V-14™ Control Wire™ H74939216730020Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729799238), received between Feb 6, 2019 and Jul 14, 2025 — classified as 16 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN A BELOW THE KNEE VESSEL. A V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INSERTION INTO THE CATHETER, THE COIL DEPLOYMENT WAS INTERRUPTED. CONSEQUENTLY, THE PROCEDURE WAS TERMINATED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496180 ↗
• InjuryMay 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING OF THE GUIDEWIRE TIP DETACHED, REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED POSTERIOR TIBIAL ARTERY. AFTER PLACING A RUBICON 14 CATHETER, A V-14 GUIDEWIRE WAS ADVANCED. HOWEVER, WHILE CROSSING THE LESION, WHEN THE GUIDEWIRE WAS BEING ADVANCED AND RETRACTED, THE HYDROPHILIC COATING OF THE GUIDEWIRE TIP DETACHED AND REMAINED IN THE PATIENT. THE DETACHED COATING WAS CAPTURED AND REMOVED WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031522 ↗
• MalfunctionFeb 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS RIGHT ANTERIOR TIBIAL ARTERY. DURING PROCEDURE, V14 WIRE AND NON-BOSTON SCIENTIFIC CATHETER WERE ADVANCED INTO THE ARTERY, AND VESSEL WAS INFLATED BY A 3MM BALLOON. UPON REMOVAL, BROKEN PIECE SEEN ON ANGIOGRAM. THE BROKEN PIECE WAS RETRIEVED WITH THE CATHETER AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308399 ↗
• InjuryJan 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND PORTION OF THE DEVICE FRAGMENT REMAINED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR TIBIAL ARTERY. A V-14 CONTROL WIRE WAS SELECTED FOR USED. DURING PROCEDURE, THE V-14 CONTROL WIRE WAS ADVANCED ALONG WITH A NON-BOSTON SCIENTIFIC CATHETER. IT WAS NOTED THAT WHEN THE V-14 CONTROL WIRE WAS PULLED BACK, THE TIP BROKE OFF IN THE PATIENT. PART OF THE WIRE WAS UNABLE TO BE RETRIEVED AND REMAINED INSIDE THE PATIENT. A SECOND V-14 WIRE WAS ADVANCED WITH NON-BOSTON SCIENTIFIC CATHETER AND THERE WAS NO ISSUE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21276998 ↗
• MalfunctionNov 12, 2024Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRES COATING HAD PEELED, AND PARTIAL DETACHMENT HAD OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SEGMENT OF THE POPLITEAL ARTERY. A 300 CM V-14 CONTROL WIRE WITH AN ANGLED TIP WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE ENCOUNTERED RESISTANCE AND DEMONSTRATED INSUFFICIENT PUSHABILITY, PROMPTING THE PHYSICIAN TO WITHDRAW THE DEVICE. UPON INSPECTION, THE GUIDEWIRE WAS FOUND TO BE BENT AT THE TIP WITH AREAS OF COATING LOSS. THE DEVICE WAS REMOVED PARTIALLY IN ONE PIECE, WITH A DETACHED SEGMENT FOUND WITHIN THE INTRODUCER SHEATH UPON EXTRACTION. IMAGING CONFIRMED THAT NO COATING FRAGMENTS OR WIRE MATERIALS WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW GUIDEWIRE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668812 ↗
• MalfunctionOct 22, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A GUIDEWIRE WAS ENTRAPPED INSIDE THE CATHETER. THIS 2.1 JETSTREAM XC ATHERECTOMY CATHETER WAS CHOSEN FOR TREATMENT FOR OCCLUSION OF THE POPLITEAL LESION. A 0.035GW WAS USED TO CROSS THROUGH THE POPLITEAL AND ANTERIOR TIBIAL ARTERY AND, THEN AN EXCHANGE WAS MADE TO A 0.014 V-14 CONTROL WIRE. THE JETSTREAM WAS ADVANCED AND MADE TWO PASSES WITH BLADES DOWN BEFORE THE GUIDEWIRE BECAME KINKED. THE SYSTEM WAS REMOVED TOGETHER, AND A NEW 0.014 V-14 CONTROL WIRE WAS ATTEMPTED TO ADVANCED; HOWEVER, WHILE STILL OUTSIDE THE PATIENT THE NEW GUIDEWIRE WAS DIFFICULT TO INSERT AND TRACK THROUGH THE JETSTREAM CATHETER. THE PROCEDURE WAS ABORTED (USING LOCAL ANESTHESIA) WITHOUT ANY CLINICAL IMPROVEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509172 ↗
• InjuryAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE FRACTURED DEVICE WAS LEFT UNRETRIEVED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED MID ANTERIOR TIBIAL ARTERY. A 300CM V-14 CONTROL WIRE WAS SELECTED FOR USE IN A LOWER EXTREMITY INTERVENTION. HOWEVER, DURING CROSSING THE LESION, IT WAS NOTED THAT PART OF THE WIRE FRACTURED OUTSIDE THE VESSEL LUMEN. AN ATTEMPT WAS MADE TO SNARE THE BROKEN PART, BUT UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO STENT OVER THE AREA WITH A CORONARY STENT, BUT STILL UNSUCCESSFUL. A BALLOON WAS USED AND NON- LIMITING FLOW WAS NOTED. THE BROKEN PART OF THE WIRE WAS NOT REMOVED AND REMAINED IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20077497 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE BREAK OCCURRED. A 300CM ANGLED TIP V-14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE BROKE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19301215 ↗
• MalfunctionJun 28, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE GUIDEWIRE WAS ENTRAPPED IN THE CATHETER. A V14 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE V14 CONTROL WIRE BECAME ENTRAPPED IN A NON-BSC CATHETER. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221317 ↗
• MalfunctionMay 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT LEG ANGIOPLASTY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 300CM ANGLED TIP V-14 CONTROL WIRE WAS ADVANCED. HOWEVER, WHILE CROSSING THE LESION, THE TIP OF THE WIRE BROKE OFF IN THE DISTAL TIBIA. ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940727 ↗
• InjuryMar 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS, SEVERELY CALCIFIED AND CHRONIC TOTALLY OCCLUDED TIBIAL ARTERY. A 300CM ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE BROKE OFF IN THE VESSEL. THE PHYSICIAN TRIED TO SNARE IT, BUT IT WAS TOO EMBEDDED AND COULD NOT BE RETRIEVED. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16581813 ↗
• MalfunctionFeb 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE OCCURRED. VASCULAR ACCESS SITE WAS OBTAINED VIA FEMORAL ARTERY. THE 100% STENOSED TARGET LESION WITH A SIGNIFICANT BEND OF MORE THAN 45 DEGREES WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY POPLITEAL ARTERY. A 300CM V-14 CONTROL WIRE WAS USED DURING POPLITEAL ANGIOPLASTY CASE. HOWEVER, THE BLACK POLYMER SLEEVE SECTION OF THE GUIDEWIRE PEELED OFF. THE DAMAGED DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NEW V-14 CONTROL WIRE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354613 ↗
• MalfunctionDec 14, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH TIBIAL ARTERY BLOCKAGE AND UNDERWENT BALLOON ANGIOPLASTY. AFTER GAINING VASCULAR ACCESS VIA THE FEMORAL ARTERY, A 3.0MM X 80MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INTRODUCTION, THE BALLOON GOT STUCK ON A 300CM ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE AND WOULD NOT MOVE FURTHER INTO THE TARGET LESION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976198 ↗
• InjuryDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED BELOW-THE-KNEE VESSEL WITH NORMAL EJECTION FRACTION. A 300CM ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE AND LODGED INSIDE THE PATIENT. THE PHYSICIAN DID NOT ATTEMPT TO REMOVE THE DETACHED TIP AS IT WAS LODGED IN THE VERY DISTAL DORSAL PEDIS, AND THE PROCEDURE WAS ABANDONED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15898495 ↗
• MalfunctionNov 18, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT COATING ISSUE OCCURRED AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS SCHEDULED FOR ARTERIOGRAPHY PLUS LOWER LIMB ANGIOPLASTY. THE 70% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY/MODERATELY CALCIFIED LOWER LIMB. A SHORT TAPER 300CM ANGLED TIP V-14 CONTROL WIRE WAS USED WITH A NON-BOSTON SCIENTIFIC SUPPORT CATHETER DURING THE PROCEDURE. HOWEVER, THE GUIDEWIRE LOST IT'S HYDROPHILIC COATING, SO IT DID NOT NAVIGATE. THE ENTIRE SYSTEM WAS REMOVED, AND THE GUIDEWIRE WAS OBSERVED WITH A HIGH POTENTIAL OF TIP DETACHMENT. THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829544 ↗
• MalfunctionNov 18, 2022Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE OCCURRED. THE PATIENT WAS SCHEDULED FOR ARTERIOGRAPHY AND LOWER LIMB ANGIOPLASTY. THE 70% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. A 300CM ANGLED TIP V-14 CONTROL WIRE WAS ADVANCED WITH A 0.14 NON-BOSTON SCIENTIFIC SUPPORT CATHETER. HOWEVER, WHILE THE WIRE WAS INSIDE THE PATIENT, THE GUIDEWIRE LOSES ITS HYDROPHILIC COATING AND FAILED TO NAVIGATE. THE ENTIRE SYSTEM WAS REMOVED INTACT. THE PROCEDURE WAS CANCELLED/RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826759 ↗
• MalfunctionMar 29, 2022Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED FEMORAL ARTERY. A 300CM ANGLED TIP V-14 CONTROL WIRE WAS ADVANCED TO CROSS THE LESION, HOWEVER, FAILED TO CROSS THE LESION AND THE TIP GOT DETACHED. THE DETACHED PART WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13943721 ↗
• InjuryJan 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED VIA MEDWATCH 5105441. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER LEG. A 300CM ANGLED TIP V-14 SHORT TAPER CONTROL GUIDE WIRE WAS USED IN AN ARTERIOGRAM PROCEDURE. HOWEVER, THE DEVICE WAS DETACHED AND A FOREIGN OBJECT WAS NOTED IN THE RIGHT ANTERIOR TIBIAL ARTERY UNDER FLUOROSCOPY. THE DEVICE WAS RETRIEVED WITH NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13335324 ↗
• MalfunctionJan 21, 2022Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-DEC-2021. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. DURING UNPACKING OF A 300CM V-14 CONTROL WIRE, THE TIP WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED DISTAL TIP DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315941 ↗
• MalfunctionNov 2, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 300CM ANGLED TIP V-14 CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN PULLED THE GUIDEWIRE OUT OF THE CATHETER, THE TIP WAS ALL COILED UP AND BROKE OFF. THE TIP PORTION OF THE DEVICE WAS ALREADY OUTSIDE OF THE BODY AT THE TIME OF FRACTURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE SURGEON NOTED THAT THE TIBIAL VESSEL IN WHICH HE WAS ATTEMPTING TO TRAVERSE WAS EXTREMELY CALCIFIED AND THAT THE TIP BEGAN TO DETACH FROM THE BODY OF THE GUIDE WIRE DUE TO IT BECOMING FIXED IN THE CALCIUM. THE GUIDE WIRE WAS REMOVED COMPLETELY INTO THE DIAGNOSTIC CATHETER BEFORE THE TIP COMPLETELY DETACHED FOR THE WIRE BODY. THE ENTIRE WIRE/TIP AND CATHETER WERE REMOVED AND THE TIP COMPLETELY DETACHED IN THE CATHETER DURING THIS PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737970 ↗
• InjuryAug 27, 2021Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED VIA FACILITY MEDWATCH# 2400930000-2021-8017 THAT GUIDE WIRE TIP DETACHMENT OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 60% STENOSED TARGET LESION CONTAINING 90 DEGREES BEND WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. A 2.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION AROUND THE BEND. THE BALLOON WAS INITIALLY INFLATED AT 14 ATMOSPHERES FOR 3 MINUTES. HOWEVER, DURING THE SECOND INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED AND THE DEVICE WAS REMOVED NORMALLY OVER A 300CM ANGLED TIP V-14 CONTROL WIRE. WHILE ATTEMPTING TO EXTRACT THE BALLOON AND THE WIRE FOR ANGIOGRAM, IT WAS FOUND THAT THE WIRE TIP WAS FRACTURED AND STUCK AT THE JUNCTION OF THE PLANTAR ARTERIES IN THE POSTERIOR TIBIAL ARTERY. APPROXIMATELY TWO HOURS WAS SPENT IN ATTEMPTING TO EXTRACT THE WIRE FRAGMENT USING A 3.2 FR NON-BOSTON SCIENTIFIC SNARE. FINALLY, THE WIRE FRAGMENT WAS RETRACTED TO THE DISTAL SUPERFICIAL FEMORAL ARTERY LEVEL. HOWEVER, THE WIRE TIP EMBOLIZED INTO THE DORSALIS PEDIS AND ACCESS INTO THE DORSALIS PEDIS WAS GAINED. A NON- BOSTON SCIENTIFIC ASPIRATION CATHETER WAS USED AND WAS ABLE TO ASPIRATE THE WIRE FRA

  Patient problems: Foreign Body Embolism

  MAUDE report 12379766 ↗
• InjuryMay 10, 2021Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THE SEVERELY OCCLUDED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LOWER LIMB. A 300CM V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED INTO THE VASCULAR CAVITY THROUGH THE GUIDE CATHETER. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. UPON RETRIEVAL OF THE GUIDEWIRE, THE TIP WAS FRACTURED AND FELL OFF INTO THE MIDDLE SEGMENT OF ANTERIOR TIBIAL ARTERY. REPEATED ANGIOGRAPHY SHOWED THAT THE BROKEN TIP WAS NOT FOUND IN THE VASCULAR LUMEN, BUT IN THE GAP BETWEEN THE VASCULAR LUMEN AND MUSCLE. THE VASCULAR ITSELF HAD PLAQUE SCLEROSIS OCCLUSION, SO THE PASSING RATE IS LOW. WHEN PASSING THROUGH THE NARROW PART, THERE WILL INEVITABLY BE PRESSURE AND RESISTANCE WHEN WITHDRAWING. ANGIOGRAPHY INDICATED THAT THE BROKEN TIP WAS NOT IN THE VASCULAR CAVITY, AND THERE WERE NO SEVERE LOWER LIMB ISCHEMIA SYMPTOMS, SO IT WAS NOT REMOVED. THE PROCEDURE WAS CANCELLED. AMPUTATION MIGHT BE REQUIRED AS THE PATIENT HAD SEVERE OCCLUSION AS PER MEDICAL OPINION. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED. POST PROCEDURE, THE PATIENT RECOVERED FAIRLY WELL, AND NO SEVERE LOWER LIMB ISCHEMIA SYMPTOMS APPEARED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11798825 ↗
• InjuryApr 28, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE WIRE BROKE OFF AND WAS SNARED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 300CM V-14 CONTROL WIRE WAS USED TOGETHER WITH A RUBICON GUIDE CATHETER. DURING WITHDRAWAL, AFTER BALLOON ANGIOPLASTY, THERE WAS TROUBLE REMOVING THE DEVICE AS THE DISTAL TIP OF THE WIRE GOT STUCK. A RUBICON WAS USED TO UNFOLD THE DEVICE BUT THE TIP BROKE OFF. SUBSEQUENTLY, THE RUBICON AND SOME OF THE WIRE WAS REMOVED. THE FRACTURED PART OF THE WIRE WAS SNARED. PER PHYSICIAN'S OPINION, THE WIRE WAS DEFECTIVE AND THAT IT WAS NOT BEING FORCED IN ANYWAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER COMPLICATIONS REPORTED AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739690 ↗
• InjuryOct 21, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. A 300CM ANGLED TIP V-14 CONTROL WIRE GUIDEWIRE WAS ADVANCED TO THE LESION. HOWEVER, WHEN ATTEMPTING TO CROSS THE LESION AND PULLING THE WIRE BACK TO FIND A BETTER CHANNEL IN THE LESION TO CROSS, THE COATING AT THE TIP WAS PULLED OFF OF THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD 95% STENOSIS LOCATED IN THE HIGHLY CALCIFIED AND MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY. THE DEVICE WAS PULLED OUT BY SNARING. THE COVERING WAS NOT RECOVERED BECAUSE IT POSED A GREATER THREAT TO THE PATIENT THAN LEAVING IT IN THE OCCLUDED VESSEL. THE PATIENT WAS UNHARMED. THE PATIENT SHOWED NO ADVERSE EFFECT IN OR AND WAS TRANSPORTED TO PACU WITHOUT ISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 10711595 ↗
• InjurySep 23, 2020Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE AND VESSEL OCCLUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERONEAL ARTERY. A 300CM V-14 CONTROL WIRE WAS ADVANCED AND PLACED INTO THE LESION. HOWEVER, DURING REMOVAL THROUGH THE 3.0MM X 80MM X 150CM COYOTE BALLOON CATHETER LUMEN, THE COATING OF THE GUIDEWIRE SHEARED OFF AND WAS CONFIRMED DURING VISUAL INSPECTION. RESISTANCE WAS FELT DURING REMOVAL OF THE WIRE THROUGH THE BALLOON. THE PHYSICIAN REMOVE THE BALLOON CATHETER. THERE WAS A GOOD DISTAL RUN-OFF FLOW IN THE PERONEAL ARTERY. AFTER THE INTERVENTION, THE PHYSICIAN DID ANOTHER DISTAL RUN-OFF OF THE PERONEAL ARTERY TO SEE IF THE COATING OCCLUDED THE VESSEL AND IT DID. SO, THE PHYSICIAN PERFORM BALLOON ANGIOPLASTY WHERE THE COATING WAS SITTING. AFTER THAT, ANOTHER RUN-OFF WAS PERFORMED. THIS TIME, GOOD BLOOD FLOW WAS ESTABLISHED. THE PEELED OFF COATING WAS NOT REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT HOME THE SAME DAY.

  Patient problems: Device Embedded In Tissue or Plaque; Stenosis

  MAUDE report 10574554 ↗