ViperWire Advance FlexTip VPR-GW-FT14Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10852528005312), received between Nov 24, 2015 and Jan 29, 2020 — classified as 79 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (74 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2020Material Separation; Material Separation

  THE SPRING TIP OF THE VIPERWIRE GUIDE WIRE FRACTURED FOLLOWING THREE ATHERECTOMY TREATMENTS IN THE POSTERIOR TIBIAL ARTERY, WHICH WAS APPROXIMATELY 2.0MM IN DIAMETER AND WAS MODERATELY CALCIFIED. THE FRAGMENT WAS REMOVED WITH A SNARE. THERE WERE NO COMPLICATIONS AS A RESULT OF THE FRACTURE OR RETRIEVAL, AND ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED OVER A COMPETITOR WIRE FOLLOWING REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 9644302 ↗
• MalfunctionAug 7, 2019Material Separation; Material Separation

  DURING A PERIPHERAL PROCEDURE, THE TIP OF THE VIPERWIRE GUIDE WIRE FRACTURED AND WAS CAUGHT ON THE SUPPORT CATHETER. THE TARGET 100% STENOSED, SEVERELY CALCIFIED LESION WAS LOCATED IN THE POPLITEAL ARTERY. THE LESION WAS 60MM IN LENGTH AND LOCATED IN A NON-TORTUOUS SECTION OF THE ARTERY THAT WAS 5.5MM IN DIAMETER. DURING THE PROCEDURE, THE MICROCATHER WAS NOT ABLE TO TRAVERSE TO THE LESION, AND THE VIPERWIRE WAS USED TO ATTEMPT TO FINISH CROSSING. THE VIPERWIRE WAS UNABLE TO CROSS THE LESION, AND MAY HAVE BEEN TORQUED WHEN ATTEMPTING TO CROSS. WHEN CROSSING WAS UNSUCCESSFUL, THE VIPERWIRE WAS PULLED BACK INTO THE MICROCATHETER AND THE VIPERWIRE FRACTURED. THE FRACTURED SPRING TIP REMAINED IN THE MICROCATHETER AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND VIPERWIRE GUIDE WIRE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8871427 ↗
• InjuryJul 23, 2019Material Separation; Material Separation

  IT WAS REPORTED TO CSI VIA MEDWATCH (B)(4) THAT A PSEUDOANEURYSM WAS OBSERVED FOLLOWING RETRIEVAL OF THE GUIDE WIRE CORE WIRE, AND IT WAS TREATED WITH A BALLOON AND TWO OVERLAPPING STENTS. THIS EVENT WAS ORIGINALLY REPORTED TO CSI AS A PERFORATION, HOWEVER THE MEDWATCH REPORT OF THE PSEUDOANEURYSM WAS FROM THE PHYSICIAN'S CASE REPORT. IT IS ASSUMED THAT THE ORIGINAL EVENT ASSESSMENT CHANGED UPON FURTHER SITE REVIEW AS A PERFORATION WAS NOT REPORTED ON THE MEDWATCH.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Perforation of Vessels; Pseudoaneurysm

  MAUDE report 8818323 ↗
• InjuryJun 4, 2019Material Separation; Material Separation

  A PERIPHERAL PROCEDURE WAS PERFORMED WITH A CSI ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE. TARGET LESIONS THAT WERE NEARLY 100% STENOSED WERE LOCATED IN NON-TORTUOUS SECTIONS OF THE DISTAL POPLITEAL, PERONEAL, POSTERIOR TIBIAL, AND ANTERIOR TIBIAL ARTERIES. THE LESIONS WERE 5CM LONG IN THE POPLITEAL ARTERY AND 10CMS IN THE REMAINING ARTERIES. AFTER ATHERECTOMY HAD BEEN COMPLETED AND THE OAD REMOVED, A SCORING BALLOON WAS PASSED OVER THE VIPERWIRE. IT WAS NOTED THAT APPROPRIATE TECHNIQUE WAS NOT PERFORMED AS THERE WAS DIFFICULTY PUSHING THE BALLOON CATHETER DUE TO ADDED SLACK IN THE GUIDE WIRE. AFTER THE USE OF THE SCORING BALLOON WAS COMPLETED, IT WAS OBSERVED THAT THE VIPERWIRE TIP HAD BROKEN OFF AND WAS LOCATED IN A SIDE BRANCH. THE PHYSICIAN MADE THE DECISION TO NOT ATTEMPT TO SNARE NOR REMOVE THE VIPERWIRE, AND THE FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8666740 ↗
• InjuryApr 23, 2019Material Separation; Material Separation

  THE TIP OF THE VIPERWIRE FRACTURED IN THE ANTERIOR TIBIAL ARTERY DURING USE. THE FRAGMENT WAS SNARED AND REMOVED FROM THE PATIENT. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8540872 ↗
• InjuryApr 5, 2019Material Separation; Material Separation

  A MODERATELY CALCIFIED, 95% STENOSED LESION WAS LOCATED IN MILDLY TORTUOUS AREA OF THE POSTERIOR TIBIAL (PT) ARTERY BEYOND THE LEVEL OF THE ANKLE. THE LESION WAS 3.5 CM IN LENGTH AND THE VESSEL WAS 1.5-2 MM. THE VIPERWIRE GUIDE WIRE WAS ADVANCED PAST THE HEEL AND APPEARED TO BE LOCATED IN A LUMINAL PLANE. THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED 2-3 MM PROXIMAL TO THE LESION. THE OAD WAS TURNED ON AT LOW SPEED, AND THE CROWN JUMPED FORWARD ON THE GUIDE WIRE AND STOPPED SPINNING. AN ATTEMPT WAS MADE TO REMOVE THE OAD FROM THE GUIDE WIRE; HOWEVER, THE DEVICES WERE STUCK TOGETHER AND UNABLE TO BE REMOVED USING CONSIDERABLE FORCE. A NON-CSI GUIDE WIRE WAS ADVANCED IN AN ATTEMPT TO LOOSEN THE CROWN FROM THE VESSEL WALL, BUT THIS WAS UNSUCCESSFUL. A CORONARY BALLOON WAS USED TO ATTEMPT TO CREATE SPACE IN THE REMOVAL OF THE DEVICE, BUT THE DEVICE REMAINED STUCK. THE SALINE SHEATH OF THE OAD DRIVESHAFT WAS CUT AT THE STRAIN RELIEF OF THE OAD. THE SALINE SHEATH WAS ADVANCED OVER THE CROWN OF THE OAD, AND THE OAD AND GUIDE WIRE WERE SUCCESSFULLY REMOVED. IT WAS OBSERVED AFTER THE DEVICES WERE REMOVED THAT A PORTION APPROXIMATELY 7 CM OF THE SPRING TIP OF THE G

  Patient problems: Device Embedded In Tissue or Plaque; Vascular System (Circulation), Impaired

  MAUDE report 8488455 ↗
• InjuryMar 26, 2019Material Separation; Material Separation

  THREE SUCCESSFUL TREATMENTS WERE ADMINISTERED WITH THE ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE IN THE ANTERIOR TIBIAL VESSEL, WHICH WAS 90% STENOTIC WITH SEVERE CALCIFICATION. THE OAD WAS NOT SPUN NEAR THE TIP OF THE VIPERWIRE. THE TIP OF THE VIPERWIRE FRACTURED DURING USE AND WAS SNARED. THERE WAS NO PATIENT HARM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8451344 ↗
• InjuryMar 6, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  RELATED MANUFACTURER REFERENCE NUMBER: 3004742232-2019-00068. IT WAS REPORTED TO CSI VIA MEDWATCH MW5083148 THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE, A DEVICE MALFUNCTION OCCURRED. THE TARGET LESION WAS LOCATED BELOW THE KNEE IN A TIBIAL ARTERY, AND WAS TREATED WITH 2-3 PASSES OF THE OAD. FOLLOWING THE TREATMENT, IT WAS NOTED THAT FLUID WAS LEAKING FROM THE DEVICE TUBING BELOW THE CONNECTION TO THE SALINE PUMP. CONCERN WAS EXPRESSED BY THE STAFF THAT NO FLUID HAD BEEN FLOWING THROUGH THE DEVICE DURING TREATMENT. NON-CSI SALINE TUBING WAS USED IN AN ATTEMPT TO CORRECT THE LEAK, ALTHOUGH IT IS UNCLEAR IF THIS WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS REQUESTED FOR THIS EVENT, HOWEVER THE SITE DECLINED TO PROVIDE IT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8396606 ↗
• InjuryFeb 26, 2019Material Separation; Material Separation

  THE VIPERWIRE WAS INADVERTENTLY ADVANCED INTO A HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL (AT) ARTERY DURING ADVANCEMENT OF A SUPPORT CATHETER. THE VIPERWIRE FRACTURED AND WAS LEFT IN VIVO. ATHERECTOMY WAS PERFORMED IN THE POPLITEAL ARTERY AND WAS FOLLOWED BY BALLOON ANGIOPLASTY FOR POST-DILATION. SLOW FLOW WAS NOTED THROUGH THE AT ARTERY. ATTEMPTS TO REMOVE THE WIRE FRAGMENT WERE UNSUCCESSFUL, AND THE PROCEDURE WAS PROLONGED BY FORTY-FIVE MINUTES. AN ADDITIONAL 45CC OF CONTRAST AND ADDITIONAL FLUOROSCOPY WERE REQUIRED DUE TO THE ATTEMPTS. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS, AND THE PROCEDURE WAS CONCLUDED. REPORTEDLY, THE POPLITEAL TO TIBIOPERONEAL TRUNK WAS SEVERELY CALCIFIED, AS WERE THE ANTERIOR TIBIAL AND POSTERIOR TIBIAL VESSELS.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 8370954 ↗
• InjuryFeb 22, 2019Material Separation; Material Separation

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE, THE VIPERWIRE GUIDE WIRE BECAME DETACHED. FOLLOWING ATHERECTOMY TREATMENT, THE DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) WAS REMOVED FROM THE PATIENT. THE VIPERWIRE WAS NOTED TO HAVE MOVED INTO A CONTRALATERAL VESSEL, AND WHEN THE WIRE WAS RETRACTED IT WAS FOUND TO BE TIGHT WITHIN THE SHEATH. THE WIRE WAS PULLED FIRMLY AND WAS NOTED TO BECOME DETACHED 15 CM ABOVE THE ACCESS SITE. THE BODY OF THE WIRE WAS REMOVED AND THE DETACHED PORTION OF THE WIRE WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8363252 ↗
• InjuryFeb 15, 2019Material Separation; Material Separation

  DURING A PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE VIPERWIRE BROKE. THE TARGET LESION WAS 120 MM LONG AND LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS SEVERELY CALCIFIED, AND THE VESSEL WAS 100% OBSTRUCTED. AFTER TWO PASSES ON LOW SPEED AND THREE PASSES ON MEDIUM SPEED, THE GUIDE WIRE SEEMED TO KINK. AFTER ATHERECTOMY HAD BEEN COMPLETED, THE GUIDE WIRE WAS NOT MOVING INDEPENDENT OF THE OAD. AFTER THE GUIDE WIRE AND OAD WERE REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE SPRING TIP OF THE GUIDE WIRE REMAINED IN THE VESSEL. AN ATTEMPT WAS MADE TO SNARE THE FRAGMENT, AND THE FRAGMENT WAS SEIZED ON THE FIRST TRY AND REMOVED FROM THE PATIENT. FOLLOWING THE FRAGMENT REMOVAL, THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THE RESULT OF THE PROCEDURE WAS GREAT BLOOD FLOW THROUGH THE LESION AND TO THE FOOT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE AND WAS DISCHARGED THE NEXT DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8345287 ↗
• InjuryFeb 11, 2019Material Separation; Material Separation

  DURING A PERIPHERAL PROCEDURE, THE TIP OF THE VIPERWIRE SEPARATED. THE TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS DIFFUSELY DISEASED AND HEAVILY CALCIFIED. WHEN CROSSING THE LESION WITH THE VIPERWIRE, THE TIP OF THE VIPERWIRE SEPARATED. THE VIPERWIRE WAS REMOVED FROM THE PATIENT, AND THE TIP REMAINED IN THE VESSEL. THE VESSEL WAS RE-WIRED, AND TREATMENT WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SUCCESSFULLY PERFORMED IN THE SFA TO JUST PROXIMAL TO THE FRACTURED GUIDE WIRE SPRING TIP. BALLOON ANGIOPLASTY WAS THEN DONE WITH A 5.0MM X 100 BALLOON. DUE TO SHEATH AND GROIN ACCESS ISSUES NOT RELATED TO CSI DEVICES, NO ADDITION TREATMENT WAS DONE, AND THE GUIDE WIRE FRAGMENT REMAINED IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8327393 ↗
• MalfunctionJan 31, 2019Material Separation; Material Separation

  DURING A PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE VIPERWIRE FRACTURED. A 60 CM LONG, 80-85% STENOSED LESION WAS TREATED IN THE DISTAL POPLITEAL ARTERY. AFTER TWO PASSES, THE OAD WAS SPUN TOO CLOSE TO THE TIP OF THE VIPERWIRE, AND THE TIP OF THE VIPERWIRE WRAPPED AROUND THE OAD DRIVESHAFT. AN ATTEMPT TO REMOVE THE WIRE RESULTED IN THE VIPERWIRE FRACTURING AROUND THE OAD. THE OAD AND VIPERWIRE WERE REMOVED TOGETHER FROM THE PATIENT WITH NO ADDITIONAL INTERVENTION, AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY, AND THE PATIENT'S STATUS WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8293856 ↗
• InjuryJan 29, 2019Material Separation; Material Separation

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI VIPERWIRE GUIDE WIRE, THE TIP OF THE WIRE BECAME DETACHED AND REMAINED IN THE PATIENT. THE TARGET LESION WAS 60% STENOSED AND LOCATED IN THE MID-POPLITEAL ARTERY. A PRIMARY WIRE WAS USED TO CROSS THE LESION WITH NO ISSUE NOTED AND WAS THEN EXCHANGED FOR THE VIPERWIRE. THE VIPERWIRE WAS ADVANCED INTO THE PERONEAL ARTERY AND CROSSED THE LESION. WHEN THE WIRE WAS ADJUSTED, THE TIP WAS NOTED TO BE DETACHED. AN ATTEMPT WAS MADE TO SNARE THE WIRE FRAGMENT; HOWEVER, IT WAS UNSUCCESSFUL. BALLOON ANGIOPLASTY WAS PERFORMED TO SECURE THE WIRE FRAGMENT AGAINST THE VESSEL WALL AND THE FRAGMENT REMAINED IN THE PATIENT. THE WIRE WAS REPLACED AND THE LESION WAS THEN TREATED WITH ATHERECTOMY AND ADDITIONAL BALLOON ANGIOPLASTY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8285596 ↗
• InjuryJan 24, 2019Material Separation; Material Separation

  THE TIP OF THE VIPERWIRE FRACTURED IN THE POSTERIOR TIBIAL ARTERY DURING THE PROCEDURE BECAUSE THE ORBITAL ATHERECTOMY DEVICE WAS SPUN OVER THE DISTAL TIP OF THE WIRE. THE FRAGMENT COULD NOT BE RETRIEVED AND WAS LEFT IN VIVO. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8276134 ↗
• InjuryJan 18, 2019Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), A PERFORATION OF THE LEFT ANTERIOR TIBIAL ARTERY OCCURRED. LESIONS IN THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY WERE SUCCESSFULLY TREATED WITH ORBITAL ATHERECTOMY AND BALLOON ANGIOPLASTY. AT THE END OF THE PROCEDURE, A PERFORATION WAS NOTED IN THE LEFT ANTERIOR TIBIAL ARTERY, AND A BLOOD PRESSURE CUFF WAS APPLIED TO THE AREA. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE PHYSICIAN ATTRIBUTED THE PERFORATION TO USER ERROR WHEN ADVANCING THE BALLOON OVER THE GUIDE WIRE RESULTING IN THE GUIDE WIRE ADVANCING INTO A SMALL SIDE BRANCH AND NOT A DEVICE MALFUNCTION.

  Patient problems: Perforation of Vessels

  MAUDE report 8261481 ↗
• InjuryJan 4, 2019Material Separation; Material Separation

  THE TIP OF THE VIPERWIRE FRACTURED DURING ADVANCEMENT AND POSITIONING OF THE WIRE IN A HIGHLY CALCIFIED PORTION OF THE LESION. THE FRAGMENT WAS SNARED AND NO PORTION OF THE WIRE WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED VIA BALLOON ANGIOPLASTY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8216931 ↗
• InjuryDec 31, 2018Material Separation; Material Separation

  THE VIPERWIRE FRACTURED DURING TREATMENT IN THE SUPERIOR FEMORAL ARTERY (SFA), WHICH WAS SEVERELY CALCIFIED AND 90% STENOTIC. AN ATTEMPT WAS MADE TO ADVANCE AN ANGIOPLASTY BALLOON INTO THE SFA TO CONTINUE THE PROCEDURE, BUT THE BALLOON COULD NOT BE ADVANCED THROUGH THE INTRODUCER SHEATH. A DISSECTION OCCURRED DURING THE ATTEMPT TO ADVANCE THE BALLOON. A STENT WAS DEPLOYED TO TREAT THE DISSECTION. ONE FRAGMENT OF THE WIRE WAS FOUND TO BE STUCK IN THE INTRODUCER SHEATH AND WAS REMOVED. ANOTHER FRAGMENT WAS LEFT IN VIVO.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 8206128 ↗
• InjuryDec 31, 2018Material Separation; Noise, Audible; Material Separation; Noise, Audible

  THE VIPERWIRE FRACTURED FOLLOWING AN UNUSUAL AUDIBLE NOISE HEARD DURING THE PROCEDURE IN THE SUPERIOR FEMORAL ARTERY, WHICH WAS 40-70% STENOSED. THE WIRE FRAGMENT WAS LOCATED IN THE EXTERNAL ILLIAC ARTERY, BUT ATTEMPTS TO REMOVE THE FRAGMENT OVER THE NEXT TWO HOURS WERE UNSUCCESSFUL. A HEMATOMA FORMED AT THE ACCESS SITE. ANTICOAGULANTS WERE ADMINISTERED TO THE PATIENT AND THE FRAGMENT WAS THEN SURGICALLY REMOVED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8206073 ↗
• InjuryDec 28, 2018Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE GUIDE WIRE BECAME DETACHED AND REMAINED IN THE PATIENT. THE TARGET LESION WAS A MODERATELY CALCIFIED 90% STENOSED LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AFTER THE LESION WAS TREATED, A STENT WAS PLACED. DURING DEPLOYMENT OF THE STENT AND REMOVAL OF THE GUIDE WIRE, THE DEPLOYMENT SYSTEM OF THE STENT JUMPED FORWARD SLIGHTLY, THE STENT PROLAPSED, AND THE TIP OF THE GUIDE WIRE WAS TRAPPED AND BROKE OFF BEHIND THE STENT. AN ATTEMPT WAS MADE TO CROSS THE PROLAPSED STENT TO PLACE A COVERED STENT, HOWEVER, ONLY A WIRE WAS ABLE TO TRANSVERSE THE PROLAPSED STENT. THE GUIDE WIRE FRAGMENT WAS UNABLE TO BE REMOVED AND REMAINED IN THE PATIENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS SENT TO RECOVERY.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8202446 ↗
• InjuryDec 26, 2018Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DIFFICULTY WAS ENCOUNTERED DURING ADVANCEMENT OF THE VIPERWIRE INTO THE DISTAL ANTERIOR TIBIAL ARTERY. THE VESSEL EXHIBITED 100% STENOSIS, AND THE LESION OF INTEREST WAS TYPE B. SEVEN TREATMENTS WERE COMPLETED WITH THE ORBITAL ATHERECTOMY DEVICE (OAD). DURING THE LAST TREATMENT, THE OAD BECAME STUCK BUT WAS EVENTUALLY RETRACTED. DIFFICULTY WAS ENCOUNTERED DURING REMOVAL OF THE VIPERWIRE SINCE IT WAS STUCK IN A CALCIFIED REGION OF THE VESSEL. DURING ATTEMPTS TO REMOVE THE WIRE, IT FRACTURED. THE INTACT PORTION OF THE WIRE WAS REMOVED, THE VESSEL WAS RE-WIRED, AND THE PROCEDURE WAS CONTINUED. THE FRAGMENT WAS LEFT IN VIVO, AND A STENT WAS USED TO FIX THE FRAGMENT TO THE VESSEL WALL. THE PROCEDURE CONCLUDED WITH GOOD RESULTS AND THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8195960 ↗
• InjuryDec 7, 2018Material Separation; Material Separation

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE VIPERWIRE GUIDE WIRE BECAME DETACHED AND REMAINED IN THE PATIENT. THE TARGET LESION WAS A TOTAL OCCLUSION AND WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL ARTERY (AT). THE TIP OF THE WIRE BECAME DETACHED DURING THE PROCEDURE AND WAS LEFT IN THE PATIENT. THERE WERE NO ADDITIONAL ADVERSE EVENTS REPORTED AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8143003 ↗
• InjuryNov 19, 2018Material Separation; Material Separation

  DURING PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI VIPERWIRE GUIDE WIRE, THE TIP OF THE GUIDE WIRE BECAME DETACHED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY. WHILE RETRACTING THE GUIDE WIRE INTO A BALLOON, THE WIRE CAME INTO CONTACT WITH THE EDGE OF THE BALLOON AND THE TIP OF THE WIRE BECAME DETACHED. THE WIRE FRAGMENT WAS RETRIEVED USING A SNARE AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8086268 ↗
• InjuryNov 7, 2018Material Separation; Material Separation

  UPON REMOVAL OF THE ANGIOPLASTY BALLOON FOLLOWING TREATMENT WITH AN ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS DISCOVERED THAT THE VIPERWIRE HAD FRACTURED IN MORE THAN ONE PLACE. ONE FRAGMENT REMAINED IN THE ANTERIOR TIBIAL ARTERY AND TWO OTHERS REMAINED IN THE DORSALIS PEDIS ARTERY. THE FRAGMENTS WERE REMOVED WITH A COMBINATION OF BALLOON AND FILTER BASKET TECHNIQUES FOLLOWING UNSUCCESSFUL USE OF A SNARE. THE PATIENT WAS DISCHARGED HOME WITHOUT COMPLICATION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8046185 ↗
• MalfunctionOct 24, 2018Material Separation; Material Separation

  SIX TREATMENTS WITH THE ORBITAL ATHERECTOMY DEVICE WERE PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY FOLLOWING FAILED DELIVERY OF THE VIPERWIRE TO THE TIBIAL ARTERY AFTER SEVERAL ATTEMPTS. DURING THE ATTEMPTS TO DELIVER THE WIRE TO THE TIBIAL ARTERY, THE WIRE HAD FOLDED SEVERAL TIMES. THE TIP OF THE WIRE BROKE OFF IN SITU NEAR THE AORTIC BIFURCATION DURING RETRACTION, AND A SNARE WAS USED TO REMOVE THE FRAGMENT. THE PATIENT WAS DISCHARGED AS PLANNED FOLLOWING THE PROCEDURE. APPROACH FOR THE PROCEDURE WAS CONTRALATERAL, AND THE VESSEL WAS 80% STENOTIC WITH A TYPE B LESION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7998775 ↗