SV WIRE 503658XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032056083), received between Mar 18, 2021 and Jul 14, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2022Fracture; Fracture

  AS REPORTED, WHEN THE PHYSICIAN WAS USING A 0.018" 300CM STRAIGHT (ST) TIP SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) FOR A RIGHT HEART CATHETERIZATION, THE WIRE SEEMED TO BE CATCHING WHEN TRYING TO REMOVE IT FROM A NON-NON-CORDIS SWANZ GANZ CATHETER. UPON REMOVAL THE WIRE WAS UNRAVELED. THERE WAS NO REPORTED PATIENT INJURY OR COMPLICATIONS. THE PRODUCT WAS STORED AS PER LABELING. THE DEVICE WAS BEING USED IN A RIGHT HEART CATHETERIZATION USING A FEMORAL APPROACH. THE DEVICE WAS NOT BEING USED FOR A CHRONIC TOTAL OCCLUSION. THERE WERE NO ANOMALIES NOTED WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE NOR DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE OTHER DEVICES USED DID NOT SHOW ANY SIGNS OF DAMAGE AFTER THE PROCEDURE; JUST THE THE DISTAL END OF THE WIRE WAS UNRAVELED. NO EXCESS FORCE WAS USED DURING THE PROCEDURE. PRODUCT EVALUATION REVEALED THE GUIDEWIRE IS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15012728 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  AS REPORTED, THE 0.018" 300CM STRAIGHT (ST) TIP SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) FELL APART AND BECAME USELESS DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW. IMAGE 1 (SRTAB.JPG) SHOWED AN OPENED POUCH OF AN SV8 GUIDE WIRE LOT # 35263141 WITH WHAT APPEARS TO BE A GUIDE WIRE, AND THE DISTAL TIP APPEARS TO BE DAMAGED. IMAGE 2 (GUIA STAB.JPG) SHOWED THE DISTAL TIP OF A GUIDE WIRE IN CLOSE UP. THE TIP APPEARS TO BE UNRAVELED FOR APPROXIMATELY 1-1.5 CM, WITH THE COIL UNWOUND FROM A CENTRAL CORE. THE LESION CALCIFICATION WAS MODERATE, WITH NO VESSEL TORTUOSITY AND THIRTY-PER-CENT STENOSIS. THE PRODUCT BEING USED IN A MALE PATIENT FOR A REVASCULARIZATION PROCEDURE USING A FEMORAL APPROACH. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE AND NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THE DEVICE WAS PREPPED PER THE IFU AND THERE WERE NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. NEITHER THE DEVICE NOR THE OTHER DEVICES USED WITH THE PRODUCT KINKED OR BENT AT ANY TIME. THE PRODUCT WAS NOT RESTERILIZED AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14938813 ↗
• MalfunctionNov 11, 2021Material Frayed; Material Frayed

  AS REPORTED, THE DISTAL AREA OF A .018¿ SV 300CM STRAIGHT (ST) PERIPHERAL STEERABLE GUIDEWIRE WAS FRAYED. THEREFORE, ANOTHER GUIDEWIRE WAS OPENED 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 12798907 ↗
• MalfunctionMar 29, 2021Material Frayed; Material Frayed

  AS REPORTED, THE 0.018" 300CM STRAIGHT (ST) TIP SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) FRAYED ON THE DISTAL AREA. BECAUSE OF THIS SITUATION, THE DEVICE DIDN´T PROGRESS IN THE SUPPORT CATHETER (UNKNOWN). IT WAS NECESSARY TO USE AN EXTRA HYDROPHILIC WIRE (0.018, 30 CM). THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11582619 ↗
• MalfunctionMar 18, 2021Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  AS REPORTED, THE .018¿ 180CM STRAIGHT (ST) SV PERIPHERAL STEERABLE GUIDEWIRE (PGW) LOST A HYDROPHILIA AND THERE WAS AN EXPOSURE OF THE ¿GUIDE SOUL¿.. AS PER THE SALES REP¿ GUIDE SOUL¿ IS THE INTERNAL WIRE BELOW THE HYDROPHILIC LAYER, WHERE IT GIVES US TORQUE, RIGIDITY AND SUSTAINABILITY DURING THE SURGERY. UNFORTUNATELY, THIS PROBLEM IS FREQUENTLY WITH THIS MATERIAL¿. THE PRODUCT WAS NOT RESTERILIZED. THE PRODUCT WAS STORED AND OPENED AS PER THE INSTRUCTIONS FOR USE . 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. THE WIRE WAS NOT USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. THE PATIENT IS STABLE THE PHYSICIAN USED A NEW UNKNOWN GUIDEWIRE TO COMPLETE 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 11515893 ↗