ASAHI SION blue AHW14R104SRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04547327133012), received between Apr 5, 2021 and Jan 26, 2026 — classified as 16 injuries, 13 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Material Separation

  USER FACILITY MEDSUN MANDATORY AND VOLUNTARY REPORT (UF REPORT #: (B)(4)) WAS RECEIVED VIA THE US DISTRIBUTOR ON JANUARY 5, 2026. IT WAS REPORTED THAT DURING A PROCEDURE FOR THE CORONARY ARTERY, AN ASAHI SION BLUE GUIDE WIRE FRACTURED. THE FRACTURED SEGMENT WAS RETRIEVED FROM THE CORONARY ARTERY. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS FINE WITHOUT ANY PROBLEMS AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24175961 ↗
• MalfunctionJan 15, 2026Material Fragmentation

  THERE WAS NO HARM TO THE PATIENT. ASAHI SION BLUE GUIDEWIRE SHEARED OFF DURING THE CORONARY CASE. THE SHEARED PORTION OF THE WIRE WAS REMOVED FROM THE CORONARY ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24088691 ↗
• MalfunctionSep 19, 2025Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material

  SION BLUE PLACED IN LAD, 2ND SION BLUE TO DIAG, BALLOON OF OSTIAL DIAG INTO LAD, STENT PLACED IN OSTIAL DIAG INTO LAD, POST DILATION OF OSTIAL DIAGONAL, PLAQUE SHIFT IN LAD, STENT PLACED IN LAD WITH PROXIMAL EDGE OF THE STENT SLIGHTLY OVERLAPPING OSTIAL DIAG, POST DILATE STENT OF LAD, FINAL PICTURE, LAD WIRE WITHDRAWN WITHOUT INCIDENT, DIAG WIRE PULLED BACK AND TIP SEPARATION WAS NOTED, MICROCATHETER WAS TRAPPED IN AND ADVANCED CAREFULLY OVER THE UNRAVELED WIRE, DISTAL TIP WAS UNABLE TO BE FULLY CAPTURED, WIRE AND MICROCATHETER WERE PULLED OUT AS A UNIT. WIRE WAS WITHDRAWN IN ITS ENTIRETY. NO WIRE PIECES WERE LEFT BEHIND. NO HARM TO THE PATIENT. DISCHARGED AS NORMAL. NOTES: IT DOES NOT APPEAR THAT THE AFFECTED WIRE WAS EVER JAILED BEHIND A STENT OR HAD TO RE-CROSS A STENT. THE TIP POSITION OF THE DIAG WIRE NEVER CHANGED ONCE IT WAS INITIALLY POSITIONED INTO THE DIAG. THE AFFECTED WIRE APPEARED TO HAVE A SMALL LOOP IN IT FOR MUCH OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23097361 ↗
• InjuryAug 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT STENT DEPLOYMENT WAS SUCCESSFULLY PERFORMED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE MILDLY CALCIFIED AND 90-99% STENOSED UNSPECIFIED SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN AN SECOND ASAHI SION BLUE GUIDE WIRE WAS ADVANCED TO MONITOR WITH THE INTRAVASCULAR ULTRASOUND SYSTEM (IVUS), THE SION BLUE GUIDE WIRE WAS CAUGHT IN THE FIRST DIAGONAL BRANCH (D1). A MICROCATHETER AND BALLOONS WERE PLACED TO REMOVE THE GUIDE WIRE, WITHOUT SUCCESS. THE STUCK SION BLUE GUIDE WIRE CAME OUT, LEAVING THE COATING AND TIP SEGMENT IN THE PATIENT ANATOMY. THE THIRD SUBJECT SION BLUE GUIDE WIRE WAS ADVANCED TO STENT THE WIRE FRAGMENT BUT PERFORATED IN THE D1, CAUSING CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED, AND A BALLOON WAS DILATED OVER THE PERFORATION SITE. THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL, WHERE A STENT WAS DEPLOYED OVER THE WIRE FRAGMENT. IT WAS REPORTED THAT THE PATIENT HAS BEEN ALREADY DISCHARGED.

  Patient problems: Perforation of Vessels

  MAUDE report 22901514 ↗
• InjuryAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT STENT DEPLOYMENT WAS SUCCESSFULLY PERFORMED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE MILDLY CALCIFIED AND 90-99% STENOSED UNSPECIFIED SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHEN THE SECOND ASAHI SION BLUE GUIDE WIRE WAS ADVANCED TO MONITOR WITH THE INTRAVASCULAR ULTRASOUND SYSTEM (IVUS), THE SUBJECT SION BLUE GUIDE WIRE WAS CAUGHT IN THE FIRST DIAGONAL BRANCH (D1). A MICROCATHETER AND BALLOONS WERE PLACED TO REMOVE THE GUIDE WIRE, WITHOUT SUCCESS. THE STUCK SION BLUE GUIDE WIRE CAME OUT, LEAVING THE COATING AND TIP SEGMENT IN THE PATIENT ANATOMY. A THIRD SION BLUE GUIDE WIRE WAS ADVANCED TO STENT THE WIRE FRAGMENT BUT PERFORATED IN THE D1, CAUSING CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED, AND A BALLOON WAS DILATED OVER THE PERFORATION SITE. THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL, WHERE A STENT WAS DEPLOYED OVER THE WIRE FRAGMENT. IT WAS REPORTED THAT THE PATIENT HAS BEEN ALREADY DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22901513 ↗
• InjuryAug 4, 2025Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS 90-99% STENOSED TRIPLE VESSEL DISEASE. THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS WIRED WITH AN ASAHI SION BLUE GUIDE WIRE AND THE HEAVILY CALCIFIED LESION IN THE LEFT CIRCUMFLEX ARTERY (LCX) WAS WIRED WITH AN ASAHI SUOH 03 GUIDE WIRE. THE LCX WAS PRE-DILATED WITH AN ORBUSNEICH SAPPHIRE BALLOON CATHETER (0.8 MM), AN UNSPECIFIED NON-COMPLIANT BALLOON (2.5 MM) AND THEN A SPECTRANETICS ANGIOSCULPT BALLOON CATHETER (2.5 MM). THE LAD WAS PRE-DILATED WITH AN UNSPECIFIED NON-COMPLIANT BALLOON (3.0 MM) AND AN ANGIOSCULPT BALLOON CATHETER (3.0 MM). TWO OVERLAPPING STENTS WERE THEN DEPLOYED FROM THE MID LAD BACK TO THE LEFT MAIN STEM (LMS), AND MODIFIED T STENTING WAS PERFORMED TO THE LCX. TWO OVERLAPPING STENTS WERE ALSO DEPLOYED FROM THE DISTAL LCX TO THE OSTIUM WITH KISSING BALLOON TECHNIQUE USING TWO UNSPECIFIED BALLOON CATHETERS (3.0 MM AND 3.5 MM) AND PROXIMAL OPTIMIZATION TECHNIQUE USING AN UNSPECIFIED NON-COMPLIANT BALLOON (5 MM) TO THE LMS. THE TIP OF THE SION BLUE GOT TRAPPED IN THE DISTAL LCX AFTER JAILED WITH LMS STENT, WHICH WAS REMOVED USING A TE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697157 ↗
• InjuryMay 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT TWO ASAHI SION BLUE GUIDE WIRES WERE USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A MODERATELY CALCIFIED 75% OR LESS STENOSIS FROM THE LEFT MAIN TRUNK TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE SION BLUE GUIDE WIRE WAS INSERTED INTO THE LAD AND THE OTHER SION BLUE GUIDE WIRE WAS INSERTED INTO THE LCX. THERE WAS A DISSECTION IN THE OSTIAL LAD AND THE GUIDE WIRE WAS UNCOILED AND FRACTURED. THE WIRE FRAGMENT EXTENDED INTO THE AORTA. LIFELONG DUAL ANTIPLATELET THERAPY WAS CONTINUED. IT WAS INFORMED THAT THE PATIENT HAD NO CONSEQUENCES AND THE BLOOD BLOW WAS FINE AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22025461 ↗
• InjuryApr 25, 2025Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE WAS USED DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A HEAVILY CALCIFIED LESION IN THE MAIN TRUCK OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO THE DIAGONAL BRANCH. DURING REMOVAL OF THE GUIDE WIRE AT THE END OF THE PROCEDURE, RESISTANCE WAS MET AT THE DISTAL SEGMENT AND THE GUIDE WIRE COULD NOT BE REMOVED. AN UNSPECIFIED MICROCATHETER WAS USED TO REMOVE THE GUIDE WIRE AS AN ADDITIONAL TREATMENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY OR ANY OTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21907034 ↗
• MalfunctionMar 7, 2025Material Fragmentation; Material Fragmentation

  TWO SION BLUE WIRES WERE USED. THE WIRE THAT WAS PLACED IN THE DISTAL SEGMENT OF THE LAD WAS LEFT PROLAPSED FOR ABOUT 15 MINUTES. WHEN PULLING THE WIRE BACK IT ENCOUNTERED CALCIUM IN THE PROXIMAL SEGMENT OF THE LAD AND THE TIP BROKE OFF. A STENT WAS PLACED TO TRAP THE FRAGMENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554264 ↗
• InjuryNov 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF AN ASAHI SION BLUE GUIDE WIRE HAD FRACTURED DURING A COMPLEX PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE HEAVILY DISEASED AND HEAVILY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). THE OSTIAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE OSTIAL LCX WAS CALCIFIED. THE SION BLUE GUIDE WIRE WAS SHAPED AND INSERTED INTO THE PATIENT ANATOMY. IT WAS DIFFICULT TO ADVANCE THE SION BLUE GUIDE WIRE INTO THE LCX DUE TO THE TIGHT CURVATURE OF THE VESSEL. THE PHYSICIAN ADVANCED THE SION BLUE GUIDE WIRE INTO THE RELATIVELY EASILY ACCESSIBLE LAD AND ADJUSTED THE TIP CURVE. WHEN AN ATTEMPT WAS MADE TO DELIVER THE SION BLUE GUIDE WIRE TO THE LCX BY PULLING THE GUIDE WIRE BACK, THE WIRE TIP WAS FRACTURED IN THE LAD. THE LENGTH OF THE WIRE FRAGMENT WAS ESTIMATED AT LESS THAN 2CM AND CLOSE TO 1CM. AN UNSPECIFIED STENT WAS DEPLOYED TO TRAP THE WIRE FRAGMENT. THE PATIENT WAS IN CARDIOGENIC SHOCK, AND DURING SUBSEQUENT REVASCULARIZATION SUFFERED CARDIAC ARREST AND DIED. THE PHYSICIAN COMMENTED THAT THE CARDIAC ARREST WAS NOT RELATED DIRECTLY TO THE WIRE FRACTURE, BUT DUE TO A NON-ASAHI SHOCKWAVE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20808846 ↗
• InjuryNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED 75-90% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA). AN ASAHISION BLUE GUIDE WIRE WAS DELIVERED TO AN UNSPECIFIED SIDE BRANCH FOR PROTECTION PURPOSE AND A NON-ASAHI STENT WAS DEPLOYED IN THE RCA. THE ANGLE BETWEEN THE RCA AND THE SIDE BRANCH WAS ABOUT 90? AND THE SION BLUE WAS 90? CURVED. DURING REMOVAL OF THE SION BLUE, PART OF THE GUIDE WIRE REMAINED BETWEEN THE VESSEL WALL AND THE STENT. THE REMOVED SION BLUE WAS FOUND FRAYED. AS THE RETAINED WIRE FRAGMENT WAS VERY THIN AND WAS TRAPPED BEHIND THE STENT, THE PHYSICIAN DECIDED TO LEAVE IT IN SITU. THE GUIDE WIRE WAS THEN REPLACED TO RESUME THE PROCEDURE. THE PATIENT WAS REPORTEDLY FINE AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18127508 ↗
• InjuryApr 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A 18MM LONG, 75% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PCI, THE DISTAL TIP OF AN ASAHI SION BLUE GUIDE WIRE FRACTURED AND WAS RETAINED IN THE PATIENT, REQUIRING SURGICAL INTERVENTION. THE GUIDE WIRE WAS PARKED IN THE DIAGONAL ARTERY TO PROTECT VESSEL WHILE TREATING THE PROXIMAL LAD, ALLOWING ACCESS TO THE DIAGONAL ARTERY IN THE EVENT THE DIAGONAL ARTERY OCCLUDED DUE TO PLAQUE SHIFT FROM STENT DEPLOYMENT IN THE LAD. AFTER STENT DEPLOYMENT, THE WIRE IN THE DIAGONAL ARTERY WAS REMOVED, BUT THE DISTAL TIP OF THE WIRE FRACTURED DURING THE PROCESS. ALTHOUGH ATTEMPTS WERE MADE TO RETRIEVE IT USING A PERCUTANEOUS TECHNIQUE, THEY WERE UNSUCCESSFUL AND IT REQUIRED SURGICAL REMOVAL. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED FROM HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841470 ↗
• InjuryApr 21, 2023Fracture; Fracture

  THE DISTAL TIP OF THE WIRE FRACTURED AND WAS RETAINED IN THE PATIENT, REQUIRING SURGICAL INTERVENTION. THIS IS ALL THE INFORMATION I HAVE AT THE MOMENT. CUSTOMER STATED THAT THE PRODUCT IS AVAILABE FOR RETURN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16792396 ↗
• InjuryMar 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO ASAHI SION BLUE GUIDE WIRES WERE USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT AN UNSPECIFIED VESSEL AND THE TIP OF ONE OF THE SION BLUE HAD SEPARATED. AFTER STENTING THE TARGET LESION, THE SION BLUE WAS JAILED AND GOT TRAPPED IN STENT STRUTS. WHEN PULLING FAIRLY HARD TO RELEASE THE GUIDE WIRE, THE WIRE TIP BECAME UNRAVELED AND WAS LEFT IN VESSEL. UNRAVELED COIL FROM THE WIRE FRAGMENT WAS HANGING OUT INTO THE AORTA. ATTEMPTS TO RETRIEVE THE FRAGMENT WITH SNARE WAS NOT SUCCESSFUL. THE PATIENT WAS TREATED WITH USUAL DAPT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16596435 ↗
• InjuryAug 25, 2022Detachment 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 DETACHED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A 100% IN-STENT RESTENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN WAS WIRING THOUGH THE LESION WHEN THE RADIOPAQUE TIP TORN APART. AN ASAHI CORSAIR MICROCATHETER WAS DELIVERED TO RETRIEVE THE SEPARATED TIP BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN DETERMINED TO LEAVE THE SEPARATED TIP IN SITU. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTERWARDS. THE PATIENT WAS DOING FINE. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15299442 ↗
• MalfunctionAug 16, 2022Break; Entrapment of Device

  (B)(6) 2022 WITH DR (B)(6). THE RADIOPAQUE TIP JUST TEARS APART AND HE LEFT THE DISTAL PART IN THE DISTAL RCA. HE TRIED TO REMOVED BUT HE COULDN'T.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15237592 ↗
• InjuryMay 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI SION BLUE CAME APART IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT PRESENTED TO THE CATH LAB IN CARDIAC ARREST AND RESUSCITATED. THE PHYSICIAN WAS WIRING THE CALCIFIED LAD WHEN THE EVENT OCCURRED. SLIGHT PRESSURE WAS APPLIED AGAINST RESISTANCE AS WITH ANY NORMAL INITIAL WIRE INTERROGATION. NOTHING OUT OF ORDINARY. THERE WAS NO RESISTANCE WHEN PULLING BACK ON THE WIRE AND IT SMOOTHLY CAME OUT LEAVING BEHIND THE TIP. A SNARE WAS USED TO RETRIEVE THE SEPARATED TIP BUT FAILED. THE SEPARATED TIP WAS RETAINED IN THE PATIENT. THE PATIENT WAS TAKEN FOR BYPASS SURGERY AND DID WELL. AFTER BYPASS SURGERY ANOTHER ATTEMPT TO RETRIEVE THE WIRE FRAGMENT WAS ATTEMPTED, BUT UNSUCCESSFUL. THE PATIENT WENT HOME AND IS DOING WELL. THE PATIENT WILL BE BROUGHT BACK TO THE LAB FOR ANOTHER ATTEMPT TO RETRIEVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14314085 ↗
• InjuryApr 28, 2022Break

  THE PATIENT PRESENTED TO THE CATH LAB IN CARDIAC ARREST AND RESUSCITATED. DR. (B)(6) WAS WIRING THE CALCIFIED LAD WHEN THE EVENT OCCURRED. DR. (B)(6) SAID THAT THERE WAS NO RESISTANCE WHEN PULLING BACK ON THE WIRE AND IT SMOOTHLY CAME OUT LEAVING BEHIND THE TIP. THE TIP OF A SION BLUE CAME APART IN A CORONARY ARTERY. THE PATIENT WENT FOR BYPASS SURGERY AND IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 14246336 ↗
• MalfunctionApr 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE HAD UNRAVELED WITH CORE FRACTURE DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A LESION IN AN UNSPECIFIED SEGMENT OF THE RIGHT CORONARY ARTERY (RCA). AFTER ROTOBLATION, AN UNSPECIFIED OVER-THE-WIRE BALLOON WAS USED TO EXCHANGE THE ROTOFLOPPY WIRE FOR THE SION BLUE. DURING THIS PROCESS, THE SION BLUE WENT INTO A SMALL BRANCH AND WAS ADVANCED OUT OF THE VESSEL. THE SION BLUE WAS THEN PULLED BACK INTO THE GUIDE CATHETER. WHEN REWIRING THE VESSEL, THE WIRE PROLAPSED AND WAS ADVANCED TO THE DISTAL PART OF THE RCA. THE SION BLUE WAS FOUND BROKEN AND UNCOILED IN THE POSTERIOR DESCENDING ARTERY (PDA), BUT COULD BE REMOVED INTACT. A CONTRAST INJECTION WAS THEN PERFORMED AND DYE STAINING WAS NOTICED IN THE MID RCA. THE INTERVENTION WAS CONTINUED WITH BALLOONING WHILE CALLING FOR A STAT ECHO TO CHECK FOR PERICARDIAL EFFUSION. UPON THEIR ARRIVAL, THE ECHO WAS DONE AND DETERMINED TO NOT HAVE ANY FLUID IN THE PERICARDIUM, SO 2 STENTS WERE PLACED. THE DYE WAS STILL PRESENT ANGIOGRAPHICALLY, SO THE GUIDE WIRE AND THE GUIDE CATHETER WERE REMOVED FROM THE VESSEL AND A FINAL ECHO WAS DONE AND CONFIRMED NORMAL. THE PATIENT WAS HELD IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14049353 ↗
• InjuryMar 29, 2022Break; Unraveled Material

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION (HTN) AND ATRIAL FIBRILLATION,TAKES COUMADIN,AND RESENT CHEST PAIN, SHORTNESS OF BREATH AND POSITIVE STRESS TEST. PROCEDURE: PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH ROTOBLATION TO RIGHT CORONARY ARTERY (RCA). THE SION BLUE WIRE BROKE AND UNCOILED INSIDE THE PATIENT IN THE DISTAL RCA. WIRE WAS REMOVED INTACT, ECHOCARDIOGRAM (ECHO) PERFORMED AND IDENTIFIED A SMALL PERFORATION TO A SMALL VESSEL WHICH SEALED ON ITS OWN. PATIENT HELD IN THE UNIT FOR 30 MINUTES FOR OBSERVATION THEN TRANSFERRED TO THE FLOOR. ADDITIONAL ECHO DONE THE SAME EVENING WITH NO NEW FINDINGS AND CONFIRMED NORMAL. NO KNOWN FURTHER HARM TO THE PATIENT. USED A 1.5 OVER THE WIRE BALLOON TO EXCHANGE THE ROTOFLOPPY WIRE FOR THE SION BLUE WIRE. DURING THIS PROCESS, THE PRODUCTS CAME OUT OF THE VESSEL AND INTO THE GUIDE CAUSING US TO REWIRE THE VESSEL. WHILE USING THE SION BLUE TO REWIRE THE VESSEL, THE WIRE PROLAPSED AND WAS ADVANCED TO THE DISTAL PART OF THE RCA; NOTICING THAT THE WIRE LOOKED MANGLED IN THE PDA, WE DID A CONTRAST INJECTION AND NOTICED DYE STAINING IN THE MID RCA. WE BEGAN BALLOONING THE VESSEL AND CONTINUED WITH THE INTERVENTION WHILE CALLING FOR A STAT

  Patient problems: Perforation

  MAUDE report 13934989 ↗
• MalfunctionMar 16, 2022Flaked; Peeled/Delaminated

  WHILE USING WIRE TO DELIVER A DEVICE, THE COATING ON WIRE BECAME FLAKY AND PEELED OFF. WIRE DO NO HARM. REMOVED WIRE FOR ANOTHER. NO PATIENT INJURY. HAVE PRODUCT -BUT NEED TO HAVE RETURN AUTHORIZE # AND ADDRESS TO WHERE TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13779240 ↗
• InjuryMar 15, 2022Break; Unraveled Material

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION (HTN) AND ATRIAL FIBRILLATION,TAKES COUMADIN, AND RESENT CHEST PAIN, SHORTNESS OF BREATH AND POSITIVE STRESS TEST. PROCEDURE: PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH ROTOBLATION TO RIGHT CORONARY ARTERY (RCA). THE SION BLUE WIRE BROKE AND UNCOILED INSIDE THE PATIENT IN THE DISTAL RCA. WIRE WAS REMOVED INTACT, ECHOCARDIOGRAM (ECHO) PERFORMED AND IDENTIFIED A SMALL PERFORATION TO A SMALL VESSEL WHICH SEALED ON ITS OWN. PATIENT HELD IN THE UNIT FOR 30 MINUTES FOR OBSERVATION THEN TRANSFERRED TO THE FLOOR. ADDITIONAL ECHO DONE THE SAME EVENING WITH NO NEW FINDINGS AND CONFIRMED NORMAL. NO KNOWN FURTHER HARM TO THE PATIENT. USED A 1.5 OVER THE WIRE BALLOON TO EXCHANGE THE ROTOFLOPPY WIRE FOR THE SION BLUE WIRE. DURING THIS PROCESS, THE PRODUCTS CAME OUT OF THE VESSEL AND INTO THE GUIDE CAUSING US TO REWIRE THE VESSEL. WHILE USING THE SION BLUE TO REWIRE THE VESSEL, THE WIRE PROLAPSED AND WAS ADVANCED TO THE DISTAL PART OF THE RCA; NOTICING THAT THE WIRE LOOKED MANGLED IN THE PDA, WE DID A CONTRAST INJECTION AND NOTICED DYE STAINING IN THE MID RCA. WE BEGAN BALLOONING THE VESSEL AND CONTINUED WITH THE INTERVENTION WHILE CALLING FOR A STAT

  MAUDE report 13769357 ↗
• MalfunctionFeb 14, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE AND CORSAIR PRO MICROCATHETER WERE USED IN A COMPLEX PERCUTANEOUS CORONARY INTERVENTION TO TREAT A VERY HEAVILY CALCIFIED LESION. THE GUIDE WIRE DETACHED DURING USE AND ENTANGLED WITH THE MICROCATHETER. A PART OF THE MICROCATHETER WAS TORN OFF WHEN IT WAS PULLED BACK. THE SEPARATED PART OF THE MICROCATHETER RETAINING IN THE LESION WAS CAUGHT ON THE GUIDE WIRE SO IT COULD BE REMOVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529547 ↗
• MalfunctionFeb 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE HAD UNRAVELED WITH CORE FRACTURE DURING A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DILATATIONS BY SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS AND STENT DEPLOYMENT WERE PERFORMED IN THE PROCEDURE. DURING REMOVAL OF THE GUIDE WIRE, THE PHYSICIAN FELT RESISTANCE AND REALIZED THAT THERE WAS A PROBLEM WITH THE DISTAL PART OF THE GUIDE WIRE. THE GUIDE WIRE HARDLY CAME OUT AND THE PHYSICIAN HAD TO PULL IT WITH FORCE IN ORDER TO REMOVE. IT COULD HAVE BEEN REMAINED IN THE PATIENT BUT FINALLY HE WAS ABLE TO REMOVE THE ENTIRE WIRE. THE REMOVED GUIDE WIRE WAS FOUND STRETCHED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PROCEDURE TOOK LONG BUT FINISHED SUCCESSFULLY. THIS HAPPED WITH TWO OTHER GUIDE WIRES (DISCARDED) FROM THE SAME BATCH USED IN THE SAME PROCEDURE. DEVICE 1 OF TWO WIRES THAT WERE DISCARDED: MFR REPORT #: 3003775027-2022-00013, DEVICE 2 OF TWO WIRES THAT WERE DISCARDED: MFR REPORT #: 3003775027-2022-00014, DEVICE 3 THAT WOULD BE RETURNING: MFR REPORT #: 3003775027-2022-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477079 ↗
• MalfunctionFeb 7, 2022Fracture; Fracture

  IT WAS REPORTED THAT AN ASAHI SION BLUE GUIDE WIRE HAD UNRAVELED WITH CORE FRACTURE DURING A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 75% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DILATATIONS BY SEMI-COMPLIANT AND NON-COMPLIANT BALLOONS AND STENT DEPLOYMENT WERE PERFORMED IN THE PROCEDURE. DURING REMOVAL OF THE GUIDE WIRE, THE PHYSICIAN FELT RESISTANCE AND REALIZED THAT THERE WAS A PROBLEM WITH THE DISTAL PART OF THE GUIDE WIRE. THE GUIDE WIRE HARDLY CAME OUT AND THE PHYSICIAN HAD TO PULL IT WITH FORCE IN ORDER TO REMOVE. IT COULD HAVE BEEN REMAINED IN THE PATIENT BUT FINALLY HE WAS ABLE TO REMOVE THE ENTIRE WIRE. THE REMOVED GUIDE WIRE WAS FOUND STRETCHED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PROCEDURE TOOK LONG BUT FINISHED SUCCESSFULLY. THIS HAPPED WITH TWO OTHER GUIDE WIRES (DISCARDED) FROM THE SAME BATCH USED IN THE SAME PROCEDURE. DEVICE 1 OF TWO WIRES THAT WERE DISCARDED: MFR REPORT #: 3003775027-2022-00013. DEVICE 2 OF TWO WIRES THAT WERE DISCARDED: MFR REPORT #: 3003775027-2022-00014. DEVICE 3 THAT WOULD BE RETURNING: MFR REPORT #: 3003775027-2022-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13477078 ↗