ViperWire, Advance VPR-GW-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10852528005077), received between Feb 22, 2016 and Apr 9, 2026 — classified as 35 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (38 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Difficult to Remove

  IT WAS REPORTED THAT THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED RIGHT SUPERFICIAL FEMORAL ARTERY (RSFA). A 6 X 45 SHEATH WAS IN USE. TREATMENTS WERE PERFORMED ON LOW AND MEDIUM SPEEDS. DURING THE HIGH-SPEED TREATMENT, THE OAD STALLED WHEN BEING PULLED BACK. THE OAD BECAME STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. THE OAD AND VIPERWIRE WERE REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE DRIVESHAFT OR VIPERWIRE. THE PATIENT WAS STABLE. IT WAS UNKNOWN IF THE ISSUE WAS WITH THE OAD OR VIPERWIRE. THERE WAS NO CLEAR INDICATION AS TO WHY THE OAD STALLED BUT THE TECHNICIAN STATED THAT THE PHYSICIAN DOES NOT HAVE X-RAY ON WHILE SPINNING AND MAY HAVE RUN OVER THE DISTAL VIPERWIRE TIP. DURING DEVICE ANALYSIS, A GUIDE WIRE FRACTURE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830921 ↗
• InjuryFeb 23, 2026Entrapment of Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, NON-TORTUOUS, 80% STENOSED RIGHT PERONEAL ARTERY AND MODERATELY CALCIFIED, NON-TORTUOUS, 95% STENOSED ANTERIOR TIBIAL ARTERY (AT). A 5 FR NON-ABBOTT SHEATH WAS IN USE. A LESION IN THE PERONEAL HAS BEEN SUCCESSFULLY TREATED WITH THE OAD. THE PHYSICIAN PLANNED TO TREAT THE AT, BUT THE X-RAY MACHINE WENT DOWN. THE X-RAY WAS REBOOTED. ANGIOGRAPHIC IMAGES REVEALED THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS BENT IN MULTIPLE PLACES. IT WAS UNKNOWN WHAT LED TO THE VIPERWIRE DAMAGE. THE VIPERWIRE WAS SO BENT THEY COULD NOT GET IT BACK THROUGH THE SHEATH TO REMOVE IT. ANOTHER UNSPECIFIED WIRE WAS USED AND WITHDREW THE SHEATH AND VIPERWIRE TOGETHER BUT AS IT WAS COMING OUT OF THE BODY THE VIPERWIRE COULD NOT GET THROUGH AND GOT CAUGHT IN THE COMMON FEMORAL ARTERY (CFA) ARTERIAL WALL. THE SHEATH WAS REMOVED. A 5FR NON-ABBOTT DILATOR WAS USED TO REMOVE THE VIPERWIRE; THE STIFFNESS OF THE DILATOR HELPED STRAIGHTEN THE KINK TO ALLOW REMOVAL. A SECOND VIPERWIRE WAS INSERTED TO CONTINUE TREATMENT, BUT THE X-RAY MACHINE DIED AGAIN. THE PROCEDURE WAS ABORTED DUE TO THE X-RAY FAILING CONTINUOUSLY. THE PATIENT WAS STABLE. IT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24421720 ↗
• InjurySep 8, 2025Material Separation; Material Separation

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A TIBIOPERONEAL TRUNK (TP), POPLITEAL ARTERY, AND MID SUPERFICIAL FEMORAL ARTERY (SFA). AFTER FOUR TREATMENTS, THE PATIENT LIFTED THEIR LEG AND FLEXED THEIR HIP, RESULTING IN VIPERWIRE GUIDE WIRE WIRE BIAS. THE OAD WAS POWERED OFF. THE OAD WAS BEING REMOVED WITH GREAT RESISTANCE, THUS THE PHYSICIAN DECIDED TO REMOVE THE OAD AND VIPERWIRE TOGETHER. EX-VIVO IT WAS DETERMINED THE VIPERWIRE FRACTURED AND 80 CENTIMETERS REMAINED IN THE SFA AND MIGRATED TO THE PERONEAL ARTERY. THE FRACTURED COMPONENT WAS ABLE TO BE RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. THE CAUSE OF THE FRACTURE WAS DETERMINED TO BE DUE TO THE PATIENT MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992186 ↗
• InjuryJun 11, 2025Material Separation; Device Damaged by Another Device; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WERE USED FOR TREATMENT OF SEVERELY CALCIFIED, NON-TORTUOUS, 90% STENOSED LESION IN LEFT DISTAL SUPERFICIAL ARTERY (SFA) TO POPLITEAL ARTERY THROUGH FEMORAL ARTERY ACCESS. THE UNSPECIFIED PRIMARY WIRE WAS EXCHANGED WITH THE VIPERWIRE. TREATMENT STARTED ON LOW SPEED, FOLLOWED BY TWO TO THREE TREATMENTS ON MEDIUM THEN THREE TREATMENTS ON HIGH SPEED. BALLOON ANGIOPLASTY USING ABBOTT SURVEIL DRUG-COATED BALLOON (DCB) WAS PERFORMED. ANGIOGRAPHIC IMAGING POST DCB ANGIOPLASTY REVEALED VIPERWIRE FRACTURED TIP IN THE TIBIOPERONEAL (TP) TRUNK. THE FACTURE OCCURRED ONE CM FROM THE MARKER, AND APPROXIMATELY HALF OF THE RADIOPAQUE TIP BROKE. THE FRACTURED COMPONENT WAS SUCCESSFULLY SNARED. THE PHYSICIAN BELIEVES THEY SPUN TOO CLOSE TO THE DISTAL VIPERWIRE AS THE TIP OF THE VIPERWIRE WAS OFF THE SCREEN DURING TREATMENTS. THE PATIENT WAS STABLE. THERE WAS NO OAD CROWN JUMP OR VIPERWIRE BIAS. NO DAMAGE/ISSUES PRIOR TO SEPARATION WERE OBSERVED. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "TIP OF WIRE BROKE OFF INSIDE OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184062 ↗
• MalfunctionMar 17, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE TREATMENT AREA WAS A 85% STENOSED, MODERATELY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY. AFTER TREATMENT WITH THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE WIRE BRAKE WAS RELEASED AND AN ATTEMPT WAS MADE TO REMOVE THE OAD. THE OAD WAS STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDEWIRE AND COULD NOT RELEASE. TROUBLESHOOTING WAS PERFORMED BY LOCKING AND UNLOCKING THE BRAKE IN AN ATTEMPT TO RELEASE THE OAD FROM THE WIRE, BUT WAS UNSUCCESSFUL. THE OAD AND THE GUIDEWIRE WERE REMOVED TOGETHER, AND THE LESION WAS WIRED AGAIN TO COMPLETE THE PROCEDURE. THE RETURNED PRODUCT TO THE MANUFACTURER SHOWED BLOOD BACKED UP INTO THE OAD AND DEVICE ANALYSIS IDENTIFIED MATERIAL SEPARATION OF THE GUIDEWIRE SPRING TIP. IT WAS NOTED THAT THE FORWARD SALINE FLOW WAS NOT STOPPED AT ANY TIME DURING THE PROCEDURE AND PUMP WAS NOT TURNED OFF PRIOR TO REMOVAL OF THE OAD. IN THE OPINION OF THE PHYSICIAN, THE FLOW WAS SUFFICIENT TO AVOID INJURY TO THE PATIENT. THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21622175 ↗
• InjuryJul 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A .014 INCH VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS USED FOR TREATMENT OF A HIGHLY CALCIFIED, 80% STENOSED LESION IN LEFT ANTERIOR TIBIAL ARTERY. THE VESSEL DIAMETER WAS 3MM. THE NURSE OPENED THE VIPERWIRE AND HANDED IT TO THE TECHNICIAN. THE TECHNICIAN INSERTED THE VIPERWIRE INTO THE PATIENT. THE NURSE WENT TO SCAN THE VIPERWIRE AND REALIZED IT WAS EXPIRED. THE VIPERWIRE WAS REMOVED AFTER BEING IN VIVO FOR 60 SECONDS AND DISCARDED. A .018 INCH NON-ABBOTT SUPPORT CATHETER WAS INSERTED THEN EXCHANGED WITH A TAPERED VIPERWIRE WITH A GOOD EXPIRATION DATE. THE PATIENT WAS TREATED WITH A DOSE OF ANTIBIOTICS IN THE MIDDLE OF THE PROCEDURE TO PREVENT INFECTION FROM THE EXPIRED VIPERWIRE. THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810368 ↗
• InjuryMar 11, 2024Material Separation; Material Separation

  THE VIPERWIRE ADVANCE GUIDE WIRE TIP FRACTURED IN VIVO. A SNARE WAS USED TO REMOVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION AND DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18874772 ↗
• InjuryNov 20, 2023Material Separation; Material Separation

  THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE FRACTURED DURING REMOVAL AFTER TREATMENT OF THE POPLITEAL ARTERY. THE PHYSICIAN STATED THEY TREATED WITH THE ORBITAL ATHERECTOMY DEVICE (OAD) WITHIN 1 CENTIMETER FROM THE SPRING TIP BUT DID NOT MAKE CONTACT WITH THE WIRE. A SNARE WAS USED TO RETRIEVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18173950 ↗
• InjuryMay 17, 2023Material Separation; Material Separation

  THE VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED THROUGH A TELEPORT CATHETER INTO THE PEDAL VESSELS. THE WIRE WAS ADVANCED INTO A DISTAL, SIDE BRANCH OF THE PEDAL VESSELS AND THE TIP OF THE GUIDE WIRE FRACTURED UPON PULLING BACK THE WIRE. THE GUIDE WIRE WAS REPLACED. UPON COMPLETING THE PROCEDURE, THE REPLACEMENT GUIDE WIRE CAUGHT ONTO THE FRACTURED TIP AND REMOVED THE COMPONENT. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16950542 ↗
• InjuryJan 6, 2023Material Separation; Material Separation

  A DIAMONDBACK 360 PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 5MM, CALCIFIED LESION IN THE MID POPLITEAL. THERE WAS A PREVIOUSLY PLACED STENT IN THE DISTAL SIDE OF THE POPLITEAL. THE VIPERWIRE ADVANCE GUIDE WIRE WAS PLACED IN THE DISTAL SIDE OF THE STENT. THE OAD WAS USED TO BEGIN TREATMENT OF THE MID POPLITEAL. AFTER TWO OR THREE TREATMENTS, THE OAD WAS ADVANCED TOO CLOSE TO THE VIPERWIRE AND FRACTURED THE SPRING TIP, AS THE VIPERWIRE WAS UNABLE TO BE ADVANCED MORE DISTALLY. THE SPRING TIP WAS SNARED. A NEW VIPERWIRE AND NON-CSI DEVICES WERE USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16113825 ↗
• MalfunctionOct 7, 2022Material Separation; Material Separation

  FOLLOWING ATHERECTOMY TREATMENT FOR CALCIFIED VESSELS, WHILE REMOVING THE VIPERWIRE ADVANCE GUIDE WIRE THROUGH A NON-CSI CATHETER, THE TIP FRACTURED. THE TIP FRAGMENT SEPARATED INSIDE THE BALLOON CATHETER. THE PHYSICIAN REMOVED THE BALLOON AND WIRE. THE PATIENT EXPERIENCED NO COMPLICATION RESULTING FROM THIS EVENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15566486 ↗
• InjuryNov 24, 2021Material Separation; Material Separation

  ORBITAL ATHERECTOMY (OA) TREATMENT WAS PERFORMED TO THE MID AND DISTAL SUPERFICIAL FEMORAL ARTERY FOR SEVEN TREATMENT PASSES. FOLLOWING OA, IMAGING REVEALED THAT APPROXIMATELY 15MM OF THE RADIOPAQUE PORTION OF THE VIPERWIRE GUIDE WIRE HAD FRACTURED. THE TIP OF THE GUIDE WIRE REMAINED DISTAL FROM THE CROWN OF THE ORBITAL ATHERECTOMY DEVICE. THE FRAGMENT WAS RETRIEVED WITH A SNARE DEVICE AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12869653 ↗
• InjuryNov 9, 2021Material Separation; Material Separation

  DURING TREATMENT OF A LESION IN THE ANTERIOR TIBIAL ARTERY, THE VIPERWIRE GUIDE WIRE ADVANCED DEEPER THAN ORIGINALLY POSITIONED. WHEN THE ORBITAL ATHERECTOMY DEVICE WAS STOPPED AND REPOSITIONED, IT WAS NOTED THAT THE TIP OF THE WIRE WAS NOT MOVING SYNCHRONOUSLY. THE VIPERWIRE WAS RETRACTED AND OBSERVED TO HAVE FRACTURED. THE FRACTURE OCCURRED IN THE AREA OF THE PROXIMAL SUPERFICIAL FEMORAL ARTERY, PARTIALLY IN THE SHEATH. A SMALL BALLOON WAS ADVANCED AND USED TO TRAP THE FRACTURED WIRE IN THE DISTAL SECTION OF THE SHEATH. THE SHEATH AND WIRE WERE THEN REMOVED AND REPLACED TO CONTINUE THE PROCEDURE WITH NO PATIENT ISSUES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12782789 ↗
• InjuryNov 8, 2021Material Separation; Device-Device Incompatibility; Material Separation; Device-Device Incompatibility

  A PERIPHERAL GUIDE WIRE WAS INADVERTENTLY INSERTED INTO A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). WHEN TESTED OUTSIDE OF THE PATIENT, WITH THE BRAKE LEVER LOCKED, A PIECE OF THE WIRE FRACTURED IN VIVO. THE OAD WAS REMOVED AND NO ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENT AS IT WAS LODGED IN A DISTAL SEPTAL ARTERY. THE PROCEDURE WAS CONTINUED WITH A SECOND OAD AND CORONARY GUIDE WIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12770853 ↗
• InjuryNov 4, 2021Entrapment of Device; Material Separation; Device-Device Incompatibility; Entrapment of Device; Material Separation; Device-Device Incompatibility

  DURING A CORONARY PROCEDURE, A VIPERWIRE PERIPHERAL GUIDE WIRE WAS MISTAKENLY USED WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). WHEN THE OAD WAS TESTED OUTSIDE THE PATIENT, IT BECAME STUCK ON THE GUIDE WIRE. FOLLOWING REMOVAL OF THE OAD, IT WAS OBSERVED VIA FLUOROSCOPY THAT THE TIP OF THE WIRE HAD FRACTURED DURING TESTING. NO ATTEMPT WAS MADE TO RETRIEVE THE WIRE FRAGMENT AND IT WAS LEFT IN THE DISTAL SEPTAL ARTERY. THE PROCEDURE WAS CONTINUED WITH NON-CSI ATHERECTOMY TREATMENT AND THE PATIENT STATUS WAS GOOD.

  Patient problems: Foreign Body In Patient

  MAUDE report 12752889 ↗
• InjuryAug 10, 2021Material Separation; Material Separation

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT THE ANTERIOR TIBIAL ARTERY, FOLLOWING WHICH THE VIPERWIRE GUIDE WIRE WAS REPOSITIONED TO THE POSTERIOR TIBIAL ARTERY. THREE TREATMENT PASSES WERE PERFORMED, FOLLOWED BY BALLOON ANGIOPLASTY. WHEN THE BALLOON WAS RETRACTED, IT WAS NOTED THAT THE TIP OF THE VIPERWIRE GUIDE WIRE HAD FRACTURED. THE PHYSICIAN DECIDED TO LEAVE THE WIRE FRAGMENT IN THE FOOT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12300933 ↗
• InjuryJun 30, 2021Material Separation; Material Separation

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED FOR TEN TREATMENT PASSES WITHOUT ISSUE. AFTER REMOVAL OF THE VIPERWIRE GUIDE WIRE, IT WAS OBSERVED THAT A PORTION OF THE GUIDE WIRE REMAINED IN THE PATIENT. A SNARE DEVICE WAS USED TO RETRIEVE THE FRAGMENT, HOWEVER PART OF THE WIRE TIP COULD NOT BE RETRIEVED AND IT WAS LEFT IN VIVO. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12091601 ↗
• InjuryJun 10, 2021Off-Label Use; Material Separation; Off-Label Use; Material Separation

  A PERIPHERAL VIPERWIRE GUIDE WIRE WAS INADVERTENTLY INSERTED INTO A CORONARY ORBITAL ATHERECTOMY DEVICE. IT WAS REPORTED THAT THE LABELING ON THE WIRE PACKAGING WAS NOT CLEAR. AN UNUSUAL SOUND WAS NOTED DURING TESTING, AND DURING ATTEMPTS TO REMOVE THE OAD FROM THE GUIDE WIRE THE WIRE FRACTURED IN VIVO. AFTER OVER TWO HOURS OF UNSUCCESSFUL ATTEMPTS TO SNARE THE WIRE, THE FRAGMENT WAS STENTED AGAINST THE VESSEL WALL. THE PROCEDURE WAS CONTINUED WITH A CORONARY GUIDE WIRE AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11974385 ↗
• InjuryMay 12, 2021Material Separation; Material Separation

  TREATMENT WITH THE ORBITAL ATHERECTOMY SYSTEM WAS PERFORMED ON A HEAVILY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ORBITAL ATHERECTOMY WAS COMPLETED WITH ONE TREATMENT EACH ON LOW, MEDIUM, AND HIGH SPEEDS, IT WAS OBSERVED THAT A SMALL PORTION OF THE VIPERWIRE GUIDE WIRE SPRING TIP HAD FRACTURED. THE FRAGMENT WAS TOO SMALL TO RETRIEVE VIA SNARE, SO THE FRAGMENT WAS STENTED TO THE VESSEL WALL. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11815546 ↗
• InjuryMar 23, 2021Material Separation; Material Separation

  THE TIP OF THE VIPERWIRE GUIDE WIRE FRACTURED DURING USE IN THE SUPERFICIAL FEMORAL ARTERY VIA GROIN ACCESS. THE FRAGMENT WAS SNARED. THE USER INDICATED THE ATHERECTOMY DEVICE MAY HAVE ENCOUNTERED THE SPRING TIP OF THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11554903 ↗
• InjuryMar 1, 2021Material Twisted/Bent; Material Twisted/Bent

  A VIPERWIRE GUIDE WIRE WAS SELECTED FOR USE WITH AN ORBITAL ATHERECTOMY DEVICE (OAD) FOR TREATMENT OF MODERATELY CALCIFIED, 80% STENOSED LESION IN THE MID ANTERIOR TIBIAL ARTERY. ORBITAL ATHERECTOMY WAS SUCCESSFULLY COMPLETED, AND THE VIPERWIRE WAS OBSERVED TO BE BENT AT THE DISTAL END. THE OAD WAS REMOVED AND AN ATTEMPT WAS MADE TO REMOVE THE VIPERWIRE. A NEW, LONGER CATHETER WAS OPENED TO REMOVE THE VIPERWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11395218 ↗
• InjuryFeb 5, 2021Material Separation; Material Separation

  A PERIPHERAL VIPERWIRE GUIDE WIRE WAS INADVERTENTLY USED WITH A CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). THE 99% STENOSED, HIGHLY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE, THE OAD BECAME STUCK ON THE PERIPHERAL WIRE. THE DEVICE WAS REMOVED, AND THE SPRING TIP OF THE VIPERWIRE HAD FRACTURED AND REMAINED IN THE VESSEL. THE VESSEL WAS TREATED WITH BALLOON ANGIOPLASTY. THE SPRING TIP FRAGMENT HAD FRACTURED INTO THREE PIECES. AN ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENTS, WHICH WAS UNSUCCESSFUL. THE FRAGMENTS WERE STENTED TO THE VESSEL WALL WITH THREE STENTS. THE PATIENT EXPERIENCED CHEST PAIN BUT WAS STABLE AT THE COMPLETION OF THE PROCEDURE. NO ADDITIONAL INTERVENTION WAS PERFORMED FOR THE CHEST PAIN, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

  Patient problems: Foreign Body In Patient

  MAUDE report 11288741 ↗
• InjuryJan 27, 2021Material Separation; Material Separation

  THE PERIPHERAL VIPERWIRE GUIDE WIRE WAS USED WITH A NON-CSI ATHERECTOMY DEVICE FOR TREATMENT OF A LESION IN THE ANTERIOR TIBIAL ARTERY. THE LESION WAS 300MM LONG. THE BRAKE OF THE NON-CSI ATHERECTOMY DEVICE WAS CRACKED, THE VIPERWIRE WAS MANUALLY HELD, AND THE DISTAL END OF THE VIPERWIRE TORQUED AND BECAME COILED. THE VIPERWIRE BROKE INTO FOUR FRAGMENTS. ONE FRAGMENT WAS ABLE TO BE RETRIEVED, AND THE OTHER THREE, 1-2MM FRAGMENTS REMAINED IN THE VESSEL. A PERFORATION WAS OBSERVED IN THE DORSALIS PEDIS AFTER FRAGMENT REMOVAL. THE CAUSE OF THE PERFORATION WAS UNKNOWN, HOWEVER, THE PHYSICIAN THOUGHT THE TORQUING OF THE VIPERWIRE MAY HAVE CONTRIBUTED. A SECOND VIPERWIRE WAS PLACED AT THE LESION, AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY.

  Patient problems: Foreign Body In Patient; Perforation of Vessels

  MAUDE report 11240056 ↗
• InjuryDec 23, 2020Material Separation; Material Separation

  ORBITAL ATHERECTOMY TREATMENT WAS SUCCESSFULLY PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY, AND THE PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS REMOVED FROM THE PATIENT. MULTIPLE BALLOONS WERE INSERTED OVER THE VIPERWIRE GUIDE WIRE AND BALLOON ANGIOPLASTY WAS PERFORMED. THE BALLOONS AND WIRE WERE REMOVED FROM THE PATIENT. AN ANGIOGRAM WAS PERFORMED AND REVEALED THAT PART OF THE GUIDE WIRE HAD FRACTURED AND REMAINED IN THE SHEATH. THE FRAGMENT WAS RETRIEVED FROM THE SHEATH WITH A SNARE DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS DESCRIBED AS "FINE."

  Patient problems: Foreign Body In Patient

  MAUDE report 11064551 ↗
• InjuryNov 22, 2020Material Separation; Material Separation

  PROXIMAL TO DISTAL TREATMENT WITH A VIPERWIRE GUIDE WIRE WAS PERFORMED IN THE PERONEAL ARTERY. IMAGING SHOWED VESSEL SPASM, BUT TREATMENT WAS CONTINUED. DUE TO AN ISSUE WITH THE ATHERECTOMY DEVICE, THE VIPERWIRE WAS PULLED BACK, AND THE TIP OF THE WIRE FRACTURED. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE FRAGMENT. THE PATIENT MADE A FULL RECOVERY FOLLOWING REMOVAL OF THE FRAGMENTS. IN THE OPINION OF THE PHYSICIAN, THE CROWN SELECTED WAS TOO BIG FOR THE VESSEL, AND OA SHOULD NOT HAVE BEEN USED DURING SPASM.

  Patient problems: Foreign Body In Patient

  MAUDE report 10881617 ↗