ViperWire GWC-12325LG-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 10852528005701), received between Dec 6, 2019 and Sep 24, 2026 — classified as 8 deaths, 143 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (140 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 157 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Material Separation; Improper or Incorrect Procedure or Method

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 50890507 ↗
• InjuryJul 20, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, NON-TORTUOUS, 85% STENOSED LESION IN PROXIMAL TO MID CIRCUMFLEX ARTERY (CFX). THE CFX WAS PRIMARILY WIRED WITH A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WHICH WAS POSITIONED GENEROUSLY DISTAL TO THE LESION. THERE WAS NO WIRE BIAS. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. SETUP OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS COMPLETED AND 4 ANTEGRADE, PROXIMAL-TO-DISTAL TREATMENTS WERE SUCCESSFULLY PERFORMED. A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND THE VIPERWIRE WAS REMOVED. AS A PUFF OF CONTRAST WAS MADE THE TIP OF THE VIPERWIRE CAME INTO SIGHT. WITH THE INJECTION THE TIP CAME FROM THE GUIDE WIRE AND LANDED HALFWAY OUT OF THE TIP OF GUIDE WIRE AND HALF INTO THE OSTIUM OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). EXAMINATION OF THE FRACTURED VIPERWIRE CONFIRMED IT WAS THE SPRING TIP. A SNARE WAS USED TO SUCCESSFULLY EXTRACT THE TIP WHICH REMAINED IN THE SNARE DEVICE. SUCCESSFUL STENT PLACEMENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE OAD TIP BUSHING NEVER CAME ANYWHERE CLOSE TO THE RADIOPAQUE TIP OF THE VIPERWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874260 ↗
• InjuryJun 3, 2026Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT PROXIMAL LEFT ANTERIOR DESCENDING (LAD) HIGHLY CALCIFIED, NON-TORTUOUS LESION, A NON-ABBOTT WIRE WAS INSERTED VIA THE RIGHT FEMORAL ARTERY THROUGH AN EBU 3.5 GUIDE CATHETER. A 2.5 X 15 SAPPHIRE BALLOON WAS INSERTED OVER NON-ABBOTT WIRE AND INFLATED PROXIMAL. A NON-ABBOTT CATHETER WAS INSERTED OVER THE WIRE AFTER THE BALLOON WAS REMOVED. THE NON-ABBOTT WIRE WAS REMOVED AND VIPERWIRE CORONARY FLEX GUIDEWIRE WAS INSERTED THROUGH THE NON-ABBOTT CATHETER. SEVERAL TREATMENTS RUNS WERE PERFORMED SUCCESSFULLY AT 80,000 RPM. IT APPEARED THAT THE GUIDEWIRE DISTAL TIP WAS SEPARATED FROM THE BODY OF THE WIRE AND LEFT IN THE DISTAL DIAGONAL VESSEL. A NON-ABBOTT CATHETER WAS INSERTED OVER THE VIPERWIRE GUIDEWIRE FLEX TIP AND THEN IT WAS NOTICED THAT THE CATHETER WAS NEXT TO THE VIPERWIRE GUIDEWIRE TIP. AT THIS POINT, THE PHYSICIAN REALIZED THAT THE TIP OF THE WIRE WAS SEPARATED. THE END OF VIPERWIRE CORONARY GUIDEWIRE HAD SHEARED OFF IN DISTAL LAD NEAR APEX AND APPROXIMATELY 30 MM RADIO PLAQUE TIP OF THE GUIDEWIRE WAS LEFT IN-VIVO. A NON-ABBOTT WIRE WAS INSERTED WIRE THOUGH THE NON-ABBOTT CATHETER AND THE PROCEDURE WAS CONTINUED USING A 2.25X18 SKYP

  Patient problems: Foreign Body In Patient

  MAUDE report 25374158 ↗
• InjuryMay 8, 2026Material Separation; Device Damaged by Another Device

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A FIBROCALCIFIC OBTUSE MARGINAL (OM) 2. IT WAS INDICATED AN UNSPECIFIED BALLOON CROSSED THE LESION BUT DID NOT YIELD TO DILATION. THREE TO FOUR ANTEGRADE TREATMENTS WERE PERFORMED WITH SHORT BACKWARD MOVEMENT TO RE-ADVANCE THE OAD. DURING THE PROCEDURE, THE VIPERWIRE GUIDE WIRE FRACTURED. THERE WAS NO INDICATION AS TO WHAT LED TO THE FRACTURE. THE FRACTURED TIP REMAINED IN-VIVO IN THE FAR DISTAL VESSEL AND WAS NOT RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. THE DATE OF THE PROCEDURE IS AN ESTIMATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25126609 ↗
• DeathApr 24, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED DISTAL LEFT MAIN (LM)/OSTIAL LEFT CIRCUMFLEX (CX). THE PATIENT WAS GIVEN HEPARIN PRIOR TO ORBITAL ATHERECTOMY, AND AN IMPELLA CP WAS PLACED IN THE PATIENT'S RIGHT FEMORAL ARTERY. A SINGLE ACCESS 7FR SHEATH AND GUIDE SYSTEM WAS UTILIZED. A NON-ABBOTT INTERVENTIONAL WIRE, ALONG WITH A NON-ABBOTT MICROCATHETER, WERE USED TO GET ACROSS THE LESION INITIALLY. THE VIPERWIRE GUIDE WIRE WAS ABLE TO BE EXCHANGED IN. THERE WERE NO APPARENT ISSUES DURING PREPARATION OF THE OAD. THE OAD WAS SUCCESSFULLY LOADED ONTO THE VIPERWIRE, AND ADVANCED JUST PROXIMAL TO THE LESION. A LOW-SPEED TREATMENT WAS PERFORMED FOR FIVE SECONDS, AS THE GUIDE CATHETER WAS PUSHING OUT AND THERE WAS DIFFICULTY REMAINING ENGAGED. IT WAS DETERMINED AT THIS TIME THAT THE PHYSICIAN WAS TO USE GLIDEASSIST MODE TO GET CLOSER TO THE LESION AND HELP SEAT THE GUIDE CATHETER BETTER. GLIDEASISST MODE WAS USED TO GET THE OAD NEXT TO THE LESION BETTER. DURING THIS TIME, THE BRAKE LEVER WAS NOT ENGAGED, AS THEY WERE MOVING THE ENTIRE OAD AT THE TIME. THE BRAKE LEVER WAS LOCKED PRIOR

  Patient problems: Cardiac Arrest; Foreign Body In Patient; Perforation of Vessels; Vascular Dissection

  MAUDE report 24984313 ↗
• InjuryApr 20, 2026Material Separation

  IT WAS REPORTED THAT RIGHT AND LEFT FEMORAL ACCESS WAS OBTAINED TO PLACE A NON-ABBOTT DEVICE PRIOR TO START OF THE PROCEDURE. HEPARIN WAS USED FOR ANTICOAGULATION AND ACTIVATED CLOTTING TIMES (ACTS) WERE CONFIRMED THERAPEUTIC AND MONITORED. A NON-ABBOTT WIRE WAS PLACED INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND EXCHANGED OVER 2.0 OTW BALLOON FOR THE VIPERWIRE CORONARY GUIDEWIRE. A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH A VIPERWIRE CORONARY GUIDEWIRE DURING ATHERECTOMY PROCEDURE TO TREAT 80% STENOSED HEAVILY CALCIFIED CIRCUMFLEX ARTERY. ORBITAL ATHERECTOMY WAS COMPLETED FROM THE LEFT MAIN (LM) TO PROXIMAL LAD SUCCESSFULLY. THE VIPERWIRE GUIDEWIRE WAS REMOVED AND A NON-ABBOTT WIRE WAS ADVANCED INTO THE DISTAL LEFT CIRCUMFLEX. IT WAS THEN EXCHANGED FOR THE VIPERWIRE GUIDEWIRE VIA A TWIN PASS CATHETER. ATHERECTOMY WAS PERFORMED IN THE PROXIMAL CIRCUMFLEX. THE TIP OF THE WIRE WAS SHEARED OFF INTO THE DISTAL LEFT CIRCUMFLEX. 3 CM OF THE WIRE WAS LEFT IN-VIVO. ATTEMPTING TO REWIRE THE LEFT CIRCUMFLEX IN ORDER TO CAPTURE THE WIRE OR STENT IT AGAINST THE WALL WAS DIFFICULT. THE PATIENT EXPERIENCED TACHYCARDIA AND UNSTABLE LEADING TO PULSELESS ELECTRICAL

  Patient problems: Cardiac Arrest; Foreign Body In Patient; Perforation of Vessels; Pericardial Effusion; Tachycardia

  MAUDE report 24933512 ↗
• InjuryMar 31, 2026Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE OAD WAS ADVANCED TOO CLOSE TO THE VIPERWIRE GUIDE WIRE SPRING TIP, WHICH LED TO THE VIPERWIRE FRACTURING. THE FRACTURED COMPONENT WAS ABLE TO BE SNARED. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750377 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 95% STENOSED SEVERELY CALCIFIED TIGHT MID RIGHT CORONARY ARTERY LESIONS WITH MILD TORTUOSITY, A NON-ABBOTT 6F GUIDE WAS USED TO PRIMARILY WIRE THE VESSEL WITH VIPERWIRE ADVANCE CORONARY GUIDEWIRE. THE VESSEL WAS 2.75-3.0MM IN DIAMETER AND 50 MM IN LENGTH. THE VESSEL WAS PREPPED AND A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED JUST PROXIMAL TO THE LESION. WITHIN THE SPECIFIC AREA/LESION THAT WAS BEING TREATED, THERE WERE TWO TIGHTER SPOTS. TWO TREATMENTS WERE PERFORMED WITHOUT ANY JUMP FOR APPROXIMATELY 27 SECONDS ALL THE WAY TO THE END OF THE PLANNED TREATMENT AREA. THE TREATMENT WAS PAUSED 1:1 AND THEN TREATMENT WAS PERFORMED FOR APPROXIMATELY 27 SECONDS. THE TREATMENT WAS RESTED 1:1 AND REPEATED THRICE. THERE WERE PUFFS TAKEN BETWEEN RUNS TO MAKE SURE VESSEL REMAINED OPEN AND THERE WERE NO ISSUES. OCCASIONAL PUFFS OF CONTRAST TAKEN BETWEEN TREATMENTS. AT THE END OF THE LAST TREATMENT, THE PATIENT'S HEART RATE SLOWED. IT WAS NOTED THAT THE PATIENT ALREADY HAD A SLOW HEART RATE, THEREFORE TEMPORARY PACER WAS PLACED AT THE BEGINNING AND PACER SETTING WERE ESTABLISHED AT THE BEGINNING. THE PACER KICK

  Patient problems: Ischemia; Non specific EKG/ECG Changes; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 24700017 ↗
• DeathFeb 20, 2026Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "THE PROCEDURE BEGAN AS A DIAGNOSTIC LEFT HEART CATH. DURING THE ATTEMPTED ORBITAL ATHERECTOMY OF THE CIRCUMFLEX, THE DIAMONDBACK CATHETER WAS UNABLE TO CROSS THE LESION. A SECOND ATTEMPT RESULTED IN THE BURR BECOMING STUCK, AND THE VIPER WIRE APPEARED SHEARED. IMAGING SUGGESTED THE DEVICE HAD BECOME EXTRAVASCULAR WITH SUSPECTED CIRCUMFLEX PERFORATION. OUTCOME ATTRIBUTED TO ADVERSE EVENT: DEATH". THE DATES OF EVENT AND PATIENT EXPIRATION WILL BE ESTIMATED AS (B)(6) 2026.

  Patient problems: Foreign Body In Patient

  MAUDE report 24401271 ↗
• InjuryFeb 2, 2026Entrapment of Device; Unintended System Motion; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A HEAVILY CALCIFIED, NON-TORTUOUS, 90% STENOSED OSTIUM CIRCUMFLEX ARTERY (CFX). THE VESSEL DIAMETER WAS 3.5 MM. THE PATIENT WAS TAKEN TO RECOVERY AND EXPERIENCED CHEST PAIN AND ST DEPRESSIONS. THE PHYSICIAN CONFIRMED THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP HAD FRACTURED AND THE 3 CM FRACTURED COMPONENT REMAINED IN VIVO. THE PATIENT WAS REFERRED TO SURGERY TO REMOVE THE FRACTURED COMPONENT AND RESOLVE THE PERFORATION. WHILE WAITING FOR SURGERY, THE PATIENT CODED. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND HEART PUMP WAS INSERTED. IT WAS APPROXIMATELY A 4-HOUR WAIT UNTIL THE PATIENT WAS TAKEN TO SURGERY. THE FRACTURED COMPONENT WAS SUCCESSFULLY REMOVED AND BYPASS WAS PERFORMED. THE PATIENT WAS STABLE. THE PHYSICIAN REVIEWED THE CASE AND BELIEVED THE WIRE WAS IN AN AREA WHERE TREATMENT WAS NOT PERFORMED [IN DISTAL 2ND OBTUSE MARGINAL ARTERY (OM)]. IT WAS SUSPECTED THE VIPERWIRE MAY HAVE MOVED OUTSIDE OF THE ARTERY AND WHEN THE VIPERWIRE AND GUIDE CATHETER WERE REMOVED, THE VIPERWIRE MAY HAVE BECOME STUCK AND FRACTURED WHICH CAUSED THE PERFORAT

  Patient problems: Angina; Cardiac Arrest; Foreign Body In Patient; Ischemia; Perforation of Vessels

  MAUDE report 24235814 ↗
• DeathJan 29, 2026

  THE PROCEDURE BEGAN AS A DIAGNOSTIC LEFT HEART CATH. DURING THE ATTEMPTED ORBITAL ATHERECTOMY OF THE CIRCUMFLEX, THE DIAMONDBACK CATHETER WAS UNABLE TO CROSS THE LESION. A SECOND ATTEMPT RESULTED IN THE BURR BECOMING STUCK, AND THE VIPER WIRE APPEARED SHEARED. IMAGING SUGGESTED THE DEVICE HAD BECOME EXTRAVASCULAR WITH SUSPECTED CIRCUMFLEX PERFORATION.

  Patient problems: Perforation

  MAUDE report 24208206 ↗
• InjuryDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ATHERECTOMY PROCEDURE IN A HIGHLY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA), THE VIPERWIRE CORONARY ADVANCE FLEXTIP GUIDEWIRE WAS POSITIONED WELL DISTAL TO THE CROWN, AND THE PROCEDURE WAS BEING PERFORMED SLOWLY WITH THE APPROPRIATE PAUSES. DUE TO THE SEVERE TORTUOSITY AND CALCIFICATION OF THE ARTERY, THE GUIDEWIRE FRACTURED, AND THE RADIOPAQUE TIP DETACHED AND MIGRATED DISTALLY IN THE ARTERY. THREE TREATMENTS WERE PERFORMED PRIOR TO GUIDEWIRE FRACTURE. IN ADDITION, PART OF THE CROWN OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) DETACHED AND MIGRATED INTO THE BLOODSTREAM. THE ENTIRE TIP OF THE OAD FRACTURED. THE PHYSICIAN REMOVED THE SYSTEM FROM THE PATIENT AND REPAIRED THE LESION WITH A STENT. AFTER THE LESION WAS TREATED, AN ATTEMPT WAS MADE TO CAPTURE THE WIRE TIP USING A SNARE, AND LATER BY APPLYING TORQUE WITH ANOTHER WIRE TO TRY TO COIL AND RETRIEVE IT INTO THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE RADIOPAQUE TIP OF THE VIPERWIRE WAS LEFT IN-VIVO TO AVOID ARTERIAL INJURY OR A POTENTIAL PERFORATION THAT COULD OCCUR IF OTHER RETRIEVAL METHODS WERE USED. THE PHYSICIAN LEFT THE RADIOOPAQUE TIP OF THE GUI

  Patient problems: Foreign Body In Patient

  MAUDE report 23789653 ↗
• InjuryDec 5, 2025Unintended System Motion; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Unintended System Motion; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN LEFT ANTERIOR DESCENDING ARTERY (LAD) A NON-ABBOTT GUIDE WIRE AND MICROCATHETER WERE USED TO GAIN ACCESS THEN EXCHANGED FOR A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP. WHILE ADVANCING THE DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) TO THE LESION ON GLIDEASSIST, THE VIPERWIRE CAME BACK DUE TO THE TORTUOSITY. THERE WAS SIGNIFICANT WIRE BIAS. THERE WAS DIFFICULTY WIRING OR DELIVERING DEVICES. THE OAD AND VIPERWIRE DID NOT MAKE CONTACT. THE VIPERWIRE WAS ACCIDENTALLY PULLED THROUGH THE BACK OF THE OAD. THE PHYSICIAN PROCEEDED TO REMOVE THE VIPERWIRE AND FELT RESISTANCE AT THE OAD DRIVE SHAFT AND THEN STUCK TO THE OAD AND REMOVED IT WHICH RESULTED IN THE DISTAL RADIOPAQUE SPRING TIP FRACTURING. THE FRACTURED COMPONENT WAS SNARED SUCCESSFULLY. THE VIPERWIRE WAS REPLACED TO COMPLETE THE PROCEDURE WITH THE SAME OAD. THERE WERE NO ISSUES REPORTED ON THE OAD GUIDE WIRE BRAKE OR CONTROL KNOB. THERE WAS NO DRIVESHAFT DAMAGE. THE PATIENT WAS STABLE. THE PHYSICIAN HAS NO CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728758 ↗
• InjuryNov 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A NON-ABBOTT WIRE WAS USED TO CROSS THE LESION AND THEN A MICROCATHETER WAS USED TO SWAP IT OUT FOR THE VIPERWIRE ADVANCE CORONARY GUIDEWIRE AFTER CROSSING THE LESION. A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED UNTIL THE CROWN WAS ADVANCED JUST SHORT OF THE LESION. FIVE TO SIX TREATMENTS WERE PERFORMED AND IT WAS UNABLE TO CROSS THE LESION. OAD WAS REMOVED AND A NON-COMPLIANT BALLOON WAS USED THAT DID NOT CROSS THE LESION EITHER. OAD WAS REINTRODUCED AGAIN AND IT WAS FINALLY ABLE TO CROSS ON THE THIRD AND FOURTH ATTEMPT OF LOW SPEED TREATMENTS. THREE MORE TREATMENTS WERE PERFORMED ONCE THE LESION WAS CROSSED TO OPEN THE VESSEL UP. THERE WERE NO OTHER ISSUES DURING THE ATHERECTOMY PORTION OF THE PROCEDURE, HOWEVER, ONCE THE OAD WAS REMOVED SAFELY, THE PHYSICIAN TRIED TO REMOVE THE VIPERWIRE CORONARY VIPERWIRE AND IT WAS LODGED DISTALLY IN THE VESSEL. WHILE TRYING TO REMOVE THE WIRE IT BROKE OFF, AND ABOUT 12MM OF DISTAL PORTION OF THE WIRE REMAINED IN THE VESSEL. ATTEMPTS WERE MADE TO SNARE IT OUT, BUT WAS LEFT IN-VIVO AS IT WAS NOT WORTH THE RISK IN THE PHYSICIAN'S OPINION. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23649616 ↗
• InjuryNov 19, 2025Material Separation; Device Damaged by Another Device; Difficult to Advance; Material Separation; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT A 95% STENOSED HEAVILY CALCIFIED LESION IN LEFT ANTERIOR DESCENDING (LAD) ARTERY, A NON-ABBOTT WIRE WAS ADVANCED DOWN THE LAD. IT WAS EXCHANGED WITH AN EXCHANGER CATHETER, THEN A FLOPPY WAS ADVANCED AND THE EXCHANGE CATHETER WAS REMOVED. IT WAS NOTED THAT THE VIPERWIRE GUIDEWIRE WAS EXCHANGED AND INITIALLY THERE WAS DIFFICULTY WITH THE EXCHANGE CATHETER CROSSING THE LESION. A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED FROM PROXIMAL LAD TO MID LAD, HOWEVER, THE VIPERWIRE CORONARY GUIDEWIRE WAS NOT ABLE TO CROSS THE DISTAL END OF THE LESION. THE OAD WAS REMOVED. THE PHYSICIAN REPOSITIONED THE VIPERWIRE FURTHER DOWN THE LAD, AND THEN ADVANCED IN WITH THE OAD. ONE HIGH SPEED TREATMENT WAS PERFORMED AND WAS ABLE TO CROSS THE DISTAL EDGE. DURING HIGH SPEED TREATMENTS, THE OAD PUSHED THE GUIDE BACK INTO THE AORTA WHICH PULLED VIPERWIRE GUIDEWIRE BACK AND GOT TOO CLOSE TO THE CROWN. THE OAD MADE CONTACT WITH THE SPRING TIP. THE RADIO OPAQUE SEGMENT OF THE WIRE GOT SHEARED OFF. FOUR LOW SPEED TREATMENTS AND TWO HIGH SPEED TREATMENTS WERE PERFORMED BEFORE THE GUIDEWIRE FRACTURE. THE ENTIRE RADIOPAQUE PORTION OF THE GUIDEW

  Patient problems: Foreign Body In Patient

  MAUDE report 23597864 ↗
• InjuryNov 10, 2025Material Separation; Material Separation

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SEVERELY CALCIFIED, TORTUOUS, 90% STENOSED LEFT CIRCUMFLEX ARTERY (LCX). EIGHT TO TEN TREATMENTS WERE PERFORMED. THE OAD CROWN WAS BROUGHT BACK TO THE GUIDE CATHETER AND PARKED TO MOVE THE VIPERWIRE GUIDE WIRE INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THIS, THE VIPERWIRE SPRING TIP FRACTURED. IT WAS INDICATED THE LESION WAS CALCIFIED AND TORTUOUS. THERE WAS NO INDICATION AS TO WHAT LED TO THE FRACTURE. THE FRACTURED COMPONENT WAS ABLE TO BE RETRIEVED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513142 ↗
• InjuryOct 24, 2025Unintended System Motion; Difficult to Remove; Material Separation; Unintended System Motion; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED THROUGH FEMORAL ACCESS IN AN ATTEMPT TO TREAT HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESIONS IN LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT MAIN ARTERY (LM). THE ESTIMATED VESSEL DIAGRAM BASED ON ANGIOGRAM WAS 2.5 MM-3.0 MM; NO INTRACORONARY IMAGING WAS DONE PRIOR TO ORBITAL ATHERECTOMY. A HEART PUMP WAS INSERTED PRIOR TO THE PROCEDURE. AN EBU 9 (EXTRA BACK-UP) 3.75 7FR GUIDE CATHETER WAS IN USE. THE LESION WAS PRIMARY WIRED WITH A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP. THE OAD WAS TESTED EX VIVO PRIOR TO ADVANCING IN VIVO. THE OAD WAS ADVANCED TO THE PROXIMAL END OF THE LESION IN LAD FOR THE FIRST TREATMENT. ONE PROXIMAL-TO DISTAL LOW-SPEED TREATMENT AND ONE DISTAL-TO-PROXIMAL LOW-SPEED TREATMENT WERE PERFORMED. AT THIS TIME, THE PHYSICIAN ELECTED TO USE GLIDEASSIST TO RETRACT THE OAD, HOWEVER, THE OAD WAS NOT MOVING AND IT FELT AS IF THE OAD AND THE VIPERWIRE WERE FUSED TOGETHER. IT WAS FURTHER EXPLAINED AS THE OAD APPEARING TO HAVE LOCKED OUT WHEN IN THE CALCIUM. THERE WAS A FLASHING LIGHT ON THE OAD OBSERVED INDICATING A STALL. AFTER WAITING FOR 5

  Patient problems: Foreign Body In Patient

  MAUDE report 23381096 ↗
• InjuryOct 20, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF DIFFUSE, LONG, 360-DEGREE/HEAVILY CALCIFIED, NON-TORTUOUS, 90% STENOSED LESION IN MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-ABBOTT GUIDE WIRE WAS EXCHANGED FOR A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. THERE WAS NO WIRE BIAS. TWO LOW-SPEED TREATMENTS WERE PERFORMED. DURING THE THIRD TREATMENT WHICH WAS AT LOW SPEED, THERE WAS NO SUPPORT AND AN UNSPECIFIED GUIDE KEPT ON COMING BACK A LITTLE BIT. WHEN THE GUIDE STARTED PULLING BACK IT PULLED THE VIPERWIRE WITH IT AND THAT¿S WHEN THE OAD CROWN CROSSED THE LESION, JUMPED FORWARD AND SHEARED OFF THE VIPERWIRE RADIOPAQUE SPRING TIP. THE FRAGMENT REMAINED IN DISTAL LAD. AS THE PHYSICIAN BELIEVED SNARING THE FRAGMENT WOULD HAVE BEEN MORE HARMFUL, A STENT WAS USED TO PIN THE FRAGMENT ON THE ARTERY WALL IN DISTAL LAD AND A SECOND STENT PLACEMENT WAS PERFORMED IN MID LAD TO FINISH TREATING IT. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT WAS STABLE AND DISCHARGED AS PLANNED. THE PHYSICIAN DOES NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCO

  Patient problems: Foreign Body In Patient

  MAUDE report 23336889 ↗
• InjuryOct 17, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESION IN MID CIRCUMFLEX ARTERY (CFX) THROUGH FEMORAL ARTERY ACCESS USING 6 FR GUIDE CATHETER WHICH WAS INSERTED TO THE LEFT MAIN ARTERY (LM) AND CANNULATED. ANTICOAGULATION WAS STARTED. THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WAS ADVANCED WITHOUT RESISTANCE THROUGH THE LESION IN THE MID CFX AND THE RADIOPAQUE TIP WAS POSITIONED IN MID OBTUSE MARGINAL ARTERY (OM1). THE VESSEL WAS PRIMARILY WIRED WITH VIPERWIRE. THERE WAS MODERATE WIRE BIAS. THE OAD WAS PREPARED AND ADVANCED ON GLIDEASSIST INTO THE VESSEL. THE METHOD OF TREATMENT DUE TO CALCIFICATION AND TORTUOSITY WAS RETROGRADE. THE CROWN WAS ADVANCED PAST THE LESION AND POSITIONED DISTAL TO THE LESION. THE FIRST TREATMENT WHICH WAS ON LOW SETTING WAS SUCCESSFUL WITH NO ISSUES AND ONE-TO-ONE MOTION WAS IDENTIFIED. TO PERFORM A SECOND TREATMENT, GLIDEASSIST WAS AGAIN USED TO CROSS THE LESION TO REMOVE COMPRESSION BUILD UP AND ENSURE SMOOTH TRANSITION ACROSS THE LESION. MOTION WAS IDENTIFIED AS ONE-TO-ONE WHILE USING GLIDEASSIST FOR THE SECOND TREATMENT. THE VIPERWIRE WAS NOTED ON ANGIOGRAM TO BE MIDWAY DOW

  Patient problems: Angina; Nausea

  MAUDE report 23327752 ↗
• InjuryOct 15, 2025Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS A HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI) ON A HIGHLY CALCIFIED OSTIAL CIRCUMFLEX LESION. IT WAS NOTED THAT THE PROCEDURE TO TREAT A SOFT PLAQUE LESION IN THE LAD THE PREVIOUS DAY ((B)(6) 2025) WAS ABORTED. AN UNKNOWN STENT WAS PLACED DURING THE PROCEDURE, BUT THE STENT WAS NOT WITHIN THE RANGE TO BE CONSIDERED A BIFURCATION LESION. AFTER STENTING THE LAD, THE PATIENT HAD A COUGHING FIT AND PRESENTED WITH SIGNIFICANT SYMPTOMS OF ANXIETY, ASKING TO BE ABLE TO STAND UP DUE TO ANXIETY. THE PROCEDURE WAS ABORTED. ON (B)(6) 2025 DURING THE PROCEDURE TO TREAT OSTIAL CIRCUMFLEX LESION, THE PATIENT HAD SYMPTOMS OF ANGINA AND WAS PUT UNDER ANESTHESIA DUE TO INABILITY TO CONTROL ANXIOUSNESS DURING PREVIOUS DAY¿S CASE. THE RIGHT CORONARY SYSTEM WAS OKAY. A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TREAT THE OSTIAL CIRCUMFLEX LESION. A NON-ABBOTT WORKHORSE WIRE AND A NON-ABBOTT MICRO CATHETER WAS USED TO WIRE THE CIRCUMFLEX ARTERY. THE WIRE WAS EXCHANGED TO A VIPERWIRE CORONARY FLEXTIP GUIDEWIRE AND THE NON-ABBOTT GUIDEWIRE AND CATHETER WERE REMOVED. THE RADIOPAQUE MARKER OF THE VIPERWIRE GUIDEWIRE WAS PLACED DOWN THE CIRCU

  Patient problems: Foreign Body In Patient

  MAUDE report 23294617 ↗
• InjurySep 8, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT THE RIGHT CORONARY ARTERY (RCA). DURING TREATMENT, IT WAS INDICATED THE NECESSARY SPACE BETWEEN THE OAD DRIVESHAFT AND VIPERWIRE SPRING TIP WAS NOT MAINTAINED. AFTER FIVE LOW SPEED TREATMENTS, THERE WAS FRICTION BETWEEN THE OAD AND VIPERWIRE GUIDE WIRE, WHICH LED TO SUBSEQUENT DETACHMENT OF THE VIPERWIRE SPRING TIP. VESSEL PREDILATION AND A STENT WERE USED TO SECURE THE FRACTURED COMPONENT. THE FRACTURED COMPONENT REMAINED IN-VIVO. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. IT WAS INDICATED THERE WAS NO WIRE BIAS OBSERVED DURING THE PROCEDURE AND THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22996248 ↗
• InjuryAug 14, 2025Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES VIPER WIRE (FROM THE ORBITAL ATHERECTOMY SYSTEM- DIAMONDBACK DEVICE) FRACTURED AND SHEARED OFF INTO THE VESSEL AND REMAINED IN OBTUSE MARGINAL ARTERY. THERE IS DISTAL TIP DETACHMENT OF VIPERWIRE, THERE WAS NO OPTION OF RETRIEVING IT DUE TO SEVERE STENOSIS IN PROXIMAL VESSEL AND DISTAL LOCATION OF THE WIRE TIP. WE DECIDED TO TREAT BY PLACEMENT OF DES [DRUG-ELUTING STENT] AND TRAPPING THE WIRE BEYOND IT. ADDITIONAL INFORMATION RECEIVED ON 07/31/2025: THE TARGET LESION WAS SEVERELY CALCIFIED DISTAL OBTUSE MARGINAL ARTERY (OM) WHICH WAS ACCESSED THROUGH RADIAL ARTERY. FOUR ATHERECTOMY TREATMENTS WERE PERFORMED PRIOR TO THE VIPERWIRE FRACTURE. THERE IS NO INDICATION AS TO HOW THE FRACTURE OCCURRED BUT THE MONITOR TECHNICIAN (RT) BELIEVES THE PHYSICIAN HAD THE OAD CROWN TOO CLOSE TO THE VIPERWIRE SPRING TIP. THE OAD CROWN DID NOT JUMP PRIOR TO THE FRACTURE. THERE WAS NO WIRE BIAS. THE FRAGMENT LEFT IN THE PATIENT WAS APPROXIMATELY 30MM LONG (RADIOPAQUE TIP). THE PHYSICIAN STENTED THE FRAGMENT IN PLACE DUE TO BEING TOO DISTAL AND TOO DIFFICULT TO TRY TO REACH. THE VESSEL WAS PRIMARILY WIRED WITH NON-ABBOTT GUIDE WIRE WHICH WAS EXCHANGED F

  Patient problems: Foreign Body In Patient

  MAUDE report 22811333 ↗
• InjuryAug 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WAS USED WITH DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) FOR TREATMENT OF HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN LEFT ANTERIOR DESCENDING ARTERY (LAD). AN UNSPECIFIED WIRE WAS EXCHANGED FOR THE VIPERWIRE GUIDEWIRE. THREE LOW SPEED- TREATMENTS WERE PERFORMED. A FOURTH LOW-SPEED TREATMENT WAS GOING TO BE PERFORMED WHEN IT WAS OBSERVED THAT THE OAD WAS NO LONGER ON THE VIPERWIRE GUIDEWIRE AS IT WAS GOING DOWN THE DIAGONAL ARTERY INSTEAD OF LAD. THE OAD CROWN AND VIPERWIRE WERE RETRACTED BUT IT WAS NOTICED THE VIPERWIRE SPRING TIP WAS DETACHED. THERE WAS NO INDICATION AS TO HOW THE FRACTURE OCCURRED. THE OAD CROWN DID NOT JUMP PRIOR TO THE FRACTURE AND THE OAD DID NOT HIT THE SPRING TIP. THE OAD AND THE SPRING TIP WERE 30 MILLIMETERS APART. THERE WAS NO WIRE BIAS. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. THE WHOLE RADIOPAQUE TIP WAS ABANDONED IN THE DIAGONAL ARTERY. AN ATTEMPT WAS MADE TO PUT ANOTHER INTERVENTION WIRE DOWN THE LAD ALONGSIDE THE VIPERWIRE GUIDEWIRE TO TWIST THEM TOGETHER TO TRY TO PULL OUT THE BROKEN FRAGMENT. A SNARE COULD NOT BE AD

  Patient problems: Foreign Body In Patient

  MAUDE report 22748772 ↗
• InjuryJul 1, 2025Material Separation; Device Damaged by Another Device; Difficult to Advance; Material Separation; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WERE USED FOR TREATMENT OF MILDLY TORTUOUS LESION IN CIRCUMFLEX ARTERY (CFX) OBTUSE MARGINAL (OM) FROM THE FIRST OM THROUGH RIGHT FEMORAL ARTERY ACCESS WITH 6FR SHEATH. THE VESSEL WAS PRIMARY WIRED WITH UNSPECIFIED GUIDE WIRE WHICH WAS EXCHANGED FOR THE VIPERWIRE. THERE WAS SOME WIRE BIAS AND GETTING THE WIRE WAS DIFFICULT INITIALLY. SEVERAL UNSPECIFIED SUPPORT CATHETERS WERE NEEDED TO TRAVERSE THE ANATOMY. AT THE END OF THE PROCEDURE FOLLOWING THREE LOW-SPEED TREATMENTS AND ONE HIGH-SPEED TREATMENT THE DISTAL RADIOPAQUE PORTION OF THE VIPERWIRE TIP WAS SHEARED OFF. THE OAD CROWN JUMPED DURING THE THIRD TREATMENT, BUT DID NOT MAKE CONTACT WITH THE VIPERWIRE SPRING TIP. THE OPERATOR SUSPECTED THE INTERACTION WITH THE CATHETER WAS THE CAUSE OF THE VIPERWIRE FRACTURE. THE TIP OF THE VIPERWIRE WAS NOT RETRIEVED, SINCE THIS OCCURRED TOWARD THE END OF THE PROCEDURE. THE TIP WAS STENTED TO THE WALL WITHOUT ANY CONCERN FOR LONG-TERM COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22373060 ↗
• InjuryJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WAS USED WITH THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) FOR TREATMENT OF LESION WITH 75% STENOSIS, HEAVY CALCIFICATION, AND MODERATE TORTUOSITY IN LEFT CIRCUMFLEX ARTERY (LCX). THE REFERENCE VESSEL DIAMETER WAS 3 MM. THE LESION WAS OBSERVED WITH INTRAVASCULAR ULTRASOUND (IVUS), AND OAD WAS SELECTED FOR TREATMENT. THE VESSEL WAS PRIMARY WIRED WITH AN UNSPECIFIED GUIDE WIRE WHICH WAS EXCHANGED FOR A VIPERWIRE. THERE WAS MILD WIRE BIAS. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. THE OAD WAS DELIVERED TO THE LESION ON GLIDEASSIST MODE. TWO LOW-SPEED TREATMENTS WERE PERFORMED AND IVUS WAS USED TO OBSERVE THE LESION. THE PHYSICIAN DETERMINED ADDITIONAL TREATMENT WAS REQUIRED; THEREFORE, DISTAL-TO-PROXIMAL, HIGH-SPEED TREATMENT WAS PERFORMED AFTER THE OAD WAS ADVANCED ON GLIDEASSIST MODE. HOWEVER, UNUSUAL NOISE WAS OBSERVED AND THE OAD CROWN STOPPED ROTATING WITH THE LED LIGHTS OF THE OAD ILLUMINATED. IT APPEARED THE CROWN JUMPED, BUT IT WAS NOT CONFIRMED IF THE CROWN MADE CONTACT WITH THE SPRING TIP. THE OPERATOR WAS NOT ADVANCING AGAINST RESISTANCE. ADDITIONALLY, THE 2.5 CM VIPERWIRE SPRING TIP

  Patient problems: Foreign Body In Patient

  MAUDE report 22372993 ↗