V-14™ Control Wire™ H74939216930010Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729799269), received between Sep 6, 2018 and Nov 20, 2025 — classified as 15 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE WIRE BROKE OFF WITHIN THE ARTERY, REQUIRING ADDITIONAL INTERVENTION. DURING A LOWER EXTREMITY (LE) ANGIOGRAM, THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL (PT) ARTERY. A LONG TAPER 300 CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. WHILE CROSSING THE LESION, THE TIP OF THE GUIDEWIRE FRACTURED AND BROKE OFF WITHIN THE PT ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SEPARATED TIP USING A SNARE DEVICE; HOWEVER, RETRIEVAL EFFORTS WERE UNSUCCESSFUL DUE TO THE SEVERITY OF THE VESSEL CALCIFICATION. THE FRACTURED TIP REMAINED WITHIN THE ARTERY, AND THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE PATIENT CONDITION WAS GOOD FOLLOWING PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23604614 ↗
• InjuryNov 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT TIP BREAK OCCURRED, REQUIRING AN ADDITIONAL DEVICE. A 300CM V-14? CONTROL WIRE? WAS SELECTED FOR USE DURING A BELOW THE KNEE ANGIOPLASTY PROCEDURE. THE TARGET LESION WAS GREATER THAN 90% STENOSED, WAS MODERATELY CALCIFIED AND MILDLY TORTUOUS. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE WHILE REMOVING THE DEVICE FROM THE BODY POST ANGIOPLASTY. IT WAS NOTED THAT THE DEVICE WAS OUTSIDE THE BODY AT THE TIME OF THE FRACTURE, AND IT WAS ALSO NOTED THAT THE DEVICE WAS REMOVED INTACT WITH THE HELP OF A DIAGNOSTIC CATHETER. A NEW V-14 CONTROL WIRE WAS USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ONLY THE TIP OF THE WIRE BROKE. WHEN THE PHYSICIAN RETRACTED THE DAMAGED V-14 WIRE WITH THE HELP OF A CATHETER, SHE WAS ABLE TO VISUALIZE THE EXTENT OF THE DAMAGE. ADVANCING THE BALLOON OVER THE DAMAGED WIRE WAS DIFFICULT AND IT DID NOT PROVIDE ADEQUATE SUPPORT, SO THE WIRE WAS REMOVED AND REPLACED WITH A NEW ONE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENTS BODY WITH THE ASSISTANCE OF A DIAGNOSTIC CATHETER. THE TIP WAS OBSERVED TO BE DETACHED UPON REMOVAL OF THE DIAGNOSTIC CATHETER IN THE STERILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536255 ↗
• MalfunctionOct 2, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HYDROPHILIC COATING WAS MISSING FROM THE GUIDEWIRE. A V-14 CONTROL WIRE WAS SELECTED FOR USE IN BALLOON ANGIOPLASTY PROCEDURE IN THE TIBIAL ARTERY. IT WAS INSERTED THROUGH A MICROPUNCTURE KIT AND NON-BSC SUPPORT CATHETER INTO THE PEDAL ARTERY. WHEN THE V-14 CONTROL WIRE WAS REMOVED, IT WAS OBSERVED THAT THE HYDROPHILIC COATING WAS MISSING FROM THE GUIDEWIRE. SUBSEQUENT FLUOROSCOPIC PICTURES WERE TAKEN, AND IN WHICH NO PART OF THE GUIDEWIRE WAS FOUND (IN-SITU). THE SURGEON WAS NOT CONCERNED, AND NO FURTHER PROCEDURES WILL BE UNDERTAKEN DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23203189 ↗
• MalfunctionAug 29, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT THE DEVICE LOST THE DISTAL TIP COATING. VASCULAR ACCESS WAS GAINED VIA IPSILATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE NEARLY OCCLUDED LEFT PERONEAL ARTERY. A 300CM V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE IN A AN ANGIOPLASTY PROCEDURE. AN ATTEMPT TO CROSS THE LESION WAS MADE; HOWEVER THE GUIDEWIRE FAILED TO CROSS THE LESION. THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. A FLUOROSCOPY IMAGE SHOWED A PIECE OF THE WIRE COATING WAS STILL IN THE PATIENTS VESSEL, ADJACENT TO THE OCCLUSION. IT WAS NOT POSSIBLE TO RETRIEVE THE PIECE OF THE WIRE COATING. THE PHYSICIAN WAS HAPPY TO CONCLUDE THE CASE AT THIS POINT AS THE PIECE OF WIRE DEBRIS COULD NOT MOVE PAST THE OCCLUDED PORTION OF THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS NO ATTEMPT TO REMOVE THE PIECE OF WIRE COATING FROM THE PATIENT AND THERE ARE NO PLANS TO TRY AND RETRIEVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22922569 ↗
• MalfunctionMar 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WIRE TIP BROKE OFF. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND FIBROTIC CALCIFIED VESSEL. A V-14 CONTROL WIRE WAS USED FOR TREATMENT. DURING THE PROCEDURE, WHILE THE DEVICE WAS BEING ADVANCED ACROSS THE LESION, IT WAS OBSERVED THAT THE WIRE TIP FRACTURED. THE DETACHED WIRE TIP WAS LATER FOUND IN THE PATIENT'S LUNG. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21688896 ↗
• MalfunctionMar 14, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE TIP BROKE AND WAS REMOVED. DURING A PROCEDURE USING THIS V-14 CONTROL WIRE, THE TIP OF THE WIRE BROKE IN THE DORSALIS PEDIS ARTERY. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS DEVICE, AND THE BROKEN TIP WAS ABLE TO BE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607691 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY TO REMOVE THE GUIDEWIRE AND TIP STRIPPED OFF. TWO V-14 CONTROL WIRES WERE USED WITH DEVELOPMENT DEVICE FOR A PRE-CLINICAL ANIMAL STUDY. WHEN THE DEVICE WAS WITHDRAWN, SIGNIFICANT RESISTANCE WAS FELT. THE ADDED FORCE AND THE ANGLE OF THE WIRE CAUSED THE GUIDEWIRE LUMEN TO SCRAPE THE POLYMER TIP OFF. ANOTHER OF THE SAME DEVICE WAS USED BUT EXPERIENCED THE SAME PROBLEM. THERE WERE NO COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THIS WAS AN ANIMAL STUDY PROCEDURE BEING PERFORMED AS PART OF THE PRODUCT DEVELOPMENT PROCESS (PDP) EVALUATING GUIDEWIRE TRACKING AND EXCHANGE CAPABILITIES WITH A DEVELOPMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20129083 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DIFFICULTY TO REMOVE THE GUIDEWIRE AND TIP STRIPPED OFF. TWO V-14 CONTROL WIRES WERE USED WITH A DEVELOPMENT DEVICE FOR A PRE-CLINICAL ANIMAL STUDY. WHEN THE DEVICE WAS WITHDRAWN, SIGNIFICANT RESISTANCE WAS FELT. THE ADDED FORCE AND THE ANGLE OF THE WIRE CAUSED THE GUIDEWIRE LUMEN TO SCRAPE THE POLYMER TIP OFF. ANOTHER OF THE SAME DEVICE WAS USED BUT EXPERIENCED THE SAME PROBLEM. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128822 ↗
• MalfunctionApr 9, 2024Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDEWIRE HAD COATING ISSUES. A 300CM V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR PERIPHERAL ANGIOPLASTY. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE GUIDEWIRES FELT NOT RIGID ENOUGH AND HYDROPHILIC COATING WAS LOST DURING NAVIGATION. BY THE TIME THE GUIDEWIRE WAS USED FOR PLATFORMING, THE GUIDEWIRE GOT STUCK WITH A NON-BSC SUPPORT CATHETER. THE GUIDEWIRE AND NON-BSC SUPPORT CATHETER WERE REMOVED TOGETHER, AND NO COATING OR WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074917 ↗
• MalfunctionDec 22, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT PEELED COATING OF THE DEVICE OCCURRED. THE PATIENT UNDERWENT LOWER EXTREMITY ANGIOPLASTY. A 300CM STRAIGHT TIP V-14 SHORT TAPER CONTROL GUIDE WIRE WAS SELECTED FOR USE. UPON INSERTION, THERE WAS AN ODD SENSATION WHEN ADVANCING THROUGH THE SHEATH. THE DEVICE WAS PULLED OUT AND IT WAS NOTED THAT THE COATING CAME OFF OF THE TIP AND THE TIP WAS KINKED. THE DEVICE WAS REMOVED INTACT AND NO REMAINS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383031 ↗
• MalfunctionNov 8, 2023Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE V-14 CONTROL GUIDEWIRE LONG TAPER 300CM STRAIGHT TIP WAS USED FOR DURING TREATMENT OF PERIPHERAL ARTERY DISEASE, HOWEVER, DURING AN ANGIOGRAM THE WIRE COATING PEELED AT THE DISTAL TIP. IT WAS CONFIRMED NO COATING/WIRE FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095049 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS POSTERIOR TIB VESSEL. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, WHILE TRYING TO NAVIGATE THE WIRE INTO THE VESSEL, THE SOFT TIP PART OF THE WIRE PARTIALLY SHEARED OFF. THE PHYSICIAN WAS ABLE TO PLACE A NON-BOSTON SCIENTIFIC CATHETER BEYOND THE SEPARATION AND RETRIEVE THE WIRE WITHOUT LOSING THE WIRE ACCESS TO THE VESSEL AND WITHOUT HARMING THE PATIENT. ALL PARTS OF THE WIRE WERE STILL INTACT; AND WAS CONFIRMED THROUGH FLUOROSCOPY THAT NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558804 ↗
• InjuryMar 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT MW5114671 THAT TIP DETACHMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE TARGET LESION WAS LOCATED IN PROXIMAL POSTERIOR TIBIAL ARTERY. A V-14 LONG TAPER 300CM STRAIGHT TIP CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, DURING PROCEDURE, THE TIP OF THE WIRE FRACTURED NEAR THE PROXIMAL POSTERIOR TIBIAL ARTERY. THE FRACTURED WIRE WAS NOTED TO BE CLINICALLY INCONSEQUENTIAL AND WILL NOT EXPOSE ANY RISK TO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16529740 ↗
• InjuryOct 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL TIP DETACHMENT AND STENT THROMBOSIS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEG. A 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DISTAL TIP OF THE WIRE WAS BROKEN INSIDE THE VESSEL AND THROMBOSIS WAS NOTED. THE DETACHED PORTION WAS REMOVED USING A SNARE AND THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD OR DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15627978 ↗
• InjuryJun 24, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. A 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS USED. HOWEVER, DURING THE PROCEDURE, THE COATING OF THE TIP PEELED OFF AND WAS RETRIEVED BY SNARING. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14804399 ↗
• InjuryMar 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DISTAL TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND MILDLY CALCIFIED LEFT ILIAC ARTERY. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS ADVANCED. HOWEVER, DURING INTRODUCTION, LIGHT RESISTANCE WAS ENCOUNTERED AND THE GUIDEWIRE TIP SHEARED OFF. AN ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENT BY SNARING BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS FINE AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 13967047 ↗
• InjuryFeb 4, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DISTAL TIP FRACTURED AND REMAINED INSIDE THE PATIENT. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATE TO SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM V-14 CONTROL WIRE AND A 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WERE SELECTED FOR A PERIPHERAL REVASCULARIZATION PROCEDURE. THE LESION WAS PREDILATED. DURING THE PROCEDURE, THE DISTAL TIP OF THE V-14 CONTROL WIRE FRACTURED AND REMAINED IN A SUBINTIMAL CHANNEL IN THE SFA. THROUGHOUT THE ENTIRE PROCEDURE, FRICTION OCCURRED IN THE SYSTEMS. DURING DEPLOYMENT, LOTS OF FORCE WAS REQUIRED TO DEPLOY THE STENT. FIFTY PERCENT OF THE STENT WAS DEPLOYED WHEN THE EVENT OCCURRED. PULLING THE PULL GRIP AND PULLING BACK ON THE DELIVERY SYSTEM ULTIMATELY DEPLOYED THE STENT. THE STENT STRETCHED AND FRACTURED. THE STENT WAS NOT REMOVED FROM THE PATIENT AND REMAINED IN THE VESSEL. THE STENT WAS POST DILATED. NO KINKS WERE OBSERVED. THE NON-BOSTON SCIENTIFIC GUIDEWIRE AND THE STENT DELIVERY SYSTEM WERE INTACT AND REMOVED TOGETHER FROM THE PATIENT. A NON-BOSTON SCIENTIFIC .014 GUIDEWIRE WAS USED TO COMPLETE THE PROCEDU

  Patient problems: Foreign Body In Patient

  MAUDE report 13459356 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. DURING A PROCEDURE INVOLVING A LONG TAPER 300CM STRAIGHT TIP V-14 CONTROL WIRE, IT WAS NOTED THAT THE WIRE TIP BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH OTHER PRODUCTS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12806412 ↗
• InjuryOct 20, 2021Detachment of Device or Device Component; Difficult to Advance; Material Twisted/Bent; Detachment of Device or Device Component; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH ATHEROSCLEROTIC DISEASE IN TIBIAL ARTERIES. THE TARGET LESION WAS LOCATED IN THE TIBIAL ARTERY. DURING A RETROGRADE PROCEDURE, A 300CM V-14 CONTROL GUIDEWIRE WAS ADVANCED AND A 018 NON-BOSTON SCIENTIFIC CATHETER WAS USED TO SUPPORT THE WIRE. HOWEVER, THERE WAS LACK OF WIRE TRACTION AND THE WIRE LOOPED. SUBSEQUENTLY, 5MM OF THE GUIDEWIRE TIP DETACHED. SNARING OF THE DETACHED FRAGMENT WAS ATTEMPTED AND FAILED. THE PHYSICIAN THEN USED A BALLOON EXPANDABLE STENT TO JAIL THE TIP OF THE GUIDEWIRE IN THE TIBIAL VESSEL. THE PROCEDURE WAS COMPLETED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12669346 ↗
• InjuryAug 2, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND DISTAL TIP DETACHMENT OCCURRED. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED ANTERIOR TIBIAL ARTERY. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS ADVANCED TO CROSS THE LESION AND A 2X120 COYOTE BALLOON CATHETER WAS USED FOR SUPPORT. HOWEVER, DURING THE PROCEDURE, THE WIRE WOULD NOT ADVANCE FURTHER AND WAS BUCKLED APPROXIMATELY HALF WAY DOWN THE TIBIAL ARTERY. THE PHYSICIAN FELT A LITTLE RESISTANCE UPON PULLING THE WIRE BACK INTO THE CATHETER AND NOTICED THE SMALL BLACK BALL JUST BEYOND THE CATHETER TIP. THE DEVICE WAS COMPLETELY REMOVED AND CONFIRMED THAT THE DISTAL 1CM OF POLYMER WAS STRIPPED OFF OF THE WIRE. NO ATTEMPT WAS MADE TO RETRIEVE THE SMALL PIECE OF POLYMER SINCE IT WAS STUCK IN THE MIDDLE OF A COMPLETED OCCLUDED ARTERY CAUSING NO OBSTRUCTION. THE PHYSICIAN TRIED CROSSING THE CTO AGAIN WITH A .035 NON-BSC WIRE, BUT WAS STILL UNSUCCESSFUL. THEY WERE SATISFIED WITH THE SUCCESSFUL TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY, SO THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12264553 ↗
• MalfunctionAug 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL NEAR THE ANKLE. A 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED BUT IT BECAME FRACTURED, ALTHOUGH STILL CONNECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264031 ↗
• InjuryApr 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHED AND REMAINED IN THE PATIENT. A 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, TIP OF THE WIRE CAME OFF INSIDE THE VESSEL AND THE TIP BECAME LODGED IN THE PLAQUE AND COULD NOT BE RETRIEVED. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9920597 ↗
• InjuryFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS ADVANCED, HOWEVER, THE TIP CAME OFF. NO ATTEMPT TO REMOVE THE DETACHED FRAGMENT AS IT WAS IN THE PLAQUE ALONG THE ARTERY. THE PROCEDURE WAS COMPLETED WITH TWO NON-BSC GUIDEWIRES. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9688109 ↗
• MalfunctionJan 24, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT TIP SEPARATION OCCURRED. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS ADVANCED TO CROSS THE LESION. HOWEVER, AFTER THE WIRE WAS WITHDRAWN FROM THE PATIENT'S BODY, THE TIP OF THE DEVICE WAS FOUND SEPARATED AND WAS VISUALLY DESCRIBE TO BE BRANCH LIKE. SEPARATION WAS OBSERVED BUT THE TIP WAS NOT FULLY DETACHED. THE PROCEDURE WAS COMPLETED. THE PHYSICIAN PUT THE PATIENT UNDER OBSERVATION; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9627919 ↗
• InjuryDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE WIRE DETACHED INSIDE THE PATIENT. A 300CM V-14 CONTROL WIRE WAS SELECTED FOR USE FOR BELOW-THE-KNEE (BTK) PROCEDURE OF THE HEAVILY CALCIFIED LESION. DURING THE PROCEDURE, THE DISTAL END OF THE WIRE TIP DETACHED INSIDE THE PATIENT. THE WIRE FRAGMENT REMAINED IN THE PATIENT'S LEG. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9473710 ↗