ViperWire GWC-12325LG-FLPRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10852528005183), received between Sep 28, 2015 and Sep 2, 2026 — classified as 2 deaths, 52 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (43 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 57 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Material Separation

  Patient problems: Foreign Body In Patient

  MAUDE report 50573522 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, NON-TORTUOUS, 85% STENOSED PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH DIAMONDBACK 360 PRECISION ORBITAL ATHERECTOMY DEVICE (OAD). THE LESION WAS PRIMARY WIRED WITH VIPERWIRE ADVANCE CORONARY GUIDE WIRE (FLOPPY) THROUGH RIGHT FEMORAL ARTERY ACCESS. FROM ANGIOGRAM IT APPEARED THE VIPERWIRE WAS IN TRUE LUMEN, SITTING IN MID TO DISTAL RCA, STRAIGHT AND NOT IN A BRANCH. NO VESSEL PREPARATION WAS PERFORMED. SEVERAL LOW-SPEED OAD TREATMENTS WERE PERFORMED FOLLOWED BY 2 HIGH-SPEED TREATMENTS. AFTER OAD REMOVAL, ANGIOGRAPHIC IMAGES SHOWED NO REFLOW IN THE TREATED RCA. THE PATIENT BECAME APNEIC (SHORT OF BREATH) AND BLOOD PRESSURE DROPPED TO LOW (HYPOTENSION). CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY MEDICATIONS WERE ADMINISTERED INCLUDING ATROPINE, BUT PATIENT DID NOT RESPOND. ECHO CARDIOGRAM WAS TAKEN BUT NO PERFORATION WAS OBSERVED. THE PATIENT EXPIRED AFTER 45 MINUTES OF UNSUCCESSFUL RESUSCITATION EFFORTS. THE PHYSICIAN THINKS THE PATIENT¿S DISEASE CONTRIBUTED TO THE EVENT AND THERE WAS SOMETHING ELSE GOING ON WITH PATIENT¿S STABILITY AND SICKNESS MAKING THE PATIENT UNABLE TO TOLERATE THE TREATMENT. IN THE OPINION

  Patient problems: Cardiac Arrest; Dyspnea; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 24728563 ↗
• DeathAug 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) LESION, A DIAMONDBACK 360 CORONARY PRECISION ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO PERFORM FIRST TREATMENT ON LOW SPEED BACK AND FORTH A FEW TIMES. THE PHYSICIAN LET THE HEART REPERFUSE FOR FEW SECONDS AND THEN SECOND TREATMENT WAS PERFORMED ON HIGH SPEED AND WHEN THE PHYSICIAN REACHED THE LESION, THE CROWN JUMPED FORWARD. THE OAD WAS TURNED OFF AND REMOVED. A CONTRAST WAS USED AND PERFORATION WAS NOTED. THE VIPERWIRE CORONARY GUIDEWIRE WAS PULLED BACK AND THE DISTAL TIP COULD NOT MOVE AS THE GUIDEWIRE WAS SHEARED OFF. THE VIPERWIRE GUIDEWIRE WAS EXCHANGED FOR ANOTHER WIRE AND A BALLOON WAS INFLATED TO STOP BLEEDING. PERICARDIOCENTESIS WAS PERFORMED. COMPRESSIONS WERE PERFORMED AND AFTER THE PATIENT WAS CODED FOR 45 MINUTES, THE PATIENT EXPIRED.

  Patient problems: Perforation of Vessels

  MAUDE report 22816117 ↗
• InjuryAug 7, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT A NON-ABBOTT GUIDEWIRE WAS USED TO WIRE THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A TELEPORT CATHETER WAS INSERTED TO EXCHANGE FOR A VIPERWIRE CORONARY GUIDEWIRE AND A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO THE LESION. THE TIP OF THE SHAFT WAS ADVANCED JUST BEFORE THE LESION. THREE TREATMENTS WERE PERFORMED ON LOW SPEED WERE PERFORMED TO TREAT THE LESION. DURING REMOVAL OF THE OAD, GLIDE ASSIST WAS ACTIVATED AND THE DEVICE GOT STUCK IN THE MID-SHAFT OF THE LEFT MAIN (LM). A ¿REVVING SOUND¿ WAS NOTED AS THE GLIDE ASSIST WAS FAILING AND SEVERAL ATTEMPTS WERE MADE TO RE-ENGAGE GLIDE ASSIST BUT IT COULD NOT STAY ON. THE CONVENTIONAL REMOVAL METHOD FAILED AS THE OAD AND GUIDEWIRE COULD NOT MOVE. THE SHAFT AND THE GUIDEWIRE WERE CUT SO THAT A GUIDELINER COULD BE ADVANCED IN AN ATTEMPT TO WRAP THE CROWN AND REMOVE THE DEVICE. THE CROWN AND SHAFT WERE SUCCESSFULLY REMOVED BUT THE TIP OF THE VIPERWIRE GUIDEWIRE DISLODGED AND REMAINED IN THE LAD RESULTING IN A DISSECTION. ATTEMPTS WERE MADE TO INFLATE A BALLOON AND TRAP THE TIP WITH THE HELP OF A GUIDEWIRE BUT WAS UNSUCCESSFUL. A BALLOON WAS USED THE DISSECTED LAD WAS STENTED TRAPPING THE

  Patient problems: Vascular Dissection

  MAUDE report 22742604 ↗
• InjuryJul 2, 2025Off-Label Use; Material Separation; Device Damaged by Another Device; Off-Label Use; Material Separation; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A CALCIFIED LATERAL OBTUSE MARGINAL ARTERY, PROXIMAL TO STENT, THE VESSEL WAS PRIMARILY WIRED WITH A VIPERWIRE ADVANCE CORONARY GUIDEWIRE AS A BUDDY WIRE OVER A PRIOR NON-ABBOTT GUIDEWIRE WHICH WAS LATER REMOVED. THE WIRE TIP SHEARED OFF DURING A LEFT HEART CATHETERIZATION (LHC), DURING REMOVAL AFTER PASSING SLIGHTLY INTO STENT STENOSED AREA. IT WAS NOTED THAT THERE WAS A PRIOR STENT AND ORBITAL ATHERECTOMY INTO THE PROXIMAL PORTION OF PRIOR STENT. THREE TREATMENTS AT LOW-SPEED AND TWO TREATMENTS AT HIGH SPEED WERE PERFORMED. IT WAS PRESUMED THAT AS ATHERECTOMY WAS PERFORMED INTO THE STENT, THE GUIDEWIRE COULD HAVE BEEN COMPRESSED BETWEEN THE PRIOR STENT STRUT AND THE OAD. THE SPRING TIP OF THE GUIDEWIRE WAS LEFT IN-VIVO IN LATERAL OBTUSE MARGINAL (OM) WHICH WAS A SMALL BRANCH. THE TIP OF THE WIRE WAS TACKED WITH A NEW STENT PROXIMAL TO PREVIOUS STENT. THE STENT WAS PLACED PAST OM, IN OM3 AND ACROSS IT WITH THREE TOTAL STENT WITH VISUALIZATION THAT IT WAS OUTSIDE THE STENT STRUTS. THE PATIENT WAS MONITORED OVERNIGHT AND DISCHARGED THE NEXT DAY. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22385090 ↗
• InjuryMay 2, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, WHILE PLACING THE VIPERWIRE CORONARY GUIDEWIRE IN THE PATIENT, THE GUIDEWIRE ENTERED THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WHERE IT BECAME LODGED IN THE NODULAR CALCIUM, RESULTING IN SPRING TIP FRACTURE. THE ENTIRE RADIOPAQUE TIP OF THE GUIDEWIRE WAS LEFT IN THE PATIENT. THE FRACTURED COMPONENT WAS ENTRAPPED WITH A NON-ABBOTT STENT. MEDICATION WAS ADMINISTERED TO TREAT ISSUE WITH THE DEVICE. THE VESSEL WAS PRIMARILY WIRED WITH THE VIPERWIRE AND NO WIRE BIAS WAS REPORTED. IT WAS NOTED THAT THE ORBITAL ATHERECTOMY DEVICE WAS NOT INSERTED INTO THE PATIENT. THE PATIENT WAS STABLE. THE PHYSICIAN HAD NO CONCERNS ABOUT LONG TERM PATIENT RISK OUTCOMES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21950582 ↗
• InjuryDec 13, 2024Unintended System Motion; Material Separation; Unintended System Motion; Material Separation

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND .012-INCH VIPERWIRE ADVANCE CORONARY GUIDE WIRE WERE USED FOR TREATMENT OF HIGHLY CALCIFIED, 80% STENOSED, 3.5MM-DIAMETER, NON-TORTUOUS LESION IN MID LEFT ANTERIOR DESCENDING ARTERY (LAD) VIA RIGHT RADIAL ACCESS. THE VESSEL WAS PRIMARY WIRED WITH ABBOTT WHISPER GUIDE WIRE WHICH WAS THEN EXCHANGED WITH A VIPERWIRE. ONLY TWO TREATMENTS WERE PERFORMED. DURING THE INITIAL TREATMENT, THE OAD AND THE VIPERWIRE JUMPED FORWARD TOGETHER. THE PHYSICIAN BELIEVES THE JUMP DID NOT CAUSE OAD TIP CONTACT WITH THE VIPERWIRE SPRING TIP. AS THE PHYSICIAN COULD NOT TELL IF THE TIP OF THE VIPERWIRE WAS CONNECTED, A SECOND TREATMENT WAS PERFORMED. THE OAD WAS REMOVED. A NON-ABBOTT MICRO-GUIDE CATHETER WIRE WAS INSERTED OVER THE VIPERWIRE TO EXCHANGE THE VIPERWIRE FOR THE PREVIOUSLY USED WHISPER WIRE. THE VIPERWIRE WAS REMOVED. EX VIVO, IT WAS OBSERVED THE WHOLE VIPERWIRE TIP FROM THE WELD WAS MISSING. THERE WAS NO INDICATION AS TO WHY THE VIPERWIRE FRACTURED AS IT WAS ADVANCED SMOOTHLY IN THE MAIN VESSEL (LAD), THERE WAS NO WIRE BIAS, AND THERE WAS NO KINK IN THE VIPERWIRE PRIOR TO ENTERING THE PATIENT. ADDIT

  Patient problems: Foreign Body In Patient

  MAUDE report 20929305 ↗
• InjurySep 30, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  THE TREATMENT AREA WAS A HEAVILY CALCIFIED CIRCUMFLEX ARTERY. AFTER PLACEMENT OF A NON-ABBOTT CATHETER, THE CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE CORONARY ADVANCE GUIDE WIRE WERE ADVANCED DISTALLY. DURING THERAPY, THE TIP OF THE DRIVESHAFT WAS ADVANCED WITHIN THE 5MM MINIMUM AND THIS WAS DIFFICULT TO VISUALIZE DUE TO THE PATIENT'S BODY HABITUS. IMAGING RESULTS SHOWED THAT THE OAD APPEARED TO BE CLOSE TO THE GUIDEWIRE. THE IMAGING WAS POOR DUE TO THE SIZE OF THE PATIENT. THE PHYSICIAN WAS ADVISED TO ADVANCE THE VIPERWIRE GUIDE WIRE AWAY FROM THE OAD TIP. FOUR LOW SPEED TREATMENTS WERE PERFORMED. FLUOROSCOPY IMAGING WAS CHECKED BUT DUE TO THE ANATOMY OF THE PATIENT, THE IMAGING WAS NOT CLEAR, HOWEVER, A GUIDEWIRE FRACTURE WAS OBSERVED. THE FRACTURED COMPONENT WAS IN THE SIDE BRANCH OF THE MARGINAL ARTERY AND ABOUT 2.5 CM IN LENGTH WHICH WAS LEFT IN-VIVO. THE PHYSICIAN DID NOT HAVE ANY CONCERNS FOR THE LONG-TERM EFFECTS TO THE PATIENT. A TELEPORT GUIDE CATHETER WAS ADVANCED, AND A WIRE EXCHANGE WAS PERFORMED FOR A NON-ABBOTT WIRE. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20333841 ↗
• InjuryAug 10, 2020Material Separation; Material Separation

  A VIPERWIRE GUIDE WIRE WAS SELECTED FOR USE DURING TREATMENT OF TWO HEAVILY CALCIFIED LESIONS IN THE LEFT CIRCUMFLEX ARTERY. THE LESIONS WERE SEPARATED BY AN S-CURVE SEGMENT. TREATMENT OF THE FIRST LESION WAS SUCCESSFULLY PERFORMED. DURING TREATMENT OF THE SECOND LESION, THE OAD NOSE LENGTH FRACTURED. DURING ATTEMPTS TO REMOVE THE FRAGMENT, THE VIPERWIRE WAS PULLED BACK WITH THE FRAGMENT ENGAGED AT THE END OF THE WIRE. THE WIRE FRACTURED. A 3CM SEGMENT OF THE WIRE WAS ABANDONED IN VIVO. AN IMPELLA DEVICE WAS PLACED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. AS OF (B)(6) 2020 THE PATIENT WAS IN STABLE CONDITION. AS OF (B)(6) 2020 THERE IS NO PLAN TO REMOVE THE FRAGMENTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10389096 ↗
• InjuryJul 27, 2020Material Separation; Material Separation

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE WERE SELECTED FOR TREATMENT OF A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE LESION WAS HEAVILY CALCIFIED WITH 90% STENOSIS. THE LAD WAS 3.0 MILLIMETERS IN DIAMETER. THE LESION WAS WIRED, AND THE VIPERWIRE WAS ADVANCED UNTIL IT WOULD NO LONGER ADVANCE. THE LESION WAS TREATED WITH THE OAD IN A PROXIMAL TO DISTAL DIRECTION. THE OAD JUMPED FORWARD ON THE THIRD TREATMENT PASS, AND HALF OF THE SPRING TIP OF THE VIPERWIRE FRACTURED. NO SNARE ATTEMPTS WERE PERFORMED, AND THE PHYSICIAN STENTED THE FRAGMENT TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10325724 ↗
• InjuryJul 6, 2020Material Separation; Material Separation

  DURING A PROCEDURE, THE SPRING TIP OF THE CORONARY VIPERWIRE GUIDE WIRE DETACHED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD), IN AN AREA OF THE VESSEL THAT WAS 3MM IN DIAMETER. THREE TREATMENT PASSES WERE PERFORMED WITH THE CSI ORBITAL ATHERECTOMY DEVICE (OAD). IT WAS NOTED THAT THE TIP BUSHING OF THE OAD DID NOT COME NEAR THE SPRING TIP OF THE GUIDE WIRE DURING TREATMENT. THE VIPERWIRE GUIDE WIRE SEPARATED WHEN THE WIRE WAS BEING REMOVED FROM THE PATIENT. THE FRAGMENT PASSED THROUGH THE AORTA AND DOWN INTO THE ILIAC ARTERY IN THE LEG. THE FRAGMENT WAS RETRIEVED VIA SNARE, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS FINE FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10233770 ↗
• InjuryJun 25, 2020Material Separation; Material Separation

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO SUCCESSFULLY TREAT A LESION LOCATED ON THE MID-DISTAL SECTION OF THE CIRCUMFLEX ARTERY. THE OAD WAS REMOVED, AND THE VIPERWIRE GUIDE WIRE WAS LEFT IN VIVO FOR STENT PLACEMENT. FOLLOWING STENT PLACEMENT, A BALLOON WAS INSERTED, AND WAS UNABLE TO TRACK OVER THE WIRE. IMAGING REVEALED THAT THE WIRE WAS NO LONGER IN THE VESSEL, AND WHEN THE WIRE WAS PULLED BACKWARD THE SPRING TIP OF THE GUIDE WIRE REMAINED IN PLACE. MULTIPLE UNSUCCESSFUL ATTEMPTS WITH ANGIOPLASTY BALLOONS AND A NON-CSI GUIDE CATHETER WERE MADE TO RETRIEVE THE FRAGMENT. THREE GUIDE WIRES WERE THEN INSERTED TO SURROUND THE FRAGMENT, AND IT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT'S BODY. THE PATIENT WAS DISCHARGED AND DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10196892 ↗
• InjuryApr 7, 2020Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  DURING ATTEMPTED EXCHANGE FOLLOWING ATHERECTOMY, THE VIPERWIRE COULD NOT BE REMOVED THROUGH AN EXCHANGE CATHETER DUE TO DAMAGE ON THE SPRING TIP. MULTIPLE CATHETERS WERE PLACED TO ATTEMPT TO REMOVE THE WIRE, BUT IT COULD NOT BE REMOVED VIA THIS METHOD. A SECOND WIRE WAS INSERTED TO KEEP PLACEMENT, AND THE VIPERWIRE WIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH PLANNED STENT PLACEMENT. THE PATIENT WAS STABLE. THE PHYSICIAN'S OPINION WAS THAT THE VIPERWIRE MAY HAVE COME INTO CONTACT WITH THE EDGE OF A STENT CATHETER DURING USE, AND THE SPRING TIP OF THE WIRE MAY HAVE BECOME MISSHAPEN AT THAT TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9932702 ↗
• InjuryFeb 7, 2020Material Separation; Material Separation

  DURING A PROCEDURE, A VIPERWIRE WAS SELECTED FOR USE IN A TIGHTLY STENOSED LESION IN THE MID-RIGHT CORONARY ARTERY (RCA). A COUPLE OF ATHERECTOMY TREATMENT PASSES WERE PERFORMED ON LOW SPEED IN THE PROXIMAL RCA. DURING THE FIRST PASS THROUGH THE MIDSECTION OF THE RCA IN A PROXIMAL-TO-DISTAL DIRECTION, THE CROWN OF THE ORBITAL ATHERECTOMY DEVICE (OAD) JUMPED THROUGH THE LESION AND BECAME STUCK. ATTEMPTS TO REMOVE THE OAD WERE UNSUCCESSFUL. THE PHYSICIAN TRIED TO ADVANCE A NON-CSI GUIDE WIRE THROUGH THE LESION, BUT IT WAS UNABLE TO CROSS. THE OAD WAS THEN CUT AT THE STRAIN RELIEF, AND A GUIDELINER WAS ADVANCED OVER THE DRIVESHAFT IN AN ATTEMPT TO LOOSEN THE OAD; HOWEVER, THIS WAS UNSUCCESSFUL. THE OAD WAS THEN PULLED ON WITH CONSIDERABLE FORCE, AND THE TIP OF THE WIRE BROKE OFF AND REMAINED IN THE RCA. THE PATIENT CODED AND WAS RESUSCITATED. THE PATIENT WAS INTUBATED AND ADMITTED TO THE ICU. THE MID-TO-DISTAL RCA WAS COMPLETELY SHUT DOWN, AND THE PATIENT WAS EXPERIENCING A CONTROLLED MYOCARDIAL INFARCTION. THE PATIENT WAS ASSESSED FOR SURGERY BY A SURGEON BUT WAS TURNED DOWN DUE TO PATIENT STATUS. AS OF (B)(6) 2020, THERE WAS NO LONG-TERM CARE PLAN FOR THE PATIENT. THE SITE DECLINED

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9682350 ↗
• InjuryDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED TO CSI VIA MEDWATCH MW5090736 THAT A CSI ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE GUIDE WIRE WERE USED TO TREAT TWO SEVERELY CALCIFIED TARGET LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA) AND THE BIFURCATION OF THE POSTERIOR DESCENDING ARTERY (PDA). DURING TREATMENT, THE LESION IN THE RCA WAS SUCCESSFULLY TREATED. SUBSEQUENTLY, THE LESION IN THE PDA WAS TREATED WITH MULTIPLE TREATMENT PASSES. THE OAD CAME TOO CLOSE TO THE TIP OF THE GUIDE WIRE, AND THE SPRING TIP OF THE GUIDE WIRE BROKE OFF. THE APPROXIMATELY 5 MILLIMETER GUIDE WIRE FRAGMENT WAS REMOVED WITH THE USE OF A SNARE, AND NO FRAGMENTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. IT WAS REPORTED THAT NO INJURY WAS SUSTAINED BY THE PATIENT. THE OPINION OF THE PHYSICIAN WAS THAT THE FRACTURED WAS CAUSED BY USER ERROR. RE-TRAINING OF SITE STAFF WAS PERFORMED FOR RE-ADJUSTING THE WIRE WHEN GLIDEASSIST MODE WAS UTILIZED DURING A PROCEDURE AND REGARDING KEEPING THE SAFE, RECOMMENDED DISTANCE BETWEEN THE GUIDE WIRE SPRING TIP AND OAD TIP BUSHING.

  Patient problems: Foreign Body In Patient

  MAUDE report 9443488 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CORONARY VIPERWIRE GUIDE WIRE WAS USED TO CROSS TWO 95% STENOSED LESIONS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), FOLLOWING WHICH SLOW FLOW WAS NOTED. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS THEN INSERTED AND OPERATED BRIEFLY, HOWEVER THE PATIENT DESTABILIZED BEFORE THE DEVICE COULD CROSS THE LESION AND THE DEVICE WAS REMOVED. PHARMACOLOGICAL INTERVENTION WAS PERFORMED TO ADDRESS THE SEVERE HEMODYNAMIC CHANGES AND AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A BALLOON, HOWEVER THIS WAS NOT POSSIBLE DUE TO A LACK OF WIRE SUPPORT. CARDIOPULMONARY RESUSCITATION AND DEFIBRILLATION WERE PERFORMED PER HOSPITAL PROTOCOL AND A VENTRICULAR ASSIST DEVICE WAS SUCCESSFULLY DEPLOYED. A TEMPORARY PACEMAKER WAS INSERTED, THE LESIONS WERE CROSSED WITH A NON-CSI WIRE AND CASCADING BALLOON INFLATIONS WERE PERFORMED SUCCESSFULLY. MULTIPLE STENTS WERE PLACED ACROSS THE LESIONS AND REVASCULARIZATION WAS ACHIEVED. THE PATIENT WAS SEVERELY COMPROMISED AFTER THE PROCEDURE DUE TO THE SEVERE INFARCT CAUSED BY THE ABRUPT VESSEL CLOSURE. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE AND EXPIRED THE SAME DAY. PER THE OPINION OF THE PHYSICIAN, THE VIPERWIRE GUIDE WIRE CONTRIBU

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 9356146 ↗
• MalfunctionSep 16, 2019Material Separation; Material Separation

  DURING A PROCEDURE WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS NOTED THE IMAGING WAS NOT VERY GOOD, AND THE OAD WAS SPUN TOO FAR DOWN ON THE GUIDE WIRE ON THE SECOND TREATMENT PASS. THE OAD SEEMED TO CHANGE IN PITCH, AND AN ATTEMPT WAS MADE TO REMOVE THE OAD. THE OAD WAS STUCK ON THE GUIDE WIRE, AND THE OAD AND GUIDE WIRE WERE REMOVED TOGETHER. AFTER THE DEVICES WERE REMOVED, IT LOOKED LIKE THE GUIDE WIRE WAS UNRAVELING. IT WAS CONFIRMED THAT THERE WERE NO BREAKS OR FRACTURES SEEN ON THE GUIDE WIRE AND NO PORTIONS WERE LEFT IN THE PATIENT. THE PHYSICIAN'S OPINION WAS THAT THE GUIDE WIRE UNRAVELED DUE TO THE OAD SPINNING TOO FAR DOWN THE GUIDE WIRE. THE VESSEL WAS RE-WIRED, AND THE PROCEDURE WAS COMPLETED WITH STENTING THE VESSEL. IT WAS NOTED THE PATIENT WAS FINE FOLLOWING THE PROCEDURE. THE VIPERWIRE GUIDE WIRE WAS RECEIVED BY ANALYSIS AND WAS FOUND TO HAVE A FRACTURED SPRING TIP. THE FACILITY WAS UNAWARE OF THE FRACTURED SPRING TIP.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9069672 ↗
• MalfunctionSep 3, 2019Break; Device Dislodged or Dislocated

  DURING CASE WITH ATTEMPTED CSI USE THE LESION WAS CROSSED WITH THE WIRE BUT THE DEVICE WOULD NOT CROSS. DURING HYPERGLIDE WHILE THE DEVICE WAS BEING REMOVED, THE DISTAL PORTION OF THE WIRE BROKE AND DISLODGED IN THE LAD. MANUFACTURER RESPONSE FOR VIPER WIRE, VIPERWIRE ADVANCE CORONARY (PER SITE REPORTER). UNKNOWN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955120 ↗
• InjuryAug 23, 2019Material Separation; Material Separation

  DURING THE PROCEDURE, A 24MM SEGMENT OF THE VIPERWIRE GUIDE WIRE FRACTURED IN A MILDLY-TO-SEVERELY TORTUOUS DISTAL CIRCUMFLEX VESSEL AFTER THE OAD CAME TOO CLOSE TO THE SPRING TIP. THE FRAGMENT WAS LEFT IN VIVO, BUT A PLAN WAS MADE TO ATTEMPT RETRIEVAL IN THE FUTURE. THE PATIENT LATER EXPIRED, AND THE OPINION OF THE PHYSICIAN IS THAT THE DEATH WAS UNRELATED TO A CSI DEVICE SINCE THE VESSEL EXHIBITED GOOD FLOW AFTER TIP DETACHMENT, AND NO DISSECTION OR PERFORATION WAS OBSERVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8926816 ↗
• InjuryAug 22, 2019Material Separation; Material Separation

  THE TIP OF THE VIPERWIRE GUIDE WIRE SHEARED OFF IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) DURING ATHERECTOMY. DUE TO THE SMALL SIZE OF THE VESSEL, THE FRAGMENT COULD NOT BE RECOVERED DESPITE USE OF A SNARE. THE TIP OF THE WIRE WAS LEFT IN VIVO, AND THE PATIENT WAS WELL FOLLOWING THE PROCEDURE. THE CAUSE OF THE WIRE FRACTURE WAS THAT THE OAD WAS OPERATED NEAR THE TIP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8921754 ↗
• InjuryAug 5, 2019Material Separation; Material Separation

  DURING A CORONARY PROCEDURE, THE SPRING TIP OF THE CORONARY VIPERWIRE GUIDE WIRE FRACTURED. A SNARE WAS USED TO REMOVE THE FRACTURED PORTION OF THE GUIDE WIRE. THE PATIENT'S STATUS FOLLOWING THE PROCEDURE WAS GOOD.

  Patient problems: Foreign Body In Patient

  MAUDE report 8860601 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT WITH A VIPERWIRE AND CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) A FLOW-LIMITING DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A DIFFUSELY DISEASED SECTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS STENOSED AT 70% AND WAS APPROXIMATELY 3.00 MM IN DIAMETER, WITH MINIMAL TORTUOSITY IN THE TREATMENT AREA, AND HIGHER TORTUOSITY IN THE DISTAL LAD. THE LESION WAS WIRED VIA THE RADIAL APPROACH, AND THE OAD WAS OPERATED FOR ONE TREATMENT IN THE MID-LAD, WHEN A FLOW-LIMITING DISSECTION WAS NOTED IN THE DISTAL PORTION OF THE LAD, NEAR THE VIPERWIRE. A STENT WAS PLACED TO RESOLVE THE DISSECTION, AND FLOW WAS RESTORED. THE PATIENT WAS DISCHARGED TO THE PROGRESSIVE CARE UNIT (PCU) AND STAYED OVERNIGHT. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 8739815 ↗
• InjuryMay 16, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING ADVANCEMENT OF THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) OVER THE VIPERWIRE CORONARY GUIDE WIRE, THE WIRE WAS NOTED TO MOVE BACKWARDS FROM ITS INITIAL LOCATION AND WOULD NOT ADVANCE FURTHER. PER PHYSICIAN OPINION THE SPACING WAS ADEQUATE, AND ONE TREATMENT PASS WITH THE OAD WAS PERFORMED. FOLLOWING THIS PASS, THE VIPERWIRE BECAME CAUGHT ON THE TIP OF THE OAD AND FRACTURED. THE WIRE FRAGMENT WAS LOCATED IN A SIDE BRANCH, THEREFORE NO ATTEMPT WAS MADE TO SNARE IT AND IT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS REPORTED THAT THE IMAGING SETUP OF THE OPERATING ROOM WAS INADEQUATE AND THAT IT WAS DIFFICULT TO VISUALIZE THE FORWARD MOVEMENT OF THE DEVICE IN THE VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8616269 ↗
• InjuryApr 30, 2019Material Separation; Material Separation

  DURING A PROCEDURE VIPERWIRE GUIDE WIRE WAS USED DURING TREATMENT OF A 95% STENOSED TYPE B LESION IN THE LEFT MAIN CORONARY ARTERY. THE LESION WAS TREATED WITH FIVE PASSES AT 80,000 RPM. ON THE FIFTH TREATMENT PASS, THE TIP OF THE GUIDE WIRE FRACTURED BECAUSE THE CROWN OF THE OAD JUMPED FORWARD. THE PHYSICIAN DECIDED TO ABANDON THE WIRE FRAGMENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8566547 ↗
• InjuryApr 11, 2019Material Separation; Material Separation

  ATHERECTOMY WAS PERFORMED WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE AND VIPERWIRE IN THE CIRCUMFLEX ARTERY, PROXIMAL TO DISTAL. ATHERECTOMY WAS APPLIED IN THE PROXIMAL TO MID SECTION OF THE VESSEL. FOLLOWING THAT, THE VIPERWIRE WAS ADVANCED INTO THE OBTUSE MARGINAL (OM) BRANCH SINCE THE DISTAL LESION WAS NEAR THE BIFURCATION OF THE OM. GLIDEASSIST WAS USED TO ADVANCE THE OAD INTO THE LESION AND A REVERSE SPIN WAS APPLIED FOR TREATMENT. THE OAD WAS 10MM AWAY FROM THE FIRST RADIOPAQUE MARKER OF THE VIPERWIRE. THE OAD WAS REMOVED AND A COMPETITOR WIRE WAS PLACED FOR BALLOON ANGIOPLASTY SUPPORT. ANGIOPLASTY WAS PERFORMED. THE VIPERWIRE WAS THEN REMOVED, BUT THE DISTAL TIP OF THE VIPERWIRE REMAINED IN VIVO. ANOTHER GUIDE WIRE WAS INSERTED ALONGSIDE THE OTHER COMPETITOR WIRE, AND AN ATTEMPT WAS MADE TO REMOVE THE VIPERWIRE TIP. WHILE ATTEMPTING TO REMOVE THE WIRE TIP, THE PROXIMAL PORTION OF THE WIRE BECAME BURIED IN THE SUBINTIMAL SPACE. SINCE THE BURIED WIRE WAS IN THE LOCATION WHERE THE PHYSICIAN WAS PLANNING TO STENT, THE TIP WAS LEFT IN VIVO, AND A STENT WAS PLACED OVER IT. INTRAVENOUS ULTRASOUND WAS USED TO CONFIRM STENT APPOSITION AND TO VISUALIZE THE WIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8505619 ↗