ASAHI SION blue AHW14R004JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327086240), received between Jan 11, 2018 and Sep 13, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI SION BLUE GUIDE WIRE HAD SEPARATED DURING A PCI TO TREAT AN IN-STENT RESTENOSIS IN THE RCA. THE EXISTING STENT WAS LONG AND PLACED JUST DISTAL TO THE OSTIUM THROUGH JUST PROXIMAL TO THE PL. NO ISSUES GETTING THROUGH THE CALCIUM AND TORTUOSITY. IVUS WAS LOADED ON THE GUIDE WIRE TO INVESTIGATE RCA OSTIUM WITH 360 CALCIFICATION. IVUS WOULD NOT CROSS. UPON TRYING TO ADVANCE IVUS, IT WAS NOTICED THAT THE GUIDE WIRE HAD SEPARATED INTO THE DISTAL PL. VARIOUS ATTEMPTS WERE MADE TO RETRIEVE THE WIRE FRAGMENTS. UPON REMOVING THE WIRE, IT WAS OBSERVED THAT A SECOND FRAGMENT WAS LEFT BEHIND IN THE DISTAL RCA. THE DECISION WAS MADE NOT TO RE-INTERVENE DUE TO EXPOSURE AND CONTRAST LOADS FROM DAY OF THE PROCEDURE. THE PATIENT IS STABLE AND KEPT FOR OBSERVATION. ANY FURTHER INFORMATION WAS NOT PROVIDED BY THE USER FACILITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12458168 ↗
• InjurySep 8, 2021Material Separation; Failure to Advance

  SION BLUE DELIVERED DOWN RCA WITH IN STENT RESTINOSIS. LONG STENT IN PLACE JUST DISTAL TO THE OSTIUM STOPPING JUST PROXIMAL TO THE PL. NO ISSUES GETTING THROUGH THE CALCIUM AND TORTUOSITY. IVUS WAS LOADED ON WIRE TO INVESTIGATE RCA OSTIUM. IVUS WOULD NOT CROSS. AT THIS TIME IT WAS NOTICED THAT THE SION BLUE WIRE HAD SEPARATED INTO THE DISTAL PL. UPON REMOVING THE WIRE IT WAS OBSERVED THAT A SECOND FRAGMENT WAS LEFT BEHIND IN THE DISTAL RCA

  Patient problems: Foreign Body In Patient

  MAUDE report 12441458 ↗
• MalfunctionJun 11, 2020Fracture; Unraveled Material; Fracture; Unraveled Material

  SUS VOLUNTARY EVENT REPORT (#MW5094427) WAS RECEIVED ON MAY 27, 2020. IT WAS REPORTED THAT THE PROCEDURE WAS GOING WELL. WIRE INSERTED CORRECTLY WITH NO PROBLEM. INTERVENTION PERFORMED AND COMPLETED WITH NO ISSUES. WIRE WAS BEING REMOVED AND RADIOGRAPHICALLY SHOWED THE WIRE WAS BEING STRETCHED, UNRAVELING. PHYSICIAN CAREFULLY MANIPULATED THE WIRE AND IT WAS REMOVED ENTIRELY. THE TARGET LESION WAS A MODERATE TO SEVERE ISR LOCATED IN OSTIAL TO PROXIMAL LAD. THERE WERE NO ISSUES ADVANCING WIRE. RESISTANCE WAS MET DURING REMOVAL AND THE WIRE WAS UNRAVELING AND STRETCHING. THE FINAL PATIENT OUTCOME WAS SUCCESSFUL ACHIEVED BY TWO DRUG ELUTING STENTS DEPLOYED AT PROXIMAL AND DISTAL PORTION ON THE EXISTING STENT AND PATIENT WAS REPORTED AS STABLE DURING AND AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141540 ↗
• MalfunctionMay 28, 2020Stretched; Unraveled Material

  PROCEDURE WAS GOING WELL. WIRE INSERTED CORRECTLY WITH NO PROBLEM. INTERVENTION PERFORMED AND COMPLETED WITH NO ISSUES. WIRE WAS BEING REMOVED AND RADIOGRAPHICALLY SHOWED THE WIRE WAS BEING STRETCHED, UNRAVELING, PHYSICIAN CAREFULLY MANIPULATED THE WIRE AND IT WAS REMOVED ENTIRELY. WIRE RETAINED WITH PACKAGING. FDA SAFETY REPORT ID (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099233 ↗
• MalfunctionJan 11, 2018Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PULMONARY ARTERY. RESISTANCE WAS FELT DURING REMOVAL OF THE GUIDE WIRE FROM THE ANATOMY WHICH RESULTED IN THE TIP COILS OF THE GUIDE WIRE STRETCHING. NO CORE SEPARATION WAS OBSERVED. ANOTHER GUIDE WIRE WAS USED SUCCESSFULLY FOR THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7182823 ↗