ViperWire Advance FlexTip VPR-GW-FT18Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10852528005329), received between May 19, 2016 and Mar 19, 2020 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2020Material Separation; Material Separation

  A NON-CSI FILTER WAS USED WITH A VIPERWIRE GUIDE WIRE. THE FILTER COULD NOT BE PULLED BACK INTO THE RETRIEVAL DEVICE. DURING REMOVAL OF THE FILTER AND WIRE TOGETHER, THE TIP OF THE VIPERWIRE FRACTURED. A STENT WAS DEPLOYED OVER THE FRAGMENT. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9856891 ↗
• InjuryMar 28, 2019Material Separation; Material Separation

  DURING A PERIPHERAL PROCEDURE, A NON-CSI FILTER WAS BEING USED OFF OF THE VIPERWIRE GUIDE WIRE. THE TARGET LESION WAS HIGHLY CALCIFIED, BUT NOT TOTALLY OCCLUDED, AND LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE LESION WAS TREATED SUCCESSFULLY, AN ATTEMPT WAS MADE TO RETRIEVE THE FILTER, AND THE GUIDE WIRE FRACTURED. A RETRIEVAL CATHETER WAS USED TO SNARE THE FILTER AND GUIDE WIRE FRAGMENT. NO DEVICE FRAGMENTS WERE LEFT IN THE PATIENT, HOWEVER, SOME CAPTURED MATERIAL WAS LOST DOWNSTREAM. IT WAS NOTED THAT THERE WAS NO UNUSUAL STRAIN ON THE GUIDE WIRE, AND THE ORBITAL ATHERECTOMY DEVICE (OAD) WAS NOT CLOSE TO THE FILTER OR THE END OF THE GUIDE WIRE AT ANY TIME DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY WITH NO ADDITIONAL PATIENT COMPLICATIONS. IT WAS NOTED THAT THE POSTERIOR TIBIAL ARTERY WAS ALSO SUCCESSFULLY TREATED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8460286 ↗
• InjurySep 14, 2018Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING AN ATHERECTOMY PROCEDURE WITH A PERIPHERAL VIPERWIRE AND COMPETITOR FILTER, THE WIRE AND FILTER BECAME STUCK AT THE END OF THE SHEATH. THE VIPERWIRE AND FILTER BOTH BROKE. THE WIRE FRAGMENT WAS RETRIEVED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7878168 ↗
• MalfunctionJun 1, 2018Detachment Of Device Component; Material Separation; Detachment Of Device Component; Material Separation

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE GUIDE WIRE BECAME DETACHED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND WAS TREATED USING THE OAD. A NON-CSI FILTRATION DEVICE WAS BEING UTILIZED WITH A NON-CSI SHEATH. UPON COMPLETION OF THE PROCEDURE WHEN ATTEMPTING TO REMOVE THE FILTER, THE TIP OF THE GUIDE WIRE BECAME DETACHED. THE WIRE FRAGMENT REMAINED WITHIN THE SHEATH AND ALL DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7562233 ↗
• InjuryApr 9, 2018Material Separation; Material Separation

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI VIPERWIRE GUIDE WIRE, THE TIP OF THE GUIDE WIRE BECAME DETACHED. THE TARGET LESION WAS 80% STENOSED AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE VIPERWIRE WAS BEING UTILIZED WITH A NON-CSI ATHERECTOMY DEVICE AND AN EMBOLIC FILTER SYSTEM. WHEN ATTEMPTING TO RETRIEVE THE EMBOLIC FILTER, THE TIP OF THE GUIDE WIRE BECAME DETACHED. THE WIRE FRAGMENT WAS SNARED AND REMOVED AND THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7407373 ↗
• InjuryNov 29, 2017Material Separation; Material Separation

  DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS REPORTED THAT THE GUIDEWIRE DETACHED AND REMAINED IN THE PATIENT. AFTER TREATMENT OF THE TARGET LESION USING THE OAD, THE WIRE WAS NOTED TO BE DETACHED. THE WIRE WAS UNABLE TO BE SNARED AND WAS SECURED AGAINST THE VESSEL WALL USING A STENT. THE PATIENT REMAINED STABLE DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7067338 ↗
• InjuryAug 15, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI VIPERWIRE GUIDE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN USED AN ABBOTT GUIDE WIRE AND A QUICKCROSS 0.014" GUIDE CATHETER TO ACCESS THE LESION. A DISTAL FILTRATION DEVICE WAS ADVANCED INTO THE PATIENT DISTAL TO THE LESION. THE ABBOTT GUIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND A CSI ORBITAL ATHERECTOMY WAS LOADED ONTO THE GUIDE WIRE. THE PHYSICIAN PERFORMED ONE RUN AT LOW SPEED, ONE RUN AT MEDIUM SPEED AND TWO RUNS AT HIGH SPEED. WHILE REMOVING THE OAD, THE PHYSICIAN DISCOVERED THAT THE TIP OF THE GUIDE WIRE HAD BROKEN OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE FILTER FROM THE PATIENT, BUT THE TIP OF THE WIRE STILL REMAINED IN A BRANCH OF THE PERONEAL ARTERY. THE WIRE WAS STENTED AGAINST THE VESSEL WALL TO PREVENT IT FROM MIGRATING DISTALLY. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6794897 ↗
• MalfunctionMar 30, 2017Device Misassembled During Manufacturing /Shipping; Compatibility Problem; Incorrect Device Or Component Shipped; Device Misassembled During Manufacturing /Shipping; Compatibility Problem; Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, AN ABBOTT NAV6 EMBOLIC PROTECTION DEVICE SLID OFF THE END OF A CSI 0.018" VIPERWIRE GUIDE WIRE WHEN REMOVING IT FROM THE PATIENT. THE PHYSICIAN SUCCESSFULLY COMPLETED ATHERECTOMY, BUT IT WAS NOTED THAT THE DISTAL TIP OF THE OAD WAS BEING BROUGHT INTO CONTACT WITH THE FILTER DURING TREATMENT. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FILTER WITH THE GUIDE WIRE, HE WAS UNSUCCESSFUL. THE VIPERWIRE GUIDE WIRE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN WAS THEN ABLE TO RETRIEVE THE FILTER WITH A SNARE DEVICE. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6447444 ↗
• MalfunctionMar 30, 2017Device Misassembled During Manufacturing /Shipping; Compatibility Problem; Incorrect Device Or Component Shipped; Device Misassembled During Manufacturing /Shipping; Compatibility Problem; Incorrect Device Or Component Shipped

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, AN ABBOTT NAV6 EMBOLIC PROTECTION DEVICE SLID OFF THE END OF A CSI 0.018" VIPERWIRE GUIDE WIRE WHEN REMOVING IT FROM THE PATIENT. THE PHYSICIAN HAD ADVANCED THE VIPERWIRE GUIDE WIRE AND FILTER INTO THE PATIENT, AND LOADED A CSI ORBITAL ATHERECTOMY DEVICE ONTO THE GUIDE WIRE. THE PHYSICIAN SUCCESSFULLY COMPLETED ATHERECTOMY AND REMOVED THE OAD FROM THE PATIENT. THE VIPERWIRE GUIDE WIRE WAS PULLED BACK UNTIL THE DISTAL TIP WAS JUST DISTAL TO THE FILTER. WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FILTER WITH THE GUIDE WIRE, HE WAS UNSUCCESSFUL. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN WAS THEN ABLE TO RETRIEVE THE FILTER WITH A SNARE DEVICE. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6447437 ↗
• InjuryFeb 21, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI VIPERWIRE GUIDE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESION WAS 30CM IN LENGTH, 100% STENOTIC AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN ADVANCED A CSI VIPERWIRE GUIDE WIRE ACROSS THE LESION AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN COMPLETED ONE RUN WITH A 1.50MM SOLID CROWN OAD AND THEN CONTINUED TREATMENT WITH A 2.00MM SOLID CROWN OAD. WHILE REMOVING THE OAD FROM THE PATIENT, THE TIP OF THE GUIDE WIRE BROKE OFF IN THE PATIENT. THE PHYSICIAN FOLLOWED UP WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT IN ORDER TO PIN THE GUIDE WIRE TIP AGAINST THE VESSEL WALL. THE PATIENT LEFT THE PROCEDURE IN STABLE CONDITION. ONE REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE BUT NONE HAS BEEN RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6345978 ↗
• InjuryMay 19, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI VIPERWIRE GUIDE WIRE BROKE OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESION ORIGINATED IN THE TIBIO-PERONEAL TRUNK (TPT) AND EXTENDED INTO THE POSTERIOR TIBIAL (PT) ARTERY. THE PHYSICIAN USED A 6FR INTRODUCER SHEATH AND A 0.014 GLIDEWIRE GUIDE WIRE TO ACCESS THE LESION. THE GLIDEWIRE WAS EXCHANGED FOR THE CSI VIPERWIRE GUIDE WIRE AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO THE WIRE. AS THE OAD WAS BEING ADVANCED OVER THE GUIDE WIRE, THE PHYSICIAN OBSERVED THAT THE TIP OF THE GUIDE WIRE WAS WITHIN THE OAD DRIVESHAFT. THE GUIDE WIRE WAS ADVANCED DISTALLY AND THE OAD WAS THEN ADVANCED FURTHER. HOWEVER, THE PHYSICIAN AGAIN OBSERVED THAT THE TIP OF THE GUIDE WIRE WAS WITHIN THE OAD DRIVESHAFT. THE OAD WAS REMOVED, BUT WHILE RE-POSITIONING THE GUIDE WIRE, THE PHYSICIAN NOTED THAT THE TIP HAD BROKEN OFF AND MIGRATED DISTALLY. THE PHYSICIAN EXCHANGED THE VIPERWIRE FOR A 0.014 NITREX GUIDE WIRE AND ADVANCED A STENT OVER IT. THE STENT WAS DEPLOYED IN THE AREA OF THE BROKEN VIPERWIRE TIP IN ORDER TO PIN IT AGAINST THE VESSEL WALL. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDUR

  Patient problems: Foreign Body In Patient

  MAUDE report 5667364 ↗