V-18™ Control Wire™ M001468540Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 08714729070207), received between Aug 22, 2018 and Sep 2, 2026 — classified as 1 death, 53 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (63 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 151 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Detachment of Device or Device Component

  It was reported that the guidewire fractured requiring additional intervention.The target lesion was a Chronic Total Occlusion (CTO) and located in the superior mesenteric artery (SMA). A V-18 Control Wire was advanced to cross the lesion during an SMA stenting procedure. While crossing the lesion, the tip of the guidewire fractured. The fractured tip was successfully snared and removed. The procedure was completed using another V-18 Control Wire. There were no patient complications as a result of the event..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569938 ↗
• MalfunctionAug 20, 2026Material Integrity Problem

  The coating of the wire distal is removed from the patient's body during the procedure. The 70% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel. A 300cm, 8cm V-18 Control Wire was selected for use in an angioplasty procedure in the leg. During the procedure, the distal coating of the guidewire was removed from the patients body. The procedure was completed using with another of the same device and there were no patient complications as a result of this event. It was further reported that the distal coating of the guidewire appeared to peel. Resistance or unusual difficulty was encountered during advancement, manipulation of the guidewire. The coating removal occurred at the distal tip of the guidewire.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349118 ↗
• MalfunctionAug 13, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240191 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE BIFURCATION OCCURRED. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE IN A BALLOON ANGIOPLASTY. DURING THE PROCEDURE, THE DISTAL END OF THE GUIDEWIRE WAS OBSERVED TO BE BIFURCATED. THE PROCEDURE WAS COMPLETED WITH A NEW HYDROPHILIC-COATED STEERABLE GUIDEWIRE. NO PATIENT COMPLICATIONS OR HARM WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261269 ↗
• InjuryJan 8, 2026Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 300CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED TO TREAT PERIPHERAL ARTERY DISEASE (PAD) IN AN ENDOVASCULAR THERAPY (EVT). DURING THE PROCEDURE, THE TIP OF THE GUIDEWIRE BECAME LODGED IN A BRANCH. TO EXTRACT IT, THE GUIDEWIRE WAS PULLED, RESULTING IN ITS REMOVAL FROM THE MICROCATHETER. AT THAT POINT, IT WAS DISCOVERED THAT THE TIP OF THE GUIDEWIRE REMAINED IN THE SFA, CONFIRMING A FRACTURE. A GOOSENECK SNARE WAS USED TO RETRIEVE THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND A STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004882 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURAL PREPARATION, THE PHYSICIAN DISCOVERED THAT THE GUIDEWIRE HAD FRACTURED PRIOR TO USE. THE GUIDEWIRE WAS IMMEDIATELY REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872595 ↗
• InjuryDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE BROKE. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS BROKE AND THE BROKEN SEGMENT WAS IMMEDIATELY REMOVED, PREVENTING A POTENTIALLY IRREVERSIBLE COMPLICATION CAUSING EXTENSION OF THE PROCEDURE TIME. A NEW GUIDEWIRE WAS PROMPTLY REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864813 ↗
• InjuryDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED REQUIRING INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL BELOW THE KNEE. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP PART OF THE DEVICE WAS SEPARATED. THERE WAS RESISTANCE IN REMOVING THE DEVICE AND THE DEVICE PART WAS CAUGHT WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT NO REMNANTS OF THE DETACHED TIP REMAINED INSIDE THE PATIENT'S BODY, AS THE DETACHED PORTION WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. DURING THE PROCEDURE, THE V-18 GUIDEWIRE WAS USED SPECIFICALLY IN THE ANTERIOR TIBIAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850310 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND THE DEVICE FRAGMENT WAS NOT RETRIEVED. A 300 CM, 8 CM V-18 CONTROL WIRE WAS SELECTED FOR USE IN A PERIPHERAL ANGIOGRAM WITH INTERVENTION PROCEDURE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY (PTA). THE WIRE WAS MANIPULATED PRIOR TO INSERTION TO CREATE AN ANGLE AND WAS USED IN A CHALLENGING CHRONIC TOTAL OCCLUSION (CTO). THE WIRE WAS INTRODUCED THROUGH AN INTRODUCER TO SHAPE THE TIP, THEN ADVANCED THROUGH A 6F SHEATH AND A NON-BOSTON SCIENTIFIC SUPPORT CATHETER. DURING NAVIGATION, THE DISTAL TIP OF THE WIRE DETACHED IN THE PTA AND WAS LEFT IN THE VESSEL. A NEW V-18 CONTROL WIRE WAS SUBSEQUENTLY INSERTED, AND THE PROCEDURE CONTINUED; HOWEVER, THE VESSEL COULD NOT BE OPENED, WHICH WAS UNRELATED TO DEVICE PERFORMANCE, AS THE ARTERY WAS COMPLETELY OCCLUDED FROM THE START. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 23768366 ↗
• MalfunctionDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT AN ISSUE INVOLVING THE GUIDEWIRE COATING OCCURRED. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE IN A BALLOON DILATATION PROCEDURE OF THE LEFT LOWER LIMB. A SUPPORTING CATHETER WAS UTILIZED TO ACCESS AND OPEN THE VESSEL OVER THE 0.018 GUIDEWIRE. AFTER THE GUIDEWIRE ENTERED THE PATIENT, THE COATING WAS OBSERVED TO HAVE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. IT WAS FURTHER REPORTED THAT THE SOFT TIP AT THE FRONT END OF THE GUIDEWIRE PEELED OFF DURING THE PROCEDURE, AND THE COATING ON THE POSTERIOR PART OF THE GUIDEWIRE WAS FOUND TO BE DETACHED. THIS DAMAGE OCCURRED DURING USE. THE LESION ITSELF WAS NOT PARTICULARLY CHALLENGING, AND THE PATIENTS ANATOMY DID NOT CONTRIBUTE TO THE ISSUE. THE GUIDEWIRE WAS INSERTED THROUGH AN 18-FRENCH SUPPORT CATHETER BUT BECAME STUCK AT THE DISTAL END. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE GUIDEWIRE, THE COATING AT THE DISTAL END FRACTURED. THE EVENT WAS NOT ATTRIBUTED TO ANY PATIENT FACTORS, AND PROCEDURAL FACTORS WERE NOT BELIEVED TO HAVE CONTRIBUTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760193 ↗
• MalfunctionDec 4, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. AN 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE IN A VESSEL OF BELOW THE KNEE FOR STENT IMPLANTATION. DURING UNPACKING, IT WAS NOTED THAT THE GUIDEWIRE WAS FRACTURED. 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 23720025 ↗
• MalfunctionNov 26, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND COATING ISSUE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL OF BELOW THE KNEE. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE WIRE WAS TRAPPED BY CALCIFICATION. UPON WITHDRAWAL, THE COATING PEELED OFF. WHEN CHECKED OUTSIDE THE PATIENT, UNUSUAL RESISTANCE WAS ALSO FELT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING WITHDRAWAL, STRONG RESISTANCE WAS ENCOUNTERED, AND THERE WAS CONCERN THAT THE DEVICE MAY SEPARATE. THE MICROCATHETER WAS PRESSED AGAINST THE LESION AS MUCH AS POSSIBLE AND THE DEVICE WAS CAREFULLY WITHDRAWN IN A SIMPLE PULL-OUT MANNER, ENSURING THAT EVEN IN THE EVENT OF SEPARATION, IT WOULD REMAIN INSIDE THE MICROCATHETER. UPON INSPECTION OUTSIDE THE BODY, THE COATING AT THE DISTAL TIP OF THE DEVICE APPEARED TO BE DAMAGED, AND USE WAS DISCONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656928 ↗
• InjuryNov 24, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HYDROPHILIC GUIDEWIRE FRACTURE OCCURRED, REQUIRING ADDITIONAL DEVICE. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT LOWER LIMB. A 300CM, 8CM V-18 CONTROL WIRE GUIDEWIRE WAS SELECTED FOR RIGHT LOWER LIMB ANGIOPLASTY. DURING THE PROCEDURE, THE GUIDEWIRE COATING WAS STRETCHED AND DETACHED FROM THE GUIDEWIRE UPON PENETRATING INTO THE POSTERIOR TIBIAL ARTERY (PTA). THE GUIDEWIRE WAS REMOVED. HOWEVER, A SHORT COATING WAS LEFT IN THE DISTAL PERONEAL ARTERY. THEREFORE, A STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23632954 ↗
• MalfunctionNov 10, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ADVANCEMENT DIFFICULTY OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE BELOW THE KNEE VESSEL, A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PRODUCT WAS INSERTED INTO THE CATHETER, HOWEVER, THE COIL WAS INTERRUPTED. THE PROCEDURE WAS CANCELED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511551 ↗
• MalfunctionOct 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. THIS 300CM, 8CM V-18 CONTROL WIRE WAS USED DURING AN INTERVENTIONAL RADIOLOGY PROCEDURE. POST PROCEDURE, A WIRE FRAGMENT WAS LEFT INSIDE THE PATIENT. MULTIPLE GUIDE WIRES WERE UTILIZED DURING THE CASE, MAKING IT IMPOSSIBLE TO DETERMINE WHICH SPECIFIC WIRE WAS RESPONSIBLE. THE WIRE FRAGMENT WAS NOT REMOVED, AS IT WAS DETERMINED THAT REMOVAL WAS NOT IN THE PATIENT'S BEST INTEREST AT THAT TIME. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23397222 ↗
• MalfunctionOct 22, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. HOWEVER, DURING THROMBUS ASPIRATION, IT WAS NOTED THAT THE GUIDEWIRE BENT INSIDE THE CATHETER DUE TO UNEVEN STRESS ON THE GUIDEWIRE. CONSEQUENTLY, THE USE OF THE DEVICE WAS DISCONTINUED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND NON-CALCIFIED SUPERFICIAL FEMORAL ARTERY. MOREOVER, THE PATIENT WAS LOCALLY SEDATED WHEN THE ISSUE OCCURRED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360773 ↗
• MalfunctionOct 8, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE HYDROPHILIC COATING WAS FRACTURED, MIGRATED AND REMAINED INSIDE PATIENT. THE PATIENT UNDERWENT INTERVENTIONAL TREATMENT FOR RIGHT LOWER LIMB ARTERIOSCLEROTIC OCCLUSION. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COATING AT THE TIP OF THE WIRE WITH HYDROPHILIC COATING WAS FRACTURED AND FELL INTO THE ANTERIOR TIBIAL ARTERY. AFTER THE PROCEDURE, THE BLOOD SUPPLIED TO THE LOWER LIMBS OF THE PATIENT IMPROVED COMPARED TO BEFORE, AND THERE WERE NO PAIN OR OTHER DISCOMFORTS. ON (B)(6) 2025, THE IMAGING EXAMINATION CONFIRMED THAT THE FALLEN COATING HAD TRAVELLED THROUGH THE BLOODSTREAM TO THE EXTREMITIES AND COULD NOT BE REMOVED. THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23246325 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  THE STRENGTH OF THE SOFT TIP OF THE GUIDE WIRE WAS INSUFFICIENT. ON (B)(6) 2025, A PATIENT WAS TREATED FOR LEFT ILIAC VEIN COMPRESSION SYNDROME USING A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WITH A HYDROPHILIC COATING AND A SINGLE-CURVED ANGIOGRAPHY CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDE WIRE WAS FRACTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890155 ↗
• InjuryJul 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP BREAK OFF OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 300CM, 8CM V-18 POLYTIP GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE WIRE BROKE OFF. THE DEVICE WAS REMOVED FROM THE PATIENT SLOWLY AND CAREFULLY, AND 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 22670370 ↗
• MalfunctionJul 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL BELOW THE KNEE. A V-18 CONTROL WIRE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS FRACTURED WHEN CROSSING THE LESION. THE DEVICE WAS ABLE TO BE REMOVED IN ONE PIECE. 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 22515967 ↗
• MalfunctionJul 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL BELOW THE KNEE. A 300CM, 8CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, DUE TO HIGH CALCIFICATION, THE TIP WAS FRACTURED WHILE CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22482364 ↗
• MalfunctionMay 23, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT AND COATING SEPARATION OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 300CM, 8CMV-18 CONTROL GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS USED IN CONJUNCTION WITH AN 18 SUPPORT CATHETER FOR ACCESS. APPROXIMATELY HALF A MINUTE AFTER INSERTION INTO THE PATIENT, THE COATING OF THE GUIDEWIRE SEPARATED. A PORTION OF THE DETACHED COATING BECAME LODGED WITHIN THE SUPPORT CATHETER, RENDERING IT NONFUNCTIONAL. THE PROCEDURE WAS COMPLETED USING 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 22078153 ↗
• MalfunctionApr 30, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE WIRE COATING FELL OFF IN THE RIGHT ATRIUM. THE PATIENT UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE UNDER LOCAL ANESTHESIA. A 300CM V-18 CONTROL WIRE GUIDEWIRE WAS ADVANCE FOR USE. DURING GUIDEWIRE MANIPULATION IN THE BODY, THE PUNCTURE NEEDLE REMOVED A PORTION OF THE WIRE'S FRONT-END COATING, AND PART OF THE COATING FELL OFF IN THE RIGHT ATRIUM. IT WAS LEFT IN THE BODY, AS IT COULD NOT BE REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO HARM WAS DONE, AND THE PATIENT CURRENT CONDITION IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21939454 ↗
• InjuryApr 30, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED, AND FRAGMENT REMAINS INSIDE THE PATIENT'S BODY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED SUBCLAVIAN ARTERY OCCLUSION. A 300 CM, 8 CM V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE BECAME STUCK IN THE LESION PLAQUE. DURING RETRIEVAL, EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE CAUSING THE TIP TO FRACTURE. THE BROKEN TIP REMAINS IN THE PATIENT'S BODY. AN ATTEMPT TO REMOVE THE FRAGMENTS WAS UNSUCCESSFUL. THE PATIENT HAS PLANS TO GO TO ANOTHER HOSPITAL TO RETRIEVE THE GUIDEWIRE, BUT THE SPECIFIC TIME IS UNKNOWN. DUE TO V18 FRACTURING DURING THE TREATMENT OF COMPLETE OCCLUSION OF THE SUBCLAVIAN ARTERY, THE PHYSICIAN TRANSFERRED TO TREAT THE OCCLUSION OF THE RIGHT VERTEBRAL ARTERY. THE SUBCLAVIAN ARTERY REMAINS 100% OCCLUDED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE PATIENT WAS DISCHARGED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21936275 ↗
• MalfunctionFeb 6, 2025Material 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 A COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS SELECTED FOR USE. DURING PREPARATION FOR FLUSHING, IT WAS NOTED THAT THE COATING ON THE TIP OF THE GUIDE WIRE WAS FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21323293 ↗