SV WIRE 503558XRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705032056069), received between Nov 18, 2016 and Sep 15, 2026 — classified as 6 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779047 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  As reported, there was damage to two .018 300cm SV-5 straight tip guidewires. The guidewire was fractured at the distal tip, and the damage was observed after use inside the patient. The guidewires did not separate into two pieces. Both guidewires fractured but remained intact without separated pieces. The fractures resulted in the guidewires failing to provide the support needed to cross the lesion. The guidewire was replaced with a non-Cordis .035 guidewire. There were no reported injuries to the patient. The devices were stored according to the instructions for use (IFU). No damage to the device packaging or guidewire hoops was reported prior to opening. The wires were not removed from their dispensers by the distal floppy end; they were removed from the proximal portion at the catheter hub. The devices will not be returned for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778872 ↗
• MalfunctionJul 9, 2026Fracture

  AS REPORTED, DURING USE OF THE THREE .018 SV SHORT 300CM SV GUIDEWIRES, THAT THE DISTAL TIP PORTION OF THE GUIDEWIRE WAS TORN AND DETACHED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762070 ↗
• MalfunctionJul 9, 2026Fracture

  AS REPORTED, DURING USE OF THE THREE .018 SV SHORT 300CM SV GUIDEWIRES, THAT THE DISTAL TIP PORTION OF THE GUIDEWIRE WAS TORN AND DETACHED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762065 ↗
• MalfunctionApr 30, 2024Fracture; Fracture

  AS REPORTED, WHEN REMOVING THAT .018 SV SHORT 300CM WIRE DURING AN ANGIO CASE, THE TIP SEPARATED FROM THE REST OF WIRE. IT STAYED ATTACHED TO THE BASE OF WIRE BY A VERY THIN STRAND. THE TEAM WAS ABLE TO REMOVE THE ENTIRE WIRE WITHOUT LOSING THE TIP THAT SEPARATED. THE FACILITY HAD TWO MORE BOXES OF FIVE WITH THE SAME LOT NUMBER THAT THEY (THE FACILITY) PULLED FROM THE SHELF. THERE WAS NO DAMAGE TO THE PACKAGING OF THE DEVICE. THERE WERE NO ANOMALIES NOTED PRIOR TO REMOVING THE DEVICE FROM THE PACKAGING. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE HOOP. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED PER THE IFU. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. EXCESS FORCE WAS NOT APPLIED DURING INSERTION. THE LESION WAS IN THE POPLITEAL ARTERY. THE FEMORAL ARTERY WAS USED FOR ACCESS. THE DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215562 ↗
• InjuryJun 23, 2023Fracture; Fracture

  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 17190661 ↗
• MalfunctionMay 15, 2023Fracture; Fracture

  AS REPORTED, THE COIL WIRE PART (SOFT TIP TO HARD TIP CONNECTION) OF A .018 SV STEERABLE 300CM STRAIGHT GUIDEWIRE HAS BEEN STRETCHED AND BROKEN "FREQUENTLY LATELY." THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED IN AN APPROPRIATE CABINET, HANDLED, AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE INTENDED TARGET LESION WAS IN A CHILD¿S CARDIAC ARTERY. THE DEVICE WAS FLUSHED PRIOR TO USE. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: A FRACTURED/SEPARATED CONDITION WAS OBSERVED ON THE CORE WIRE WITH THE COILED WIRE NOTED TO BE ATTACHED TO THE UNIT. THE SEPARATED PORTION OF THE WIRE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16932323 ↗
• MalfunctionMay 8, 2023Fracture; Fracture

  AS REPORTED, THE DISTAL TIP OF A .018 5 CM 300 CM STRAIGHT TIP SV STEERABLE GUIDEWIRE WAS FOUND FRACTURED AFTER REMOVAL. APPROXIMATELY 10-15 MM FROM THE DISTAL END THE DEVICE SEPARATED. A NON-CORDIS .018 GLIDE WIRE WAS ADVANCED, AND A NON-CORDIS STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN REMOVED SOME OF THE GUIDEWIRE VIA AN UNKNOWN NON-CORDIS MICRO SNARE. THE REMAINING PORTION OF THE GUIDEWIRE WAS TRAPPED BETWEEN A NON-CORDIS STENT AND THE ARTERY WALL AS THEY INTENDED ON USING THAT DEVICE FOR PATIENT TREATMENT. NO FUTURE COMPLICATIONS WERE NOTED. A 7F SHEATH WAS ADVANCED INTO PLACE. AFTER CROSSING THE CAROTID ARTERY WITH THE DEVICE, A NON-CORDIS STENT WAS ADVANCED UNSUCCESSFULLY. THEN A .018 NON-CORDIS GLIDE WIRE WAS ADVANCED, AND A NON-CORDIS WAS STENT WAS SUCCESSFULLY DEPLOYED. THE WIRE WAS NOT REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). THE GUIDEWIRE MANIPULATION/TORQUING WAS PERFORMED UNDER FLUOROSCOPIC GUIDANCE. THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING OR WITHDRAWING THE GUIDEWIRE. THE GUIDEWIRE DID NOT BECOME ENTRAPPED AT ANY POINT IN THE PROCEDURE. THE DEVICE WAS NOT BEING USED ON HIGHLY TOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885046 ↗
• InjuryMay 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE DISTAL END OF THE 0.018" 300CM SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) GOT TRAPPED IN THE PULMONARY ARTERY (PA). THE PHYSICIAN ATTEMPTED TO REMOVE THE COMPLAINT DEVICE AS TENSION WAS APPLIED BUT THE COMPLAINT DEVICE GOT SEPARATED. THE PHYSICIAN ATTEMPTED TO REMOVE THE SEPARATED COMPLAINT DEVICE BY USING A SNARE CATHETER, BUT THE SNARE CATHETER ALSO GOT TRAPPED IN THE PULMONARY ARTERY AND THE SNARE WIRE PART GOT SEPARATED. THE DISTAL END OF THE COMPLAINT DEVICE AND THE SNARE WIRE PART WERE UNABLE TO BE REMOVED AND THE PROCEDURE WAS TERMINATED. THIS WAS A PEDIATRIC PULMONARY ARTERY (PA) EXPANSION CASE. THERE WERE 2 COMPLAINT DEVICES USED FOR PA DILATATION. ON THE LEFT PA A 0.18 SV SHORT GUIDEWIRE 180 CM LOT 35264005 WAS USED BUT BECAME UNRAVELED BUT WAS RETRIEVED; A SNARE WAS USED TO GRAB THE DISTAL PART OF THE DEVICE. (REFER TO (B)(4)). A 0.018" 300CM SV SHORT PERIPHERAL STEERABLE GUIDEWIRE LOT 35265675 WAS USED ON THE RIGHT PULMONARY ARTERY. SINCE THE FIRST COMPLAINT DEVICE WAS UNRAVELED, THE PHYSICIAN USED THIS TO EXPAND THE PA BALLOON. AFTER COMPLETION OF DILATION AND CONFIRMATION ANGIOGRAPHY AFTER REMOVAL OF THE BALLOON, THERE WAS AN INTENSIVE RESISTANCE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875295 ↗
• MalfunctionApr 3, 2023Fracture; Fracture

  AS REPORTED, A STRAIGHT SHORT 0.018" X 300CM, 5CM DISTAL TAPER SV STEERABLE GUIDEWIRE BROKE OFF, AS IT "SHEARED APART" INSIDE THE NON-CORDIS SUPPORT CATHETER WHEN PULLING THE WIRE OUT. THERE WERE NO REPORTS OF PATIENT INJURY. THE WIRE WAS REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END. THE DEVICE WAS NOT USED FOR A COMPLETE TOTAL OCCLUSION (CTO). GUIDEWIRE MANIPULATION AND TORQUING WAS PERFORMED UNDER FLUOROSCOPIC GUIDANCE. RESISTANCE WAS ENCOUNTERED WHILE WITHDRAWING THE GUIDEWIRE. THE GUIDEWIRE BECAME ENTRAPPED AT ONE POINT IN THE PROCEDURE. THE DEVICE WAS USED ON HIGHLY TORTUROUS VASCULATURE BUT WAS NOT USED ON SMALL SIDE BRANCHES. THE GUIDEWIRE WAS NOT EXPOSED TO A METAL DEVICE. THERE WAS NO CALCIFICATION, ACUTE ANGULATION, OR BIFURCATION OF THE PATIENT¿S VESSEL. TORQUE CONTROL/TIP RESPONSE WAS COMPROMISED WHILE USING THE GUIDEWIRE SINCE THE WIRE "SHREDDED" AT THE END. THE PROXIMAL TIP OF THE DEVICE SEPARATED. THE USER WAS ABLE TO RETRIEVE THE SEGMENT BY ¿WIGGLING IT OUT¿. THE DEVICE WAS SEPARATED BUT ¿NOT COMPLETELY¿. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668053 ↗
• MalfunctionFeb 21, 2023Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL TIP OF AN SV-5 0.018 300CM GUIDEWIRE FRAYS EASILY WHILE BEING MANEUVERED AND LOSES ITS CHARACTERISTICS. AS A RESULT, A NON-CORDIS .014 GUIDEWIRE WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT. THIS WAS DURING A PROCEDURE TO TREAT A 50% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD MILD CALCIFICATION BUT NO TORTUOSITY. THIS WAS DURING A PROCEDURE TO TREAT A 50% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD MILD CALCIFICATION BUT NO TORTUOSITY. THERE WERE NO ACUTE ANGLES OR BIFURCATIONS PRESENT AT THE TARGET LESION. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE PRIOR TO USE. THERE WAS NEVER AN ATTEMPT TO SHAPE THE DISTAL TIP OF THE GUIDEWIRE AND THE GUIDEWIRE WAS MANIPULATED UNDER FLUOROSCOPY. THE DEVICE WAS ABLE TO BE REMOVED EASILY AND REMAINED IN ONE PIECE DURING ITS REMOVAL. THE DEVICE WAS NOT RETURNED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414379 ↗
• MalfunctionJun 20, 2022Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, THE WIRE TIP OF AN SV-5 STEERABLE GUIDEWIRE (PGW .018 SV SHORT 300CM ST) CAME OUT OF PACKAGE FRAYED AND UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT USED IN THE PATIENT THE PRODUCT WAS STORED AS PER LABELING. THE DAMAGE WAS NOTICED DURING PREP. THE TIP OF THE WIRE WAS STRETCHED AND UNRAVELED WHEN THE DEVICE WAS TAKEN OUT OF THE THE PACKAGE. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE NOR ANY DIFFICULTY ENCOUNTERED REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14745870 ↗
• MalfunctionMay 4, 2022Fracture; Fracture

  AS REPORTED, DURING PREPARATION THE PROXIMAL END OF A 0.018 300CM STRAIGHT SVP 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 AND THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PRODUCT EVALUATION REVEALED A SEPARATED/FRACTURED CONDITION ON THE DISTAL TIP OF THE CORE AND COIL WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278312 ↗
• MalfunctionApr 14, 2022Break; Device Dislodged or Dislocated

  DURING THE PROCEDURE, AN SV5 WIRE WAS USED VIA THE RIGHT INTERNAL JUGULAR VEIN, AND A PIECE OF THE WIRE BROKE AND DISLODGED ITSELF IN A DISTAL BRANCH OF THE RIGHT PULMONARY ARTERY. PATIENT¿S VITAL SIGNS REMAINED STABLE DURING THE PROCEDURE. THE DR. (DOCTOR) ATTEMPTED TO REMOVE THE BROKEN PIECE OF WIRE MULTIPLE TIMES WITH DIFFERENT SNARING DEVICES WITHOUT SUCCESS, AT WHICH POINT, THE DR. DECIDED THE RISK OF REMOVAL WILL RISK HARM TO THE PATIENT IN THE LOCATION THAT IT WAS IN. THERE WAS NO POSSIBILITY OF DEVICE MOVING ELSEWHERE IN THE BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14110731 ↗
• MalfunctionFeb 23, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED, THE PHYSICIAN PLACED A SV SHORT 0.018" X 300CM PERIPHERAL STEERABLE GUIDEWIRE IN THE LEFT PULMONARY ARTERY (PA) BUT WHEN IT WAS ATTEMPTED TO BE REMOVED THROUGH THE SHEATH IN THE GROIN, IT WAS NOT COMING OUT. THE DIFFICULTY WAS IN REMOVING THE WIRE FROM THE PA. THE PHYSICIAN WAS ABLE TO REMOVE IT BUT THE WIRE HAD UNRAVELED. ALL OF THE WIRE WAS REMOVED AND REMOVAL CONFIRMED WITH FLUOROSCOPY. THE WIRE WAS REMOVED AND THE PROCEDURE CONTINUED AS NORMAL. NO PATIENT INJURY REPORTED. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583314 ↗
• MalfunctionDec 2, 2021Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL AREA OF A .018¿ STRAIGHT 300CM SV SHORT PERIPHERAL STEERABLE GUIDEWIRE WAS FRAYED. THEREFORE, ANOTHER GUIDEWIRE WAS OPENED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12917390 ↗
• MalfunctionNov 17, 2021Fracture; Fracture

  AS REPORTED, WHEN PASSING A .018¿ SV SHORT 300CM STRAIGHT PERIPHERAL STEERABLE GUIDEWIRE THROUGH AN UNKNOWN BALLOON CATHETER, THE GUIDEWIRE ¿FELL APART¿. THE DEVICE THAT "FELL APART" MEANT THE DEVICE BROKE IN TWO PARTS BEFORE IT WAS USED IN THE PATIENT AND HAD NO CONTACT WITH THE PATIENT . ANOTHER SV SHORT PERIPHERAL STEERABLE GUIDEWIRE WITH THE SAME SIZE WAS OPENED AND THE GUIDE WIRE BROKE IN TWO PARTS. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICES DID NOT SEPARATE INSIDE THE PATIENT. ALL THE PROBLEMS WERE NOTED BEFORE INSERTING THE DEVICES INTO THE PATIENT. THE EVENT OCCURRED ON PREPARATION OF THE MATERIAL. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED ON PREPARATION OF THE MATERIAL. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY. (SFA)THE ACCESS SITE WAS FEMORAL WITH A UNKNOWN 6F SHEATH. THE DEVICE WAS PREPPED PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. A CONTRALATERAL APPROACH WAS USED. THE VESSEL CHARACTERISTICS AT TARGET SITE, SHOWED LIGHT CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827976 ↗
• MalfunctionNov 16, 2021Fracture; Fracture

  AS REPORTED, WHEN PASSING A .018¿ SV SHORT 300CM STRAIGHT PERIPHERAL STEERABLE GUIDEWIRE THROUGH AN UNKNOWN BALLOON CATHETER, THE GUIDEWIRE ¿FELL APART¿. THE DEVICE THAT "FELL APART" MEANT THE DEVICE BROKE IN TWO PARTS BEFORE IT WAS USED IN THE PATIENT AND HAD NO CONTACT WITH THE PATIENT . ANOTHER SV SHORT PERIPHERAL STEERABLE GUIDEWIRE WITH THE SAME SIZE WAS OPENED AND THE GUIDE WIRE BROKE IN TWO PARTS. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICES DID NOT SEPARATE INSIDE THE PATIENT. ALL THE PROBLEMS WERE NOTED BEFORE INSERTING THE DEVICES INTO THE PATIENT. THE EVENT OCCURRED ON PREPARATION OF THE MATERIAL. THERE WAS NO REPORTED PATIENT INJURY. THE EVENT OCCURRED ON PREPARATION OF THE MATERIAL. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY. (SFA)THE ACCESS SITE WAS FEMORAL WITH A UNKNOWN 6F SHEATH. THE DEVICE WAS PREPPED PER THE INSTRUCTION FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. A CONTRALATERAL APPROACH WAS USED. THE VESSEL CHARACTERISTICS AT TARGET SITE, SHOWED LIGHT CALCIFICATION AND NO TORTUOSITY. THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THERE WERE NO ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821608 ↗
• MalfunctionSep 28, 2021Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, THE TWO (2) .018 X 300CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WERE FRAYED INSIDE THE PATIENT. THERE WAS DIFFICULTY TRACKING THE WIRES THROUGH THE VESSEL OR LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. AN ADDITIONAL NON-STERILE DEVICE WAS RETURNED FOR EVALUATION RELATED TO THE EVENT. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE INTENDED PROCEDURE WAS A PERIPHERAL ANGIOGRAM. 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 INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). 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 RESTERILIZED WHEN REMOVED FROM THE PATIENT. THE EVENT OCCURRED WHILE CROSSING THE LESION. THE WIRE TIP WAS VISIBLE ON F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538792 ↗
• MalfunctionSep 22, 2021Material Frayed; Material Frayed

  AS REPORTED, THE .018¿ 300CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) FRAYED ON THE DISTAL AREA AGAIN. A NEW SUPPORT GUIDEWIRE (UNKNOWN) WAS OPENED AND USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512196 ↗
• MalfunctionSep 2, 2021Fracture; Material Frayed; Fracture; Material Frayed

  AS REPORTED, A .018¿ 300CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) FRAYED ON ITS DISTAL AREA. A NEW SUPPORT GUIDEWIRE (UNKNOWN) WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414220 ↗
• InjuryAug 26, 2021Fracture; Material Separation; Fracture; Material Separation

  DURING THE PROCEDURE, WHEN PROBING A PULMONARY VEIN WITH A .018¿ 300CM SHORT SV STRAIGHT PERIPHERAL STEERABLE GUIDEWIRE, A LOOP FORMED AT THE TIP WHICH IS NORMAL. WHEN THE WIRE WAS PULLED BACK, THE TIP OF THE WIRE WAS BROKEN. THE ¿SHEATH¿ OF THE WIRE HAD PARTIALLY COME OFF. THE DISTAL TIP OF THE WIRE INCLUDING THE X-RAY MARKINGS HAVE REMAINED IN THE VESSEL. PARTS OF THE SHEATHING OF THE WIRE HAVE ALSO REMAINED IN THE VESSEL. THE REMAINING PARTS HAD TO BE REMOVED WITH A SNARE, WHICH WAS SUCCESSFUL. THE PHYSICIAN CONTINUED WORKING WITH ANOTHER NON-CORDIS GUIDEWIRE AND THE PATIENT IS FINE. THE PRODUCT 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 LOOPED WHILE BEING USED BUT DID NOT KINK. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12369802 ↗
• MalfunctionAug 10, 2021Material Frayed; Material Frayed

  AS REPORTED, THE TWO (2) .018 X 300CM STRAIGHT TIP SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) WERE FRAYED INSIDE THE PATIENT. THERE WAS DIFFICULTY TRACKING THE WIRES THROUGH THE VESSEL OR LESION. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE USED IN PATIENT. THE DEVICES WERE STORED AS PER LABELING AND OPENED IN STERILE FILED. THE INTENDED PROCEDURE WAS A PERIPHERAL ANGIOGRAM. 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 INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE TARGET SITE WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS FEMORAL. THE LESION WAS MODERATELY CALCIFIED. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). 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 RESTERILIZED WHEN REMOVED FROM THE PATIENT. THE EVENT OCCURRED WHILE CROSSING THE LESION. THE WIRE TIP WAS VISIBLE ON FLUORO THROUGHOUT THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION BETWEEN THE WIRE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299346 ↗
• InjuryApr 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF THE 0.018" 300CM STRAIGHT (ST) SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) BROKE IN PATIENT. THE WIRE WAS SUCCESSFULLY RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY. A V-18 WIRE WAS USED INSTEAD OF SV-5. THE TARGET LESION WAS MILDLY STENOSED. THE DEVICE WAS STORED PER LABELLING AND OPENED IN STERILE FIELD. THE PRODUCTS WERE STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE WERE REMOVED FROM THE SHARP END TO THE RUBBER STOPPER AND PUSHED WIRE THROUGH WIRE HOUSE. THE WIRES WERE NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WAS ADVANCED WITHIN A 4 FR NON-TAPERED ANGLE GLIDE CATHETER IN THE RIGHT LOWER PULMONARY VEIN AND ANCHORED WITHIN A SMALL BRANCH. THE WIRE WAS ADVANCED SMOOTHLY WITHOUT ANY FORCE. THE WIRE TIP WAS CURVED WITHIN THE SMALL VESSEL AS USUAL. HOWEVER, THERE WAS SIGNIFICANT RESISTANCE WHEN ATTEMPTING TO REMOVE THE WIRE BACK IN TO THE CATHETER. WE NEEDED TO REMOVE THE WIRE BY PULLING BACK THE CATHETER ALMOST TO THE PULMONARY VEIN OSTIUM AND SLOWLY PULLING WIRE BACK WITH ¿SMALL SHAKING MOTION¿ UNTIL THE WIRE WAS FREE. THE SV WIRE WAS ONLY USED FOR ONE LESION, HOWEVER, THE WIRE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683436 ↗
• InjuryMar 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE TIP OF THE 0.018" 300CM STRAIGHT (ST) SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) BROKE OFF WHILE IN PATIENT. THE TIP WAS SNARED. THERE WAS NO PATIENT INJURY, THE PATIENT WAS DISCHARGED. THE WIRE AND CATHETER WERE REMOVED. PATIENT WAS BROUGHT BACK FOR STENTING. THE TARGET LESION IS THE RIGHT ILIAC VEIN WITH TOTAL CHRONIC OCCLUSION. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO UNUSUAL FORCED USED AFTER THE PHYSICIAN PULLED BACK ON THE WIRE. THE WIRE DID 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. A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WAS NOT USED TO RECANNULIZE THE VESSEL. THERE WAS NO DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRES BEHAVED ¿NORMALLY¿. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THE ACCOUNT THREW PRODUCT AWAY BY ACCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11585547 ↗