ASAHI SION AHW14R001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547327082624), received between Sep 29, 2017 and Jan 6, 2021 — classified as 5 injuries, 1 malfunction.

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.

• InjuryJan 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  SUS VOLUNTARY EVENT REPORT (MW5098059) WAS RECEIVED VIA THE US DISTRIBUTOR. IT WAS REPORTED AS FOLLOWS: "DURING A VERY DIFFICULT LAD PCI, AN INTERVENTIONAL WIRE WAS TRAPPED BY A MICROCATHETER DURING REMOVAL WHICH RESULTS IN THE DISTAL TIP OF THE WIRE SHEARING OFF AND REMAINING IN THE LAD. ATTEMPTS TO RETRIEVE THE WIRE FRAGMENT WERE UNSUCCESSFUL. THE PATIENT WAS REFERRED FOR CABG AND REMOVAL OF THE WIRE FRAGMENT INTRAOPERATIVELY."

  Patient problems: Insufficient Information

  MAUDE report 11128962 ↗
• InjuryDec 28, 2020Break; Difficult to Remove

  DURING A VERY DIFFICULT LAD PCI, AN INTERVENTIONAL WIRE WAS TRAPPED BY A MICROCATHETER DURING REMOVAL WHICH RESULTS IN THE DISTAL TIP OF THE WIRE SHEARING OFF AND REMAINING IN THE LAD. ATTEMPTS TO RETRIEVE THE WIRE FRAGMENT WERE UNSUCCESSFUL. THE PATIENT WAS REFERRED FOR CABG AND REMOVAL OF THE WIRE FRAGMENT INTRAOPERATIVELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11084764 ↗
• InjuryAug 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO ASAHI GUIDE WIRES SION AND SION BLUE WERE USED IN A PROCEDURE TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE RCA. BOTH GUIDE WIRES GOT STUCK IN AN ASAHI CORSAIR PRO MICROCATHETER. A FRAGMENT OF THE SION GUIDE WIRE CAME OFF WHILE IN THE PATIENT. IT WAS UNABLE TO REMOVE THE FRAGMENT SO THAT THE PROCEDURE HAD TO STOP TO STENT THE FRAGMENT ACROSS. THE PROCEDURE WAS RESUMED AFTER SUCCESSFULLY STENTING THE FRAGMENT. FINAL OUTCOME OF THE PATIENT WAS FINE WITHOUT ADVERSE EFFECT.

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

  MAUDE report 8933658 ↗
• MalfunctionAug 8, 2019Break; Entrapment of Device

  BOTH SION WIRES GOT STUCK IN CORSAIR PRO MICROCATHETER. FRAGMENT CAME OFF WHILE IN PATIENT AND UNABLE TO REMOVE, HAD TO STOP PROCEDURE AND STENT ACROSS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8877109 ↗
• InjuryApr 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI GUIDE WIRE WAS ADVANCED TO THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY WITHOUT ISSUE DURING A PCI TO TREAT A LESION IN THE OM2 BRANCH. A STENT WAS IMPLANTED AND POST DILATATION WAS PERFORMED. ANOTHER BALLOON DILATATION CATHETER WAS ADVANCED, BUT WAS UNABLE TO REACH THE CIRCUMFLEX. A NON-ASAHI MICRO-CATHETER WAS THEN ADVANCED TO AID IN THE ADVANCEMENT OF THE BALLOON CATHETER, BUT THE BALLOON CATHETER WAS STILL UNABLE TO CROSS. THE MICRO-CATHETER WAS REMOVED WITHOUT RESISTANCE WHEN THE ASAHI GUIDE WIRE WAS NOTED TO HAVE SEPARATED IN TWO PIECES IN THE ARTERY. THE DISTAL SEPARATED SEGMENT OF WIRE WAS FREE FLOATING IN THE PATIENT ANATOMY FROM THE LEFT MAIN TO THE DISTAL CIRCUMFLEX. THE PHYSICIAN DID NOT ATTEMPT TO RETRIEVE THE SEPARATED WIRE BECAUSE THERE WERE TWO STENTS THAT MET UP IN THE LEFT MAIN. ONE STENT WAS IN THE LAD AND THE OTHER WAS IN THE LCX. BOTH CAME TOGETHER IN SEPARATE STENTS (NO CRUSHING TECHNIQUE) IN THE LEFT MAIN; THE STENTS WERE ADJACENT TO EACH OTHER. ATTEMPTING TO PUT A SNARE IN THE LEFT MAIN WOULD RESULT IN DAMAGE TO THE STENTS. THE PATIENT LEFT THE PROCEDURE WITH THE WIRE FRAGMENT IN PLACE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 20

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem; Thrombosis

  MAUDE report 8549079 ↗
• InjurySep 29, 2017Detachment Of Device Component; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS PREVIOUSLY LINED WITH STENTS (FULL METAL JACKET). DURING ADVANCEMENT, THE ASAHI SION 180CM GUIDE WIRE BECAME STUCK AND THE TIP SEPARATED BETWEEN TWO PREVIOUSLY IMPLANTED STENTS. THE SEPARATED SEGMENT WAS EMBEDDED IN THE VESSEL AS IT WAS STENTED OVER. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA WITH DEFIBRILLATION PERFORMED. IT IS UNKNOWN IF THE VENTRICULAR TACHYCARDIA IS RELATED TO THE EVENT. THE PACEMAKER WAS REMOVED AND A BALLOON PUMP PLACED. AS OF (B)(6) 2017, THE PATIENT IS STABLE. NO ADVERSE PATIENT SEQUELAE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ventricular Tachycardia; Vessel Or Plaque, Device Embedded In

  MAUDE report 6906057 ↗