS STILL ADMITTED AS OF AUGUST 10 AND CONSULTING VASCULAR SURGERY FOR POSSIBLE BYPASS AND FOREIGN BODY REMOVAL (FBR). IT WAS NOT CLEAR YET IF THE FBR IS THE PRIMARY REASON FOR VS CONSULT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7836085 ↗
• MalfunctionMay 24, 2017Break; Break

  IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION TO TREAT A MILDLY TORTUOUS LESION IN THE PROXIMAL-MID SUPERFICIAL FEMORAL ARTERY, AN ASAHI GUIDEWIRE WAS USED WITH A NON-ASAHI GUIDEWIRE CONTROLLER AND BROKE IN THE VASCULATURE. THE GUIDEWIRE WAS SUCCESSFULLY REMOVED. NO HEALTH IMPACT ON THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6589929 ↗