ASAHI SION blue AHW14R004SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04547327086226), received between Aug 18, 2017 and Jan 21, 2021 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO ASAHI SION BLUE GUIDE WIRES FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS 75-90% IN-STENT RESTENOSIS. ACCORDING TO A CARDIAC CATHETERIZATION TECHNICIAN, THEY HAD ISSUES SEEDING A JR4 GUIDE INTO THE OSTIUM THAT WAS WHAT CAUSED THE PROBLEM. A NON-ASAHI GUIDE WIRE WAS FIRST DELIVERED TO THE LESION IN ATTEMPTS TO CROSS BUT FAILED. THE SION BLUE GUIDE WIRE WAS THEN DELIVERED. WHILE BACKING IT OUT THROUGH THE STENT, THE GUIDE WIRE BECAME FRACTURED. ANOTHER SION BLUE (FROM THE SAME LOT) WAS REPLACED TO CONTINUE THE PROCEDURE; HOWEVER, THE SECOND SION BLUE ALSO BECAME FRACTURED. BOTH PIECES OF WIRE WERE UNABLE TO BE SNARED AND LOCATED IN DIFFERENT COLLATERAL BRANCHES DISTAL OF THE STENT THAT WERE DEEMED NOT VITAL. THE PHYSICIAN ABORTED PROCEDURE AND REMOVED ALL EQUIPMENT. THE PATIENT DID RECOVER AND SHE WAS DISCHARGED 3 DAYS AFTER THE EVENT. THIS FIRST SION BLUE IS REPORTED AS MFR REPORT #: 3003775027-2021-00011. THE SECOND SION BLUE IS REPORTED AS MFR REPORT #: 3003775027-2021-00012.

  Patient problems: Foreign Body In Patient

  MAUDE report 11206296 ↗
• InjuryJan 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO ASAHI SION BLUE GUIDE WIRES FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS 75-90% IN-STENT RESTENOSIS. ACCORDING TO A CARDIAC CATHETERIZATION TECHNICIAN, THEY HAD ISSUES SEEDING A JR4 GUIDE INTO THE OSTIUM THAT WAS WHAT CAUSED THE PROBLEM. A NON-ASAHI GUIDE WIRE WAS FIRST DELIVERED TO THE LESION IN ATTEMPTS TO CROSS BUT FAILED. THE SION BLUE GUIDE WIRE WAS THEN DELIVERED. WHILE BACKING IT OUT THROUGH THE STENT, THE GUIDE WIRE BECAME FRACTURED. ANOTHER SION BLUE (FROM THE SAME LOT) WAS REPLACED TO CONTINUE THE PROCEDURE; HOWEVER, THE SECOND SION BLUE ALSO BECAME FRACTURED. BOTH PIECES OF WIRE WERE UNABLE TO BE SNARED AND LOCATED IN DIFFERENT COLLATERAL BRANCHES DISTAL OF THE STENT THAT WERE DEEMED NOT VITAL. THE PHYSICIAN ABORTED PROCEDURE AND REMOVED ALL EQUIPMENT. THE PATIENT DID RECOVER AND SHE WAS DISCHARGED 3 DAYS AFTER THE EVENT. ON (B)(6), 2022, THE USER FACILITY MEDWATCH REPORT (UF REPORT #: (B)(4) WAS RECEIVED VIA THE US IMPORTER. OBTAINED ADDITIONAL INFORMATION WAS AS FOLLOWS: TYPE OF PROCEDURE: THROMBECTOMY, INTRACORONARY INFUSION OF INTEGRILIN AND BALLOON EVENT INFORMATION: PATIENT

  Patient problems: Foreign Body In Patient

  MAUDE report 11206293 ↗
• InjuryJan 6, 2021Fracture

  TWO SION BLUE WIRES FRACTURED DURING THIS PROCEDURE. ACCORDING TO CATH TECH THEY HAD ISSUES SEEDING THE JR4 GUIDE INTO OSTIUM. SHE SHOWED ME PICTURE OF BOTH THE GUIDELINER AND PTCA BALLOON AND THEY LOOKED MANGLED AFTER BEING REMOVED FROM THE BODY.

  Patient problems: Insufficient Information

  MAUDE report 11128216 ↗
• InjuryJan 6, 2021Fracture

  TWO SION BLUE WIRES FRACTURED DURING THIS PROCEDURE. ACCORDING TO CATH TECH THEY HAD ISSUES SEEDING THE JR4 GUIDE INTO OSTIUM. SHE SHOWED ME PICTURE OF BOTH THE GUIDELINER AND PTCA BALLOON AND THEY LOOKED MANGLED AFTER BEING REMOVED FROM THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11127823 ↗
• MalfunctionDec 15, 2020Material Frayed

  PHYSCIAN COMMENT ACCORDING TO NURSE REPORT GIVEN TO ME OVER THE PHONE: "THE WIRE COMPLETELY FRAYED ON ME AND ITS ALL MANGLED UP" THIS IS A VERY EXPERIENCED SION BLUE USER WHO HAS NEVER ENCOUNTERED DIFFICULTIES WITH THE WIRE IN THE PAST.

  Patient problems: Insufficient Information

  MAUDE report 11008511 ↗
• InjuryFeb 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COMPLICATED CHRONIC TOTAL OCCLUSION CORONARY PROCEDURE, ONE OF THE INTERVENTIONAL WIRES INCLUDING THIS GUIDE WIRE BECAME SHEARED OFF AND A SMALL FLEXIBLE PORTION REMAINED IN THE PATIENT'S SEPTAL VESSEL. NO INFORMATION REGARDING REMEDIAL ACTION AGAINST THE SEPARATED TIP WAS OBTAINED.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 8342250 ↗
• InjuryJan 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SEVERELY CALCIFIED CTO OF THE RCA. AN ASAHI GUIDE WIRE WAS NAVIGATED THROUGH THE LAD SEPTAL COLLATERALS. THE CALCIFIED, TORTUOUS VESSELS CAUSED THE GUIDE WIRE TO SHEAR. A PERFORATION OCCURRED, DRAINING INTO THE RIGHT SINUS; HOWEVER, IT DID SEAL ITSELF BEFORE THE END OF THE CASE. CROSSING THE CTO WAS NOT ACCOMPLISHED, THE CASE ENDED WITH NO PATIENT DISCOMFORT OR COMPLICATIONS. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 8288032 ↗
• MalfunctionJan 28, 2019Break

  DURING A COMPLICATED CHRONIC TOTAL OCCLUSION CORONARY PROCEDURE, ONE OF THE INTERVENTIONAL WIRES BECAME SHEARED OFF AND A SMALL FLEXIBLE PORTION REMAINS IN THE PATIENTS SEPTAL VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8280904 ↗
• InjurySep 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT CORONARY ARTERY (RCA), THE GUIDE WIRE TIP SEPARATED/DETACHED WHEN TRYING TO REMOVE THE DEVICE AT THE END OF THE PROCEDURE; THE TIP FRAGMENT REMAINS INSIDE THE RCA BRANCH VESSEL. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2018.

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

  MAUDE report 7858956 ↗
• InjurySep 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE UNSPECIFIED VESSEL, THE GUIDE WIRE TIP BECAME DETACHED/SEPARATED. THE GUIDE WIRE AND FRAGMENT WERE SUCCESSFULLY REMOVED FROM THE ANATOMY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7858955 ↗
• MalfunctionFeb 2, 2018Detachment Of Device Component; Stretched

  IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE WAS SELECTED FOR THE PROCEDURE. UPON REMOVAL OF THE ASAHI SION BLUE GUIDE WIRE FROM THE ANATOMY, THE TIP COILS WERE OBSERVED TO BE UNRAVELED (STRETCHED). THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED. RETURNED GOODS ANALYSIS FOUND THAT THE CORE OF THE GUIDE WIRE WAS SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7238948 ↗
• MalfunctionJan 23, 2018Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE MILDLY TORTUOUS, HEAVILY CALCIFIED, DISTAL CIRCUMFLEX (CX) CORONARY ARTERY. A SION BLUE GUIDE WIRE WAS SELECTED FOR THE PROCEDURE. A NON-ABBOTT MICROCATHETER WAS ADVANCED OVER THE GUIDE WIRE AND WHILE TRYING TO CROSS THE LESION RESISTANCE WAS FELT WITH THE GUIDE WIRE. AN UN SUCCESSFUL ATTEMPT WAS MADE TO WITHDRAW THE MICROCATHETER FROM THE ANATOMY OVER THE GUIDE WIRE. THEREFORE, THE GUIDE WIRE AND THE MICROCATHETER WERE REMOVED FROM THE ANATOMY AS A UNIT. UPON REMOVAL FROM THE ANATOMY, AN UNSUCCESSFUL ATTEMPT WAS MADE TO WITHDRAW THE GUIDE WIRE FROM THE MICROCATHETER AND IT WAS FOUND THAT THE GUIDE WIRE WAS STUCK INSIDE THE MICROCATHETER. A NEW SION BLUE GUIDE WIRE AND MICROCATHETER WERE ADVANCED TO THE LESION AND DUE TO THE SEVERITY OF THE LESION, WOULD NOT CROSS. THE PROCEDURE WAS STOPPED AT THAT POINT. THE PATIENT WAS DISCHARGED AFTER A NORMAL RECOVERY TIME. A DECISION WILL BE MADE LATER AS TO WHETHER TO BRING THE PATIENT BACK FOR ANOTHER PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7212717 ↗
• MalfunctionJan 15, 2018Break; Break

  IT WAS REPORTED THAT DURING A CORONARY CTO OF THE DISTAL CIRCUMFLEX ARTERY, A LESION CAP WAS ENGAGED WITH THE SUBJECT GUIDE WIRE AND PASSED WITH SOME EFFORT. A MICROCATHETER WAS ADVANCED OVER THE SUBJECT GUIDE WIRE TO THE CAP WHERE IT WAS USED IN THE NORMAL FASHION. OVER THE COURSE OF TRYING TO CROSS THE LESION, THE PHYSICIAN NOTICED THAT THE CONCOMITANT MICROCATHETER WAS DRAGGING ON THE SUBJECT GUIDE WIRE; AN ATTEMPT TO WITHDRAW IT WAS UNSUCCESSFUL. IT WAS DETERMINED THAT BOTH OF THE MICROCATHETER AND GUIDE WIRE WERE REMOVED AS A UNIT. UPON REMOVAL OF THE SYSTEM, AN ATTEMPT WAS MADE TO WITHDRAW THE SUBJECT GUIDE WIRE OUT OF THE CONCOMITANT MICROCATHETER, BUT IT WAS UNSUCCESSFUL. A SECOND CATHETER AND A GUIDE WIRE WERE USED BUT DUE TO THE SEVERITY OF THE LESION, THE LESION COULD NOT BE CROSSED. THE DYE COUNT WAS REACHING THE AMOUNT WHERE THE CASE HAD TO BE STOPPED. NO ILL EFFECTS WERE OBSERVED AND A DECISION WILL BE MADE TO SEE IF THE PATIENT WILL BE BROUGHT BACK LATER. THE PATIENT WAS DISCHARGED AFTER NORMAL RECOVERY TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7190056 ↗
• InjurySep 7, 2017Detachment Of Device Component

  SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ASAHI RECEIVED A USER FACILITY MEDWATCH REPORT FROM FDA. AFTER FOLLOW-UP WITH THE PHYSICIAN, THE MEDWATCH REPORT INFORMATION IS CORRECT. THE CORONARY WAS PERFORATED AND BLOOD FLOW WAS OCCLUDED, HOWEVER THE PATIENT WAS STABILIZED AFTER BALLOONED WITH A LONG INFLATION AND STENTING WITH A NON-ABBOTT STENT. THE PATIENT DATE OF BIRTH IS (B)(6) 1949 THE PATIENT IS (B)(6) YEARS OLD.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6849954 ↗
• MalfunctionAug 18, 2017Difficult To Position; Difficult to Remove; Physical Property Issue

  IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT THAT THE FOLLOWING ISSUE OCCURS WITH ASAHI SION BLUE 300CM GUIDE WIRE. THE COATING ON THE GUIDE WIRE BECOMES STICKY AFTER PROLONGED AND EVERY DEVICE (UNSPECIFIED BALLOONS AND MULTIPLE OTHER UNSPECIFIED TYPES OF DEVICES) THAT IS USED OVER THE GUIDE WIRES BECOMES STUCK (UNABLE TO ADVANCE OR RETRACT) AND CAUSES GUIDE WIRE POSITIONING IN THE ANATOMY TO BE LOST. THE GUIDE WIRE WAS REPLACED WITH OTHER UNSPECIFIED GUIDE WIRE BRANDS TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803398 ↗
• MalfunctionAug 18, 2017Difficult To Position; Difficult to Remove; Physical Property Issue

  IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT THAT THE FOLLOWING ISSUE OCCURS WITH ASAHI SION BLUE 180 CM GUIDE WIRE. THE COATING ON THE GUIDE WIRE BECOMES STICKY AFTER PROLONGED AND EVERY DEVICE (UNSPECIFIED BALLOONS AND MULTIPLE OTHER UNSPECIFIED TYPES OF DEVICES) THAT IS USED OVER THE GUIDE WIRES BECOMES STUCK (UNABLE TO ADVANCE OR RETRACT) AND CAUSES GUIDE WIRE POSITIONING IN THE ANATOMY TO BE LOST. THE GUIDE WIRE WAS REPLACED WITH OTHER UNSPECIFIED GUIDE WIRE BRANDS TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803389 ↗