V-14™ Control Wire™ H74939216730010Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 08714729799221), received between Sep 5, 2018 and Aug 5, 2026 — classified as 61 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 111 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Detachment of Device or Device Component

  It was reported that the guidewire tip detached. A V-14? Control Wire? Short Taper Straight Tip 300cm guidewire was selected for use in a right leg angioplasty procedure. During the procedure, the proximal half of the guidewire tip broke off inside the patient. The guidewire fragment could not be retrieved. There were no further complications reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50140991 ↗
• MalfunctionApr 3, 2026Entrapment of Device; Fracture; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WIRE BECAME STUCK AND BEGAN TO SEPARATE. A V-14? CONTROL WIRE? WAS SELECTED FOR USE IN THE PLAIN OLD BALLOON ANGIOPLASTY (POBA) PROCEDURE. THE TARGET LESION WAS LOCATED IN THE 90% STENOSED ANTERIOR TIBIAL ARTERY, AND WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. DURING THE PROCEDURE, WHILE CROSSING THE LESION, THE WIRE BECAME STUCK WITHIN THE PATIENT ANATOMY. THE WIRE WAS REMOVED FROM THE PATIENT IN ONE PIECE. UPON REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE WIRE HAD BEGUN TO PEEL. THE WIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778920 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT WIRE DETACHED OCCURRED. THE TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY LESION. A V-14? CONTROL WIRE? GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE WIRE DETACHED. THE WIRE WAS REMOVED AND A NEW WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262099 ↗
• MalfunctionJan 5, 2026Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED TIBIAL ARTERY. A 2.5MM X 60MM X 150CM COYOTE BALLOON CATHETER AND 300CM V-14 CONTROL WIRE GUIDEWIRE WERE SELECTED FOR TIBIAL ANGIOPLASTY. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE AND BALLOON HAD BECOME FUSED DURING THE PROCEDURE, REQUIRING BOTH DEVICES TO BE PULLED AND REMOVED AS A SINGLE UNIT. THE BALLOON WAS REMOVED IN A FULLY DEFLATED STATE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959931 ↗
• InjuryNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT AND VESSEL OCCLUSION OCCURRED, AND THE PROCEDURE WAS CANCELLED. DURING THE INTERVENTION, A V-14 SHORT TAPER 300 CM STRAIGHT TIP WIRE WAS USED IN AN ATTEMPT TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) OF THE ANTERIOR TIBIAL ARTERY. WHILE ADVANCING THROUGH A COLLATERAL VESSEL, THE WIRE TIP FRACTURED AND REMAINED WITHIN THE VESSEL, RESULTING IN PARTIAL OCCLUSION OF THE COLLATERAL. THROMBOSIS WAS ALSO NOTED. AFTER EVALUATION, THE PHYSICIAN ELECTED TO DISCONTINUE ATTEMPTS TO CROSS THE ANTERIOR TIBIAL CTO. THE RETAINED WIRE TIP WAS LEFT IN PLACE, AS IT WAS ASSESSED TO POSE NO SIGNIFICANT CLINICAL RISK. THE ANTERIOR TIBIAL BRANCH REMAINED OCCLUDED, CONSISTENT WITH AN INFLOW/OUTFLOW ISSUE. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED ANTERIOR TIBIAL ARTERY. THE PATIENTS ANATOMY WAS CONSIDERED CHALLENGING, AND PATIENT-RELATED FACTORS CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, NO PROCEDURAL FACTORS WERE IDENTIFIED AS CONTRIBUTING. THE PATIENT REMAINED IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 23659949 ↗
• MalfunctionSep 25, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE TIP BROKE. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ANTERIOR TIBIAL VESSEL. A 300CM STRAIGHT TIP V-14? CONTROL WIRE? WAS SELECTED FOR USE. DURING THE PROCEDURE WHILE CROSSING THE LESION, THE HYDROPHILIC TIP DETACHED AND REMAINED IN A SMALL BRANCH OF THE ANTERIOR TIBIAL VESSEL. THE REST OF THE DEVICE WAS REMOVED FROM THE BODY. THE PHYSICIAN ELECTED TO LEAVE THE TIP IN PLACE, CONSIDERING THE RISK MINIMAL AND THE BRANCH SMALL ENOUGH. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO ADVERSE EFFECTS WERE OBSERVED FROM LEAVING THE TIP BEHIND. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23145193 ↗
• MalfunctionSep 15, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE IN A LOWER EXTREMITY ANGIOGRAM. WHILE CROSSING A STENT IN THE THROMBOSED SFA, THE TIP OF THE V-14 CONTROL WIRE BECAME STUCK IN THE STRUTS OF THE STENT. WHEN ATTEMPTING TO REMOVE THE WIRE, APPROXIMATELY 2CM OF THE TIP OF THE WIRE FRACTURED AND THE FRAGMENT APPEARED TO BE LODGED IN THE STENT BETWEEN THE ARTERIAL WALL AND THE STENT. NO FRAGMENT RETRIEVAL WAS ATTEMPTED FOR THE REMAINDER OF THE CASE AS THE PHYSICIAN DID NOT SEE ANY INHERENT DANGER OF THE WIRE PARTICLE EMBOLIZING DISTALLY AND THERE WAS NO PLAN TO REMOVE THE DETACHED FRAGMENT IN THE NEAR FUTURE. AN ANGIOPLASTY OF THE AREA WHERE THE TIP FRAGMENT WAS LODGED WAS PERFORMED AS PART OF THE STANDARD PROTOCOL TO TREAT THE LESION. THE PROCEDURE WAS COMPLETED WITH THE USE OF OTHER DEVICES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23056562 ↗
• MalfunctionSep 11, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026372 ↗
• MalfunctionSep 10, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COATING WAS PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23018326 ↗
• InjuryAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL ANTERIOR TIBIAL ARTERY. A 300CM V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL TIP OF THE WIRE DETACHED AND ABOUT 1CM LENGTH WAS LEFT BEHIND IN THE PATIENT'S LEFT TIBIAL ARTERY. THE WIRE TIP WAS ATTEMPTED TO SNARE HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22778244 ↗
• InjuryJul 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT REQUIRING ADDITIONAL INTERVENTION. A V-14 CONTROL WIRE WAS ADVANCED. DURING THE PROCEDURE, THE TIP BROKE. AN ATTEMPT WAS MADE TO SNARE IT; HOWEVER, THE TIP REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22637198 ↗
• InjuryJun 2, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THE DEVICE SEPARATED AND DETACHED INSIDE OF THE PATIENT. A V-14 SHORT TAPER 300CM STRAIGHT TIP CONTROL WIRE WAS SELECTED FOR AN ANGIOPLASTY PROCEDURE IN THE ANTERIOR TIBIAL VESSEL TO TREAT CRITICAL LIMB ISCHEMIA (CLI). DURING THE PROCEDURE, THE WIRE DETACHED INSIDE THE HEAVILY CALCIFIED VESSEL. THE DEVICE FRAGMENT WAS TOO DIFFICULT TO RETRIEVE SO WAS SECURED AT THE DISTAL END OF THE ANTERIOR TIBIAL VESSEL. THE PROCEDURE WAS CANCELLED/RESCHEDULED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22125887 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE IN A PERIPHERAL INTERVENTION PROCEDURE. THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION IN THE LEFT POPLITEAL ARTERY. VASCULAR ACCESS WAS PERFORMED VIA CONTRALATERAL APPROACH, AND AN ATTEMPT WAS MADE TO CROSS THE OCCLUSION WITH THE WIRE AND A NON-BOSTON SCIENTIFIC SHOCKWAVE DEVICE. IT WAS NOTED THAT THE TIP OF THE WIRE WAS OUTSIDE THE SHOCKWAVE DEVICE. THE LESION WAS TREATED WITH 120 PULSES, AND WHEN PULLING THE DEVICE AND WIRE BACK, IT WAS OBSERVED THAT THE TIP OF THE WIRE HAD SHEARED OFF. IT WAS NOTED THE DEVICE WAS PARTIALLY EXPLANTED, A PORTION REMAINED IMPLANTED, AND THE PROCEDURE WAS NOT COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21946297 ↗
• InjuryApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED, AND ADDITIONAL INTERVENTION WAS PERFORMED. THE 60 TO 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) TO PROXIMAL ARTERY. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS USED FOR TREATMENT. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE THIS GUIDEWIRE THROUGH A NON-BSC GUIDING CATHETER IN ORDER TO CROSS THE LESION. THE PHYSICIAN ENCOUNTERED DIFFICULTY IN CROSSING THE LESION AND APPLIED PRESSURE AND TORQUE TO THE PROXIMAL END OF THE GUIDEWIRE IN AN EFFORT TO NAVIGATE THROUGH THE CALCIFIED AREA. SUBSEQUENTLY, IT WAS OBSERVED THAT THE DISTAL SPRING COIL SEGMENT OF THE GUIDEWIRE, MEASURING APPROXIMATELY 2 TO 3 CM, HAD DETACHED. THE DETACHED PORTION OF THE GUIDEWIRE WAS SUCCESSFULLY SNARED AND RETRIEVED INTACT. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930144 ↗
• MalfunctionNov 4, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT IMPROPER LABELLING OCCURRED. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING PREPARATION, UPON OPENING, IT WAS NOTED THAT THE LENGTH OF THE DISTAL PART WHERE THE TAPER BEGINS AND ENDS WAS EXTREMELY LONG FOR THE DESCRIPTION ON BOX. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598871 ↗
• MalfunctionOct 31, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR LOWER EXTREMITY ANGIOPLASTY. HOWEVER, UPON UNPACKING, IT WAS NOTED THAT THE TAPER TIP ON THE GUIDEWIRE WAS MUCH LONGER THAT WHAT WAS INDICATED IN THE PACKAGE. THE PROCEDURE WAS COMPLETED USING A 300CM SAVION GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578744 ↗
• InjuryJul 25, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND WAS SNARED TO REMOVE THE BROKEN PIECE. THE TARGET LOCATION WAS LOCATED IN THE TIBIAL ARTERY. A V-14 CONTROL WIRE WAS SELECTED AND ADVANCE THOUGH A NON-BOSTON SCIENTIFIC CATHETER. WHEN THE WIRE WAS PULLED BACK ACROSS SOME PLAQUE, THE TIP SHEARED OFF. THE BROKEN PIECE WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832715 ↗
• InjuryJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP DETACHED AND REMAINED IN THE PATIENT. A 300CM V-14 GUIDEWIRE WAS SELECTED FOR USE IN A BELOW-THE-KNEE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE POSTERIOR DORSALIS PEDIS. A RUBICON 14 WAS ADVANCED OVER THE V-14 GUIDEWIRE. AFTER WITHDRAWING THE V-14 GUIDEWIRE FROM THE RUBICON 14, IT WAS OBSERVED THAT PART OF THE GUIDEWIRE TIP REMAINED IN THE FOOT. ADDITIONAL INTERVENTION WAS PERFORMED. HOWEVER, ATTEMPTS TO RETRIEVE THE GUIDEWIRE TIP WERE UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19618367 ↗
• MalfunctionJun 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS USED DURING THE PROCEDURE; HOWEVER, THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459257 ↗
• InjuryFeb 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE TIP DETACHED AND COULD NOT BE REMOVED. A SHORT TAPER 300CM STRAIGHT TIP V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT V-14 WIRE END TIP BROKE OFF DURING ITS USE INTRAOPERATIVELY. THE END OF THE WIRE THAT BROKE OFF WAS ATTEMPTED TO BE RETRIEVED WITH A SNARE, HOWEVER, IT WAS UNSUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18642903 ↗
• InjuryJan 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ARM ARTERY. A 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE OFF IN THE ARTERY. THE DEVICE WAS REMOVED, AND ALL OF THE FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596815 ↗
• MalfunctionJan 9, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14DEC2024. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. DURING PREPARATION OF A 300CM STRAIGHT TIP V-14 CONTROL WIRE, IT WAS NOTED THAT THE END WIRE WAS NOT SEALED CORRECTLY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS RESULT REVEALED GUIDEWIRE COATING WAS PEELED/SHEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478196 ↗
• InjuryNov 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE SEVERELY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY/POPLITEAL ARTERY. A 300CM STRAIGHT TIP V-14 SHORT TAPER CONTROL GUIDE WIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE TIP OF THE WIRE BROKE OFF DURING THE USE OF JETSTREAM. THE BROKEN PIECE OF WIRE WAS SNARED AND RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136305 ↗
• MalfunctionSep 28, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A SHORT TAPER 300CM STRAIGHT TIP V-14 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, WHILE USING THE DEVICE, THE TIP BROKE AND IT REMAINED INSIDE THE PATIENT'S ARTERY. THE PATIENT WAS BEING ADMITTED AND WAS EVENTUALLY DISCHARGED FROM THE HOSPITAL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840015 ↗
• MalfunctionAug 1, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT WAS PRESENTED WITH THROMBOSIS OF HERO GRAFT AND UNDERWENT A SUCCESSFUL DECLOT PROCEDURE WITH RETROGRADE ACCESS. FOLLOWING A 300CM STRAIGHT TIP V-14 SHORT TAPER GUIDEWIRE, AN OPTICROSS 18 VASCULAR IMAGING CATHETER WAS ADVANCED ACROSS THE LESION TO VERIFY THE RESULT; HOWEVER, DURING THE PROCEDURE, THE MOTORDRIVE UNIT PROMPTED AN OVERLOAD ERROR AND SHUT DOWN. THE PHYSICIAN ATTEMPTED TO REINITIATE THE PROCEDURE, BUT THE SAME ERROR OCCURRED. ANGIOGRAPHY CONFIRMED THAT THE OPTICROSS 18 VASCULAR IMAGING CATHETER WAS ENTANGLED WITH THE 300CM STRAIGHT TIP V-14 SHORT TAPER GUIDEWIRE DISTAL TO THE SHEATH. WHEN AN ATTEMPT WAS MADE TO PULL THE WIRE, THE VASCULAR IMAGING CATHETER COULD NOT PASS INTO THE SHEATH. FINALLY, THE PHYSICIAN CUT BOTH THE IMAGING CATHETER AND THE GUIDEWIRE OUTSIDE THE SHEATH. THE ENTANGLED DEVICES WERE REMOVED OUT OF THE PATIENT BODY BY PULLING WITH FORCE THROUGH THE SHEATH. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436022 ↗