SV WIRE 503558Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705032056052), received between Apr 16, 2018 and Jul 27, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50042597 ↗
• MalfunctionJun 10, 2024Fracture; Fracture

  AS REPORTED, THE PROXIMAL PART OF THE .018 180CM SV WIRE WAS STRIPED. IT WAS NOTED TO HAVE COME OFF AS A SPIRAL. THE DAMAGE WAS NOTED TO BE DURING USE (INSIDE OF THE PATIENT) AND AFTER WITHDRAWAL FROM THE PATIENT. THE GUIDEWIRE WAS EASILY REMOVED FROM THE PATIENT. A NEW UNKNOWN STIFFER WIRE WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE WIRE WAS ¿NORMAL¿ WHEN REMOVED FROM THE PACKAGE AND INSERTED INTO THE PATIENT. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE TIP OF THE GUIDEWIRE WAS NOT SHAPED AT ANY POINT DURING THIS PROCEDURE. THE LESION WAS IN THE PROXIMAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD MODERATE TORTUOSITY AND THE LESION WAS NOTED TO HAVE MODERATE CALCIFICATION. THE GUIDEWIRE WAS NOT BEING USED WITH ANOTHER DEVICE WHEN THE DAMAGE OCCURRED. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506881 ↗
• MalfunctionNov 8, 2023Fracture; Fracture

  AS REPORTED, THE ¿COIL PART¿ OF A 0.018" STRAIGHT TIP SV SHORT 180CM PERIPHERAL STEERABLE GUIDEWIRE (PGW) GOT STRETCHED DURING USE, THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED IN A PEDIATRIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. MULTIPLE ATTEMPTS TO OBTAIN SUPPLEMENTAL INFORMATION WERE MADE; HOWEVER, ADDITIONAL EVENT DETAILS WERE NOT PROVIDED. THE DEVICE WAS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, NO PRODUCT RETURN INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097237 ↗
• MalfunctionJun 30, 2023Fracture; Fracture

  AS REPORTED, THE COIL PART OF A .018 SHORT 180CM SV STEERABLE GUIDEWIRE RELEASED FROM THE CORE PART. THE GUIDEWIRE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PEDIATRIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: AS PER THE PRODUCT EVALUATION, A FRACTURED/SEPARATED AREA OF THE CORE WIRE OF THE UNIT PRESENTED EVIDENCE OF PLASTIC DEFORMATION ON THE DAMAGED END AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239493 ↗
• MalfunctionApr 4, 2023Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL TIP OF A .018¿ 180CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) WAS GETTING FRAYED WHEN ATTEMPTING TO CROSS THE LESION. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER UNKNOWN DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678227 ↗
• InjuryFeb 3, 2023Fracture; Fracture

  AS REPORTED, DURING THE WITHDRAWAL OF A 180CM SHORT SV-5 .018 STRAIGHT TIP GUIDEWIRE, THE DISTAL TIP OF THE GUIDEWIRE SEPARATED. THE GUIDEWIRE WAS REMOVED BY ADVANCING A NON-CORDIS MICRO CATHETER OVER THE GUIDEWIRE TO THE DISTAL END WITH AN ATTEMPT TO RETRACT. THE REMAINING FRAGMENTS WERE SNARED AND REMOVED FROM THE BODY WITH A NON-CORDIS SNARING DEVICE. TWO NON-CORDIS SNARING DEVICES WERE REPORTEDLY USED. AFTER THE SV-5 GUIDEWIRE WAS REMOVED, THE CASE WAS ABORTED DUE TO THE SIZE OF THE VESSEL. THIS WAS DURING A PLANNED STENTING OF A PATENT DUCTUS ARTERIOSUS. THERE WAS NO CALCIFICATION, TORTUOSITY, OR STENOSES OF THE TARGET VESSEL. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM ITS PACKAGING AND THERE WERE NO KINKS OR DAMAGES OBSERVED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16296589 ↗
• MalfunctionNov 28, 2022Fracture; Fracture

  AS REPORTED, THE COIL ON THE DISTAL END OF A PGW .018 180CM SV ST STEERABLE GUIDEWIRE WAS FOUND STRETCHED UPON REMOVAL FROM THE DISPENSER; THEREFORE, THE PHYSICIAN COULD NOT USE IT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SV WIRE. THERE WERE NO REPORTS OF PATIENT INJURY. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: A FRACTURED/SEPARATED CONDITION WAS NOTED ON THE CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15869961 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  AS REPORTED, A SV STEERABLE GUIDEWIRE .018 180CM WAS USED AND IT UNRAVELED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE WIRE UNRAVELED INSIDE THE PATIENT. THE DEVICE WAS NOT RESTERILIZED. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT RE-SHAPED BY THE USER. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION PRESENTS FRACTURED/SEPARATED CONDITION IN THE CORE WIRE NOTED TO BE SEPARATED INTO TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538533 ↗
• InjuryAug 30, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF A .018 SV STEERABLE STRAIGHT 180 CM GUIDEWIRE DE-SPIRALED/DETACHED DUE TO THE FRICTION OF AN UNKNOWN BALLOON IN COMBINATION WITH THE HEAVILY CALCIFIED BELOW THE KNEE (BTK) INTERVENTION. ONE SMALL PART DID DETACH, WHICH WAS SUCCESSFULLY SNARED WITHOUT ANY FURTHER COMPLICATIONS. THE HOSPITAL STAY WAS NOT PROLONGED FOR THE PATIENT. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THERE WAS NO DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE BEHAVED NORMALLY, AND TORQUE RESPONSE WAS GOOD. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325128 ↗
• MalfunctionMay 4, 2022Fracture; Fracture

  AS REPORTED, DURING PREPARATION THE PROXIMAL END OF A 0.018 180CM STRAIGHT SV SHORT STEERABLE GUIDEWIRE BECAME UNRAVELED AS IT WAS BEING MANUALLY SHAPED. AS A RESULT, THE GUIDEWIRE WAS NOT USED IN THE PATENT AND AN UNKNOWN GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO DAMAGES WERE OBSERVED TO THE DEVICE PRIOR TO OPENING AND REMOVING THE DEVICE FROM THE PACKAGING AND THE DEVICE HAS BEEN RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION ON 07-APR-2022 REVEALED A FRACTURE ON THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278167 ↗
• MalfunctionMar 9, 2022Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, DURING RIGHT HEART CATHETERIZATION THE .018 SV5 PERIPHERAL STEERABLE GUIDEWIRE WAS INSERTED THROUGH A NON-CORDIS CATHETER AND NOTED TO BE FRAYED WHEN EXITING THE CATHETER. THE PHYSICIAN IMMEDIATELY NOTED THIS ON FLUOROSCOPY AND REMOVED THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR A RIGHT HEART CATHETERIZATION PROCEDURE. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. NO LESION CALCIFICATION OR VESSEL TORTUOSITY WAS NOTED. THE PRODUCT WAS HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE; NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE AND NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THE DEVICE PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE NOR EXCESS FORCE USED DURING INSERTION. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712672 ↗
• MalfunctionMar 7, 2022Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, DURING RIGHT HEART CATHETERIZATION THE .018¿ SV5 PERIPHERAL STEERABLE GUIDEWIRE WAS INSERTED THROUGH A NON-CORDIS CATHETER AND NOTED TO BE FRAYED WHEN EXITING THE TIP OF THE CATHETER. THE WIRE WAS IMMEDIATELY REMOVED BY THE INTERVENTIONALIST. ANOTHER STEERABLE GUIDEWIRE WAS USED, AND THE CASE WAS THEN COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED FOR A RIGHT HEART CATHETERIZATION PROCEDURE. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. NO LESION CALCIFICATION OR VESSEL TORTUOSITY WAS NOTED. THE PRODUCT WAS HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE; NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE AND NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL FROM PACKAGE. THE DEVICE PREPPED ACCORDING TO THE IFU AND THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING THE PROCEDURE NOR EXCESS FORCE USED DURING INSERTION. THE PRODUCT WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE DEVICE WAS STORED PER LABELING AND OPENED IN A STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684186 ↗
• MalfunctionFeb 23, 2022Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, THE .018 SV SHORT 180CM ST PERIPHERAL GUIDEWIRE BEGAN TO FRAY AND UNRAVEL WHEN PASSING THROUGH THE NON-CORDIS MINI STICK 5F SHEATH CANNULA (NOT AGGRESSIVE). THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY. THE PRODUCT WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THE ACCESS SITE WAS THE RIGHT UPPER ARM. THE INTENDED PROCEDURE WAS A HEART CATHETERIZATION. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE DEVICE NOTICED PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE DID NOT KINK NOR BEND AT ANY TIME. THE OTHER DEVICES USED WITH THE PRODUCT DID NOT KINK NOR BEND AT ANY TIME. THE PRODUCT WAS NOT RESTERILIZED. THE WIRE WAS NOT RE-SHAPED BY THE USER. THE WIRE WAS REMOVED INTACT IN ONE PIECE FROM THE PATIENT BUT FRAYED. THE PROCEDURE WAS COMPLETED WITH A SECOND WIRE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584814 ↗
• InjuryJan 5, 2022Fracture; Fracture

  A 4.5 F NON -CORDIS SHEATH WAS INSERTED FROM THE JUGULAR REGION. TWO NON-CORDIS 014 GUIDEWIRES CROSSED THE LESION. A NON-CORDIS BALLOON CATHETER FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)WAS INSERTED BUT IT WAS UNABLE TO BE DELIVERED DUE TO SEVERE TORTUOUS AT THE RIGHT PULMONARY ARTERY (PA). TO EMPHASIS SUPPORT, ONE OF THE PGW .018 SV SHORT 180CM ST WIRES WAS USED. IT WAS USED TOGETHER WITH A NON -CORDIS MICROCATHETER. ONE OF THEM WAS USED BUT IT BROKE WHEN IT WAS ATTEMPTED TO BE SHAPED CURVE OUTSIDE THE PATIENT. THE DISTAL END OF THE GUIDEWIRE WAS BROKEN, AND THE COIL PART UNRAVELED BY PULLING THE DISTAL WIRE WITH HAND(S). IT WAS REPLACED WITH ANOTHER PGW .018 SV SHORT 180CM ST. THE DISTAL END WAS SHAPED CURVE AND IT CROSSED THE LESION. THE NON -CORDIS BALLOON CATHETER WAS DELIVERED BUT IT WAS DIFFICULT FOR IT TO CROSS THE TORTUOUS RIGHT PULMONARY ARTERY (PA) AND STENT IMPLANTED REGION. THE PHYSICIAN RETRACTED THE PGW .018 SV SHORT 180CM ST GUIDEWIRE BUT THE DISTAL END OF THE COIL DID NOT MOVE. THE PHYSICIAN SUSPECTED THE COIL IS UNRAVELED. THE PGW .018 SV SHORT 180CM ST GUIDEWIRE WAS SLOWLY RETRACTED THE GUIDEWIRE GOT SEPARATED AND THE COIL PART GOT STRETCHED. IT REMAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13163122 ↗
• MalfunctionJun 4, 2021Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, A .018¿ 180CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) HAS BEEN USED WITH A .018 (NON-CORDIS) INTRAVASCULAR ULTRASOUND (IVUS) CATHETER; HOWEVER, WHEN THE STEERABLE GUIDEWIRE WAS BEING PULLED OUT OF THE CATHETER (NON-CORDIS), THE WIRE WAS NOTED TO BE FRAYED. PHYSICIAN MADE SURE THAT THERE WERE NO LEFTOVER MATERIALS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: DURING PRODUCT ANALYSIS, A SEPARATION WAS FOUND AT THE CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937691 ↗
• MalfunctionJun 3, 2021Material Frayed; Material Frayed

  AS REPORTED, A .018¿ 180CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) HAS BEEN USED WITH A .018 (NON-CORDIS) INTRAVASCULAR ULTRASOUND (IVUS) CATHETER; HOWEVER, WHEN THE STEERABLE GUIDEWIRE WAS BEING PULLED OUT OF THE CATHETER (NON-CORDIS), THE WIRE WAS NOTED TO BE FRAYED. PHYSICIAN MADE SURE THAT THERE WERE NO LEFTOVER MATERIALS IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE OPERATOR WAS TRAINED TO USE THE DEVICE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928843 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, THE .018 X 180CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WAS STRETCHING. THE COMPLAINT SV WIRE WAS REPLACED WITH ANOTHER .018 X 180CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) BUT THE SAME ISSUE OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED AND THE DISTAL TIP OF THE COIL WIRE THAT SHOULD BE FUSED WITH THE CORE WIRE WAS NOTICED SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-CORDIS GUIDEWIRE. THIS WAS A PEDIATRIC PERIPHERAL ARTERY (PA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. AN UNKNOWN DIAGNOSTIC CATHETER WAS DELIVERED TO THE PA. THE .018 X 180CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WAS INSERTED, HOWEVER, THE POSITION OF THE DISTAL END AND THE SHAFT WAS OUT OF POSITION AND IT MIGHT HAVE BEEN STRETCHED. IT WAS CONFIRMED BY AN ANGIOGRAPHY WHICH WAS TAKEN BEFORE AN UNKNOWN PTA BALLOON CATHETER WAS INSERTED. THE WIRES WERE REMOVED FROM THE PATIENT. THE DEVICES WILL BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719643 ↗
• MalfunctionApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING USE, THE .018 X 180CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WAS STRETCHING. THE COMPLAINT SV WIRE WAS REPLACED WITH ANOTHER .018 X 180CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) BUT THE SAME ISSUE OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED AND THE DISTAL TIP OF THE COIL WIRE THAT SHOULD BE FUSED WITH THE CORE WIRE WAS NOTICED SEPARATED. THERE WAS NO REPORTED PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER NON-CORDIS GUIDEWIRE. THIS WAS A PEDIATRIC PERIPHERAL ARTERY (PA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CASE. AN UNKNOWN DIAGNOSTIC CATHETER WAS DELIVERED TO THE PA. THE .018 X 180CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WAS INSERTED, HOWEVER, THE POSITION OF THE DISTAL END AND THE SHAFT WAS OUT OF POSITION AND IT MIGHT HAVE BEEN STRETCHED. IT WAS CONFIRMED BY AN ANGIOGRAPHY WHICH WAS TAKEN BEFORE AN UNKNOWN PTA BALLOON CATHETER WAS INSERTED. THE WIRES WERE REMOVED FROM THE PATIENT. THE DEVICES WILL BE RETURNED FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719538 ↗
• InjuryJan 11, 2021Fracture; Fracture

  AS REPORTED, THE PHYSICIAN WAS USING A .18¿ 180CM STRAIGHT (ST) SV-5 PERIPHERAL STEERABLE GUIDEWIRE FOR FISTULA. HOWEVER, THE GUIDEWIRE WAS UP AGAINST THE WALL AND FELT LIKE IT GOT STUCK. THE PHYSICIAN ATTEMPTED TO REMOVE IT AND PART OF THE WIRE BROKE OFF IN THE PATIENT. THE PHYSICIAN WAS ABLE TO SNARE EVERYTHING AND COMPLETE THE PROCEDURE. THE USER WAS TRAINED WITH THE DEVICE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE INTENDED PROCEDURE WAS DIALYSIS ACCESS FISTULOGRAM AND THE TARGET LESION WAS CEPHALIC VEIN STENOSIS. THE VESSEL WAS 90 PERCENT STENOSED AND WAS NOT CALCIFIED NOR WAS THERE ANGULATION OR TORTUOSITY. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS NOT RESTERILIZED. THERE WERE NO ANOMALIES NOTED DURING PREP. THE PATIENT RECOVERED WITH NO ISSUES. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient; Stenosis

  MAUDE report 11149053 ↗
• InjuryJul 9, 2020Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED, DURING A RIGHT HEART CATHETERIZATION; THE TIP .018 180CM SHORT SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) HAD SNAPPED OFF WHEN THE DOCTOR TRIED TO PULL BACK THE DEVICE AS IT GOT STUCK IN THE PULMONARY ARTERY (PA). IT WAS THEN RETRIEVED BY A SNARE AND THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. THE PROCEDURE WAS COMPLETED ONCE THE WIRE WAS REMOVED, AS THERE WERE NO FURTHER ISSUES. NO PATIENT INJURY REPORTED. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE PRODUCT WAS PREPPED AND HANDLED AS PER THE INSTRUCTIONS FOR USE (IFU). THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE WIRE WAS NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS RE-SHAPED BY THE USER BY CURVING IT ON THE INSERTION DEVICE. ACCESS WAS OBTAINED VIA THE RIGHT INTERNAL JUGULAR VEIN AND THERE WAS NO RESISTANCE ENCOUNTERED AT THE ACCESS SITE. THERE WAS SOME TORTUOSITY OF THE PULMONARY VESSELS WHILE TRACKING THE WIRE BEFORE REACHING THE INTENDED SITE. THE WIRE DID NOT BECOME FIXED OR CAUGHT AT ANY TIME PRIOR TO THE EVENT. THE INTENDED VESSEL WAS THE PULMONARY ARTERY AND IT HAD NO CALCIFICATION, MILD TORTUOSITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10249906 ↗
• InjuryApr 16, 2018Fracture; Delamination; Fracture; Delamination

  DURING USE, IT WAS REPORTED THAT THE COATING OF THE DISTAL BLADE OF THE SV GUIDEWIRE FRAYED AND THE GUIDEWIRE SEPARATED INTO TWO. IT WAS IMPOSSIBLE TO REMOVE THIS THREAD SO IT WAS NECESSARY TO REMOVE THE PRODUCT WITH AN UNKNOWN SHEATH INTRODUCER IN A WAY SO TO NOT BREAK THE GUIDEWIRE IN THE ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7434472 ↗