ViperWire Advance FlexTip VPR-GW-FLEX14Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 10852528005718), received between Aug 27, 2019 and Aug 13, 2026 — classified as 68 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Separation” (69 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 76 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  Patient problems: Foreign Body In Patient

  MAUDE report 50244494 ↗
• InjuryMar 12, 2026Material Separation

  IT WAS REPORTED A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE OAD CONTACTED THE VIPERWIRE SPRING TIP LEADING TO A FRACTURE. THE FRACTURED COMPONENT WAS RETRIEVED WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. IT WAS INDICATED THE OAD CONTACTING THE VIPERWIRE SPRING TIP WAS DUE TO USE ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582804 ↗
• InjuryFeb 5, 2026Material Separation

  IT WAS REPORTED THAT ABBOTT COMMAND WIRE WAS DURING PROCEDURE PAST SUPERFICIAL FEMORAL ARTERY (SFA) LESION AND ORBITAL ATHERECTOMY WAS PERFORMED WITHOUT ISSUES. THREE TREATMENTS ON LOW, MEDIUM AND HIGH SPEEDS WERE PERFORMED. IT WAS BIDIRECTION TREATMENT. ARMADA18 BALLOON WAS LOADED ONTO THE VIPERWIRE PERIPHERAL GUIDEWIRE FOR POST DILATION AND UPON ARMADA BALLOON BEING DEFLATED, IT WAS NOTED THE WIRE WAS MISSING AND TRAVELED DOWN THE LEG A SMALL WAY. THE BROKEN VIPERWIRE GUIDEWIRE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT¿S LEG BY TRAPPING IT WITH A TREK CORONARY BALLOON AND REMOVING THE WHOLE WIRE, BALLOON, AND SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS. IT WAS NOTED THAT THERE WAS NO WIRE BIAS AND THERE IS NO INDICATION ON HOW THE FRACTURE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272640 ↗
• MalfunctionJan 29, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT A VIPERWIRE PERIPHERAL FLEXTIP GUIDEWIRE WAS USED WITH A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) TO TREAT CALCIFICATION DIFFUSED DISEASE THROUGHOUT THE POSTERIOR TIBIAL (PT) ARTERY TO THE DORSALIS PEDIS (DP). EIGHT TREATMENTS WERE PERFORMED IN THE PT ON LOW SPEED, THE VIPERWIRE GUIDEWIRE CROSSED THE ANKLE AND THE OAD DID NOT CROSS THE ANKLE BY PHYSICIAN'S CHOICE. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE OAD. THE PHYSICIAN PURPOSELY STAYED AWAY FROM THAT AREA DUE TO ANATOMY AND TO KEEP PLENTY OF SPACE AWAY FROM WIRE TIP. THE VESSEL WAS BALLOONED AND THERE WAS DIFFICULTY DURING REMOVAL OF THE GUIDEWIRE FROM THE VESSEL AFTER TREATMENT. THE GUIDEWIRE WAS FORCEFULLY REMOVED AND DID NOT FRACTURE, HOWEVER, THE SPRING TIP WAS FRAYED. IT WAS NOTED THAT OAD AND GUIDEWIRE DID NOT MAKE CONTACT DURING THE PROCEDURE. THE PHYSICIAN SUSPECTED THE ISSUE WAS DUE TO PATIENT ANATOMY. IT WAS NOTED THAT THE ISSUE WITH THE GUIDEWIRE HAPPENED IN THE FOOT WHERE THERE WAS NO PRIOR TREATMENT WITH OAD OR ANY BALLOONING. THE PATIENT WAS STABLE. INITIAL ANALYSIS OF THE RETURNED VIPERWIRE PERIPHERAL GUIDEWIRE INDICATED THAT THE SPRING TIP STRAIN RELIEF WAS UNRAVELED BUT NOT DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24211821 ↗
• InjuryDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT POST ATHERECTOMY PROCEDURE, DURING REMOVAL, THE VIPERWIRE PERIPHERAL GUIDEWIRE FRACTURED AND THE TIP OF THE GUIDEWIRE REMAINED IN-VIVO. A SNARE WAS USED TO RETRIEVE THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871838 ↗
• InjuryDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER REMOVING THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP REMAINED IN THE PATIENT. SNARE WAS USED TO REMOVE THE TIP OF THE VIPERWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23867125 ↗
• InjuryDec 8, 2025Entrapment of Device; Unintended System Motion; Material Separation; Entrapment of Device; Unintended System Motion; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT LESION IN CALCIFIED, HIGHLY TORTUOUS, 85% STENOSED DISTAL DORSALIS PEDIS ARTERY (DP), THE 1.25 MICRO DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SHUT OFF DURING FIRST RUN. THE VESSEL DIAMETER WAS 2.00MM. THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WAS EXCHANGED FROM A NON-ABBOTT WIRE. DURING REMOVAL, IT WAS NOTED THAT THE OAD BECAME ENTANGLED IN THE DISSECTION FLAP. THERE WAS NO DISSECTION BEFORE THE PROCEDURE. THE DISSECTION WAS NOT SEEN ANGIOGRAPHICALLY BUT THE PHYSICIAN THOUGHT IT WAS A SMALL FLAP THAT THE CROWN GOT STUCK ON. THE OAD AND THE VIPERWIRE COULD NOT BE REMOVED DUE TO THE VIPERWIRE BEING FRACTURED AND STUCK IN THE VESSEL. A CUT DOWN PROCEDURE WAS PERFORMED FOR REMOVAL, AND THE PHYSICIAN WAS ABLE TO REMOVE THE CROWN, BUT THE ENTIRE RADIOPAQUE SECTION OF THE VIPERWIRE TIP WAS LEFT IN THE LEG AS THERE WAS NO LONGER ACCESS TO THE VESSEL. WIRE ACCESS WAS LOST DUE TO THE VIPERWIRE BEING STUCK IN THE VESSEL DISTAL TO THE CROWN THAT WAS STUCK IN THE VESSEL WALL. THE VIPERWIRE RADIOPAQUE TIP WAS LEFT IN THE FOOT AND THE CUT DOWN TO REMOVE THE CROWN WAS SUTURED CLOSED. THE DISSECTION WAS N

  Patient problems: Foreign Body In Patient

  MAUDE report 23750456 ↗
• InjuryDec 5, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A 1.25 SOLID DIAMONDBACK 360 PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, NON-TORTUOUS, CHRONIC TOTAL OCCLUSION (CTO) LESION IN RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH LEFT FEMORAL ARTERY UP-AND-OVER APPROACH. A 7FR SHEATH WAS IN USE. AN ABBOTT COMMAND GUIDE WIRE WAS INITIALLY ADVANCED TO THE LESION AS FAR AS IT CAN GO AND EXCHANGED FOR A VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP. THE VIPERWIRE GUIDEWIRE WAS THEN ADVANCED HALFWAY THROUGH THE SFA. THERE WAS NO WIRE BIAS. INITIAL TREATMENT WAS STARTED. THE PHYSICIAN WAS AWARE THEY WERE TOO CLOSE TO THE TIP OF THE VIPERWIRE GUIDEWIRE BUT CONTINUED ADVANCING AS CLOSE AS THEY COULD AS THIS WAS A LAST EFFORT TO PREVENT SURGERY. THIS RESULTED IN THE OAD CROWN COMING IN CONTACT WITH THE VIPERWIRE TIP CAUSING GUIDEWIRE FRACTURE. THE VIPERWIRE RADIOPAQUE TIP REMAINED IN THE RIGHT SFA WITHOUT FURTHER MEDICAL INTERVENTION SINCE THE PHYSICIAN BELIEVED NO DEVICE COULD GET THROUGH THE OCCLUSION. THE OAD AND THE VIPERWIRE WERE REMOVED. THE PROCEDURE WAS ABORTED. THE PATIENT WAS SCHEDULED FOR SURGICAL FEMORAL BYPASS. THE DATE OF THE PROCEDURE WAS UNKNOW

  Patient problems: Foreign Body In Patient

  MAUDE report 23730325 ↗
• InjuryNov 19, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A 1.25 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND A VIPERWIRE PERIPHERAL GUIDEWIRE WERE USED TO TREAT THE PERONEAL ARTERY. THE VESSEL WAS PRIMARILY WIRED WITH THE VIPERWIRE GUIDEWIRE. APPROXIMATELY NINE TREATMENTS WERE PERFORMED ON LOW, MEDIUM, AND HIGH-SPEED. THE OAD MADE CONTACT WITH THE SPRING TIP, RESULTING IN A GUIDE WIRE FRACTURE. THE ENTIRE RADIOPAQUE TIP REMAINS IN VIVO. THERE WAS NO WIRE BIAS. AN ATTEMPT WAS MADE TO BALLOON THE FRAGMENT TO THE WALL BUT IMAGING DID NOT SHOW ANY MOVEMENT OF THE FRAGMENT. IN ADDITION, PERSISTENT SLOW FLOW WAS OBSERVED. NITROGLYCERIN WAS ADMINISTERED. THE PATIENT WAS STABLE. THE PHYSICIAN DID NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES. ADDITIONAL INFORMATION WAS RECEIVED AND IN THE OPINION OF THE PHYSICIAN, THE VIPERWIRE GUIDEWIRE WAS THE CAUSE OF THE SLOW FLOW AND FLOW WAS RESTORED ON ITS OWN. THE PATIENT'S WOUNDS WERE HEALING.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 23597757 ↗
• InjuryNov 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 99% STENOSED, HEAVILY CALCIFIED, MILDLY TORTUOUS POPLITEAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 7FR SHEATH RIGHT GROIN ACCESS, A 1.5 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH VIPERWIRE GUIDEWIRE. IT WAS NOTED THAT THERE WAS NO WIRE BIAS AND THE VESSEL WAS NOT PRIMARILY WIRED WITH VIPERWIRE GUIDEWIRE, IT WAS EXCHANGED. DURING REMOVAL OF THE CATHETER, THE GUIDEWIRE TIP BROKE OFF AS IT WAS STUCK ON CALCIUM. THE RADIO OPAQUE TIP OF THE WIRE ABOUT 3 CM IN LENGTH WAS SNARED. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485699 ↗
• InjurySep 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PERIPHERAL INTERVENTION OF THE LEFT LEG VIA RIGHT FEMORAL ARTERY & LEFT POSTERIOR TIBIAL (PT) PEDAL ACCESS, A VIPERWIRE PERIPHERAL GUIDEWIRE WAS ADVANCED DOWN INTO THE DISTAL PERONEAL ARTERY. THE 1.25 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PLACED OVER THE VIPERWIRE GUIDEWIRE TO TREAT THE TIBIOPERONEAL (TP) TRUNK AND DOWN TO ABOUT THE MID-PERONEAL. AT SOME POINT BETWEEN CHECKING THE VIPERWIRE GUIDEWIRE TIP PLACEMENT AND THEN ACTUALLY STARTING THE TREATMENT, THE GUIDEWIRE WAS PULLED BACK AND THEN ADVANCED DEEP INTO A COLLATERAL. DURING FIRST TREATMENT, A SLACK IN THE VIPERWIRE GUIDEWIRE WAS NOTICED ON THE FLOUROSCOPY MONITOR. THE GUIDEWIRE FRACTURED AND THE OAD AUTOMATICALLY SHUT OFF. THE OAD WAS REMOVED, TWO GUIDEWIRE FRAGMENTS LEFT IN-VIVO. THE MAJORITY OF THE TIP OF THE VIPERWIRE GUIDEWIRE SPRING TIP WAS LODGED DEEP INTO A COLLATERAL OFF OF THE PERONEAL. A SMALL PIECE OF WIRE FRAGMENT WAS AT THE DISTAL TO THE TAKEOFF OF THE PERONEAL. MULTIPLE SNARES WERE USED TO TRY AND REMOVE THE FRAGMENTS BUT WERE UNSUCCESSFUL. AT THIS POINT IT WAS NOTICED THAT THE SMALL PROXIMAL FRAGMENT PIECE WAS MOSTLY OCCLUSIVE AND THERE WAS NO FLOW IN E

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 23028417 ↗
• InjuryJun 23, 2025Material Separation; Material Separation

  IT WAS REPORTED A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A HEAVILY CALCIFIED LESION IN RIGHT PROXIMAL ANTERIOR TIBIAL ARTERY (AT). AFTER TWO LOW SPEED TREATMENTS AND ONE MEDIUM SPEED TREATMENT, THE VIPERWIRE PERIPHERAL GUIDE WIRE FRACTURED IN HALF AND WAS SUCCESSFULLY SNARED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PROCEDURE WAS DELAYED BY 30-40 MINS. THIS WAS NOT CONSIDERED CLINICALLY SIGNIFICANT DELAY. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE, 2.5X240 JADE BALLOON, AND NC TREK BALLOON TO OPEN UP AT. IT WAS UNKNOWN HOW THE GUIDE WIRE FRACTURE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309870 ↗
• InjuryApr 18, 2025Off-Label Use; Material Separation; Off-Label Use; Material Separation

  DURING PROCEDURE TO TREAT 90% STENOSED HEAVILY CALCIFIED ANTERIOR TIBIAL ARTERY, TWO TREATMENTS WERE PERFORMED USING A NON-ABBOTT ATHERECTOMY DEVICE. THE VESSEL WAS PRIMARILY WIRED WITH A NON-ABBOTT GUIDEWIRE AND WAS THEN EXCHANGED FOR A VIPERWIRE ADVANCE PERIPHERAL GUIDEWIRE. DURING PROCEDURE, THE TIP OF THE VIPERWIRE PERIPHERAL GUIDEWIRE BROKE OFF IN THE PATIENT AND FULL SOFT TIP OF THE VIPER WIRE FLEX TIP WAS LEFT IN-VIVO. THIS OCCURRED DURING AN OUTPATIENT VISIT AND THE PATIENT WAS SENT HOME. ON (B)(6) 2025, THE PATIENT WAS BROUGHT BACK AND THE WIRE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING SNARE. THE PATIENT WAS IN STABLE CONDITION AND THE PHYSICIAN DOES NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PHYSICIAN WAS AWARE THE GUIDEWIRE WAS BEING USED AGAINST THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 21865866 ↗
• MalfunctionApr 15, 2025Unintended System Motion; Deformation Due to Compressive Stress; Difficult to Advance; Unintended System Motion; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE TARGET LESION WAS IN SUPERFICIAL FEMORAL ARTERY (SFA) WHICH WAS MILDLY CALCIFIED AND NON-TORTUOUS. DURING ADVANCEMENT OF THE 5.0MM X 40MM JADE .014" OTW 150CM OVER THE .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP THROUGH A 6F NON-ABBOTT SHEATH, THE BALLOON WAS STICKING TO THE VIPERWIRE AND PULLED IT OUT OF POSITION. ANTEGRADE FEMORAL ARTERY APPROACH WAS USED WHICH WAS NOTED TO HAVE A SHARP BEND. A NEW VIPERWIRE WAS USED, AND THE SAME JADE BALLOON WAS THEN ATTEMPTED TO BE ADVANCED WITH THE SAME STICKING ENCOUNTERED. THE VIPERWIRE, JADE BALLOON AND SHEATH WERE ALL REMOVED FROM THE PATIENT WHERE IT WAS IDENTIFIED BOTH VIPERWIRES AND THE SHEATH WERE KINKED. THE VIPERWIRES WERE KINKED ONE THIRD DOWN THE WIRE AND THE SHEATH WAS KINKED ABOUT 30CM PROXIMAL. A NEW SHEATH, JADE BALLOON AND ABBOTT COMMAND WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR ADVERSE PATIENT EFFECTS REPORTED. THE VIPERWIRES AND JADE BALLOON WERE PREPARED ACCORDING TO INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS AND THE VIPERWIRES WERE WETTED THROUGHOUT USE. IT WAS BELIEVED THE 6F SHEATH BECAME KINKED DUE THE SHARP BEND IN THE ACCESS SITE AND CAUSED THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21842203 ↗
• MalfunctionApr 15, 2025Unintended System Motion; Deformation Due to Compressive Stress; Difficult to Advance; Unintended System Motion; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE TARGET LESION WAS IN SUPERFICIAL FEMORAL ARTERY (SFA) WHICH WAS MILDLY CALCIFIED AND NON-TORTUOUS. DURING ADVANCEMENT OF THE 5.0MM X 40MM JADE .014" OTW 150CM OVER THE .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP THROUGH A 6F NON-ABBOTT SHEATH, THE BALLOON WAS STICKING TO THE VIPERWIRE AND PULLED IT OUT OF POSITION. ANTEGRADE FEMORAL ARTERY APPROACH WAS USED WHICH WAS NOTED TO HAVE A SHARP BEND. A NEW VIPERWIRE WAS USED, AND THE SAME JADE BALLOON WAS THEN ATTEMPTED TO BE ADVANCED WITH THE SAME STICKING ENCOUNTERED. THE VIPERWIRE, JADE BALLOON AND SHEATH WERE ALL REMOVED FROM THE PATIENT WHERE IT WAS IDENTIFIED BOTH VIPERWIRES AND THE SHEATH WERE KINKED. THE VIPERWIRES WERE KINKED ONE THIRD DOWN THE WIRE AND THE SHEATH WAS KINKED ABOUT 30CM PROXIMAL. A NEW SHEATH, JADE BALLOON AND ABBOTT COMMAND WIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO DELAY OR ADVERSE PATIENT EFFECTS REPORTED. THE VIPERWIRES AND JADE BALLOON WERE PREPARED ACCORDING TO INSTRUCTIONS FOR USE (IFU) INSTRUCTIONS AND THE VIPERWIRES WERE WETTED THROUGHOUT USE. IT WAS BELIEVED THE 6F SHEATH BECAME KINKED DUE THE SHARP BEND IN THE ACCESS SITE AND CAUSED THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841941 ↗
• InjuryMar 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A 2.0 SOLID DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WERE USED FOR TREATMENT OF HEAVILY CALCIFIED, 100% STENOSED, NON-TORTUOUS LESION IN RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH LEFT CONTRALATERAL FEMORAL ACCESS. THE VESSEL WAS PRIMARY WIRED WITH ABBOTT COMMAND WIRE AND EXCHANGED WITH THE VIPERWIRE. FOLLOWING TWELVE TO FIFTEEN TREATMENTS IN LOW, MEDIUM, AND HIGH SPEEDS, THE VIPERWIRE WAS OBSERVED TO BE FRACTURED AT THE SFA WHILE ITS SPRING TIP WAS IN PERONEAL ARTERY BELOW THE KNEE. THE VIPERWIRE FRAGMENT WAS SUCCESSFULLY SNARED WITH AN ABBOTT SURVEIL DRUG COATED BALLOON (DCB). THE VESSEL WAS REWIRED WITH ABBOTT COMMAND GUIDE WIRE. BALLOON ANGIOPLASTY WITH SURVEIL DCB WAS PERFORMED IN THE SFA WITH SATISFACTORY RESULTS. THE ATHERECTOMY WAS DEEMED COMPLETE. THE PATIENT WAS TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THERE IS NO INDICATION AS TO HOW THE FRACTURE OCCURRED AS THE PHYSICIAN HAS NOT SEEN IT PRIOR. THE OAD CROWN DID NOT JUMP AND CONTACT THE SPRING TIP. THERE WAS NO WIRE BIAS. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. THE PHYSICIAN HAS NO CONCERNS ABOUT PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725175 ↗
• InjuryMar 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 80% STENOSED SUPERFICIAL FEMORAL ARTERY (SFA), BEFORE THE INTERVENTION BEGAN, THE VIPERWIRE PERIPHERAL ADVANCE GUIDEWIRE WAS ADVANCED THROUGH A 45 CM NON-ABBOTT SHEATH. IT WAS NOTED THAT THE VESSEL WAS PRIMARILY WIRED WITH THE VIPERWIRE GUIDEWIRE. THE TIP OF THE WIRE BROKE OFF AS IT EXITED THE SHEATH AND THE TIP WAS RETRIEVED WITH A SNARE. A REPLACEMENT VIPERWIRE WAS USED WITH THE ORBITAL ATHERECTOMY SYSTEM AND A DRUG COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621817 ↗
• InjuryJun 28, 2024Material Separation; Material Separation

  THE TREATMENT AREA WAS A 3MM, 95% STENOSED, NO TORTUOSITY AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED WITHOUT ISSUE, THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN ONE TIME ONE TIME FOR TREATMENT. WHEN THE OAD AND VIPERWIRE WERE REMOVED, IT WAS OBSERVED THE SPRING TIP HAD FRACTURED BUT NO DAMAGE TO THE OAD DRIVESHAFT. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE FRACTURED COMPONENT. NO COMPONENTS WERE LEFT IN VIVO. THE PATIENT WAS STABLE. IT WAS UNCLEAR HOW THE VIPERWIRE FRACTURED. THERE WAS NO CROWN JUMPING OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632289 ↗
• InjuryJun 10, 2024Material Separation; Material Separation

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT AND THEN A VIPERWIRE ADVANCE GUIDE WIRE FRACTURE OCCURRED IN VIVO. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19498695 ↗
• InjurySep 13, 2023Material Separation; Material Separation

  A LOW SPEED AND MEDIUM SPEED TREATMENTS WERE PERFORMED IN THE PROXIMAL COMPLETE TOTAL OCCLUDED SUPERFICIAL FEMORAL ARTERY WITH A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). DURING THE HIGH SPEED TREATMENT, THE CROWN MADE A SOUND AS IF IT BECAME CAUGHT IN TISSUE AND WAS ABOUT TO STOP SPINNING, HOWEVER, IT CONTINUED TO SPIN. THE OAD WAS PULLED BACK TO THE PROXIMAL SFA TO COMPLETE TREATMENT, WHEN THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS OBSERVED TO BE FRACTURED. THE FRACTURED GUIDE WIRE WAS SUCCESSFULLY SNARED. THE PATIENT WAS STABLE AND DISCHARGED THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17736753 ↗
• MalfunctionJun 19, 2023Material Separation; Material Separation

  A NON-CSI DEVICE WAS EXCHANGED FOR A VIPERWIRE ADVANCE GUIDE WIRE IN A 99% STENOSED, SEVERELY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY (TA). A LOW SPEED AND MEDIUM SPEED TREATMENT WAS PERFORMED WITH A PERIPHERAL ORBITAL ATHERECTOMY DEVICE. A BALLOON WAS USED TO POST DILATE THE LESION. AN ATTEMPT WAS MADE TO EXCHANGE THE GUIDE WIRE, HOWEVER, THE TIP OF THE WIRE SEPARATED FROM THE SHAFT OF THE BALLOON. THE BALLOON AND WIRE WERE REMOVED WITH NO COMPONENTS LEFT IN VIVO. THE TIP OF THE BALLOON WAS CURLED AND THE TIP OF THE WIRE WAS WEDGED INSIDE OF THE BALLOON. THE VESSEL WAS RE-WIRED AND A NEW BALLOON WAS USED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153485 ↗
• InjuryMay 23, 2023Material Integrity Problem; Material Integrity Problem

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT OF THE POPLITEAL ARTERY, TIBIOPERONEAL TRUNK (TPT), AND PERONEAL ARTERY. ONE TREATMENT ON LOW SPEED WAS PERFORMED IN THREE TREATMENT SEGMENTS. THE OAD AND TIP OF THE DRIVESHAFT REMAINED GREATER THAN 100MM FROM THE SPRING TIP. DURING OAD REMOVAL, THE OAD PULLED THE VIPERWIRE ADVANCE GUIDE WIRE OUT OF POSITION. POST OAD TREATMENT, A JADE BALLOON WAS USED IN THE POPLITEAL AND A NON-CSI BALLOON WAS USED IN THE TPT AND PERONEAL. UPON REMOVAL OF THE BALLOON, THE SPRING TIP WAS NOTED TO BE SEPARATED FROM THE BODY OF THE VIPERWIRE. THE REMAINING VIPERWIRE WAS EXCHANGED FOR A NON-CSI WIRE. ADDITIONAL INTERVENTIONS WERE MADE WITH NON-CSI DEVICES. ANGIOGRAPHIC IMAGING WAS OBSERVED, AND A PERFORATION WAS NOTED IN THE DISTAL EXTERNAL ILIAC/PROXIMAL COMMON FEMORAL ARTERY (CFA). BALLOON TAMPONADE WAS UNSUCCESSFUL. THREE COVERED STENTS WERE PLACED IN THE DISTAL EXTERNAL ILIAC/PROXIMAL CFA WITH RESOLUTION OF CONTRAST EXTRAVASATION. THE VIPERWIRE SPRING TIP REMAINED IN THE DISTAL PERONEAL. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR FURTHER TESTING AND MONITORING. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 16989317 ↗
• InjuryApr 21, 2023Material Separation; Material Separation

  DURING A WIRE EXCHANGE, THE VIPERWIRE ADVANCE GUIDE WIRE FRACTURED IN A 100% STENOSED, HEAVILY CALCIFIED DISTAL TIBIAL ARTERY, AS IT WAS WEDGED IN PLAQUE. THE LESION WAS HEAVILY CALCIFIED AND 100% STENOSED. THE FRACTURED COMPONENT WAS ABLE TO BE SNARED AND RETRIEVED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16784918 ↗
• InjuryApr 13, 2023Material Separation; Material Separation

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT AN 100% OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING ATHERECTOMY AND BALLOON ANGIOPLASTY, THE PHYSICIAN CHECKED THE WIRE PLACEMENT AND OBSERVED THE TIP OF THE VIPERWIRE ADVANCE GUIDE WIRE HAD FRACTURED. THE FRACTURED TIP WAS STUCK IN AN EXISTING ENDOGRAFT. THE FRACTURED TIP WAS SUCCESSFULLY SNARED. THE PATIENT WAS STABLE AND DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16735781 ↗
• InjuryMar 23, 2023Material Separation; Material Separation

  FOLLOWING TREATMENT OF A SEVERELY CALCIFIED LESION, ANGIOGRAPHIC IMAGING REVEALED THE TIP OF THE VIPERWIRE ADVANCE GUIDE WIRE FRACTURED IN THE ANKLE IN THE POSTERIOR TIBIAL ARTERY. A NON-CSI SUPPORT CATHETER WAS USED TO RETRIEVE THE FRACTURED TIP. A SHEPHERD GUIDE WIRE WAS USED TO PERFORM BALLOON ANGIOPLASTY. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16600902 ↗