CHIKAI 008 WAIN-CKI-008-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547327098120), received between Feb 16, 2017 and Nov 27, 2021 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CHIKAI 008 GUIDE WIRE BROKE OFF IN THE RADICULAR ARTERY DURING A SPINAL ARTERIOVENOUS FISTULA (DURAL AVF) EMBOLIZATION. THE GUIDE WIRE WAS ADVANCED TO THE RADICULAR ARTERY VIA THE T10 INTERCOSTAL ARTERY IN ORDER TO DELIVER A MICROCATHETER. WHEN THE GUIDE WIRE WAS PULLED BACK THOUGH THE MICROCATHETER WITHOUT RESISTANCE, A DISTAL 1-2 CM OF THE GUIDE WIRE TIP BECAME DETACHED INSIDE THE T10 RADICULAR ARTERY. THE SEPARATED TIP WAS NOT RETRIEVED. THERE WAS NO HARM TO THE PATIENT ASSOCIATING WITH THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12879758 ↗
• MalfunctionNov 15, 2021Break

  DURING SPINAL AVF EMBOLIZATION. A DISTAL 1-2 CM TIP OF 008 WIRE BROKE INSIDE THE T10 RADICULAR ARTERY. WIRE FRAGMENT, FRAGMENT RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12817346 ↗
• MalfunctionNov 15, 2019Detachment of Device or Device Component

  PHYSICIAN ADVANCED WIRE AND HEADWAY DUO MICROCATHETER UNTIL PHYSICIAN COMMENTED THAT THE WIRE WAS NOT TORQUING ADEQUATELY. HE REMOVED THE WIRE AND THE MICROCATHETER AND NOTICED THE TIP OF THE WIRE DETACHED. WIRE AND TIP ARE BOTH AVAILABLE TO RETURN. PROCEDURE WAS COMPLETED WITH ANOTHER WIRE OF SAME MAKE AND LOT#. PATIENT WAS NOT AFFECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9326294 ↗
• MalfunctionNov 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CEREBROVASCULAR GLUE EMBOLIZATION WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. AN ASAHI GUIDE WIRE WAS ADVANCED WITH A NON-ASAHI MICROCATHETER TO THE TARGET LESION WHEN THE WIRE WAS NOT TORQUING ADEQUATELY. THE PHYSICIAN REMOVED THE WIRE AND THE MICROCATHETER AND NOTICED THE TIP OF THE WIRE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE OF THE SAME MAKE AND LOT. THERE WERE NO ADVERSE PATIENT EFFECTS RELATED TO THIS WIRE DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313305 ↗
• MalfunctionNov 17, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT DURING GUIDEWIRE ADVANCEMENT WITHIN A NON-ASAHI MICROCATHETER, RESISTANCE WAS EXPERIENCED. THE GUIDEWIRE WAS THEN REMOVED FROM THE MICROCATHETER WHEN IT WAS NOTICED DISTAL SEGMENT OF GUIDEWIRE MISSING. UNDER FLUOROSCOPY, DISTAL SEGMENT OF GUIDEWIRE WAS VISUALIZED INSIDE THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM ANATOMY WHERE DISTAL SEGMENT OF GUIDEWIRE WAS THEN RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043742 ↗
• InjuryFeb 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AVM EMBOLIZATION, AN ASAHI GUIDEWIRE WAS USED WITH A 1.3 FR. MICROCATHETER (MANUFACTURER UNKNOWN). WHEN THE GUIDEWIRE WAS ADVANCED INSIDE THE AVM FOLLOWED BY THE MICROCATHETER, THE GUIDEWIRE WOULD NOT ADVANCE NOR RETRACT INSIDE THE MICROCATHETER SO THAT BOTH DEVICES WERE REMOVED SIMULTANEOUSLY FROM THE LESION. UPON REMOVAL FROM THE LESION, UNDER FLUOROSCOPY, A LOOP OF COIL WAS INADVERTENTLY REMOVED FROM THE PREVIOUSLY EMBOLIZED LESION ALONG WITH THE GUIDEWIRE AND MICROCATHETER. AN IRREGULAR CONTOUR OR A BULBOUS SEGMENT WAS OBSERVED ON THE GUIDEWIRE APPROXIMATELY 3-5CM PROXIMAL TO THE DISTAL TIP (AS IF THE GUIDEWIRE ITSELF HAD A MARKER BAND AROUND THE WIRE). THE COIL LOOP WAS LEFT IN PLACE AND PROCEDURE WAS HALTED. THERE WAS NO HEALTH IMPACT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6337985 ↗