HI-TORQUE EXTRA S'PORT 22225MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648079573), received between Nov 29, 2018 and Jan 3, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Product Quality Problem; Difficult to Remove; Use of Device Problem; Product Quality Problem; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF THE .014 SPORT EXTRA GUIDE WIRE (GW) FELT HEAVIER. THE TEFLON COATING FELT DIFFERENT AND THE COLOR LOOKED DIFFERENT THAN NORMAL. IT WAS ALSO NOTED THAT THE GW FELT TACKY AND IT WAS MORE DIFFICULT TO REMOVE BALLOONS AND STENTS WHEN EXCHANGING DEVICES, WHICH CAUSED THE GW TO BACK OUT OF THE VESSEL. THE PROCEDURE WAS COMPLETED WITH THE SAME GW, BUT THE GW HAD TO BE WIPED DOWN SEVERAL TIMES DURING USE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440282 ↗
• MalfunctionJan 3, 2024Product Quality Problem; Difficult to Remove; Use of Device Problem; Product Quality Problem; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED THAT DURING USE OF THE .014 SPORT EXTRA GUIDE WIRE (GW) FELT HEAVIER. THE TEFLON COATING FELT DIFFERENT AND THE COLOR LOOKED DIFFERENT THAN NORMAL. IT WAS ALSO NOTED THAT THE GW FELT TACKY AND IT WAS MORE DIFFICULT TO REMOVE BALLOONS AND STENTS WHEN EXCHANGING DEVICES, WHICH CAUSED THE GW TO BACK OUT OF THE VESSEL. THE PROCEDURE WAS COMPLETED WITH THE SAME GW, BUT THE GW HAD TO BE WIPED DOWN SEVERAL TIMES DURING USE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440248 ↗
• MalfunctionJul 19, 2021Material Deformation

  PATIENT WITH HISTORY OF HYPERTENSION, RECENT NAUSEA AND VOMITING WAS ADMITTED FOR A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOGRAM. WHEN PREPPING FOR THE PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE HI-TORQUE EXTRA SPORT GUIDE WIRE .014 STRAIGHT TIP 3.0 CM X 190 CM WAS DEFORMED PRIOR TO REMOVING IT FROM THE PACKAGE. DEVICE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12187762 ↗
• MalfunctionJul 28, 2020Material Twisted/Bent

  ELDERLY MALE TO EMERGENCY DEPARTMENT WITH ACTIVE CHEST PAIN. PRIOR TO INSERTION FOR THE HEART CATH, THE SPORT WIRE WAS OBSERVED BENT AND NOT USED. NO KNOWN HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331750 ↗
• MalfunctionDec 20, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, TREATING A TARGET LESION IN THE DIAGONAL ARTERY. THE 2.25 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO DIFFICULTY NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE STENT DELIVERY SYSTEM. HOWEVER, RESISTANCE WAS NOTED DURING REMOVAL OF THE EXTRA S'PORT GUIDE WIRE, AS THE GUIDE WIRE WAS CAUGHT ON THE DISTAL END OF THE STENT. THE GUIDE WIRE COILS STRETCHED INTO THE AORTA. A GUIDE LINER WAS ADVANCED INTO THE GUIDE CATHETER, IN AN ATTEMPT TO PUSH THE COILS BACK INTO THE VESSEL. A SECOND EXTRA S'PORT GUIDE WIRE WAS ADVANCED TO ASSIST REMOVAL OF THE FIRST GUIDE WIRE. THE SECOND GUIDE WIRE ALSO GOT STUCK ON THE STENT. IN THE ATTEMPT TO REMOVE BOTH GUIDE WIRES, THE STENT WAS EXPLANTED WITH THE GUIDE WIRES. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS DAMAGED DURING THE REMOVAL ATTEMPTS AND AN ADDITIONAL STENT WAS IMPLANTED. THE DIAGONAL ARTERY WAS NOT TREATED WITH ADDITIONAL STENTING AND NO VESSEL DAMAGE WAS NOTED FROM THE STENT EXPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508071 ↗
• InjuryDec 20, 2019Entrapment of Device; Stretched; Device Damaged by Another Device; Entrapment of Device; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY STENTING PROCEDURE, TREATING A TARGET LESION IN THE DIAGONAL ARTERY. THE 2.25 X 12 MM XIENCE SIERRA STENT WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO DIFFICULTY NOTED DURING ADVANCEMENT OR WITHDRAWAL OF THE STENT DELIVERY SYSTEM. HOWEVER, RESISTANCE WAS NOTED DURING REMOVAL OF THE EXTRA S'PORT GUIDE WIRE, AS THE GUIDE WIRE WAS CAUGHT ON THE DISTAL END OF THE STENT. THE GUIDE WIRE COILS STRETCHED INTO THE AORTA. A GUIDE LINER WAS ADVANCED INTO THE GUIDE CATHETER, IN AN ATTEMPT TO PUSH THE COILS BACK INTO THE VESSEL. A SECOND EXTRA S'PORT GUIDE WIRE WAS ADVANCED TO ASSIST REMOVAL OF THE FIRST GUIDE WIRE. THE SECOND GUIDE WIRE ALSO GOT STUCK ON THE STENT. IN THE ATTEMPT TO REMOVE BOTH GUIDE WIRES, THE STENT WAS EXPLANTED WITH THE GUIDE WIRES. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS DAMAGED DURING THE REMOVAL ATTEMPTS AND AN ADDITIONAL STENT WAS IMPLANTED. THE DIAGONAL ARTERY WAS NOT TREATED WITH ADDITIONAL STENTING AND NO VESSEL DAMAGE WAS NOTED FROM THE STENT EXPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508068 ↗
• MalfunctionMar 19, 2019Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE S'PORT GUIDE WIRE WAS ADVANCED TO THE MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. WHEN THE S'PORT GUIDE WIRE WAS BEING REMOVED FROM THE ANATOMY, RESISTANCE WAS MET WITH THE GUIDE CATHETER, THE OTHER GUIDE WIRE AND THE ULTRA STENT DELIVERY SYSTEM THAT WAS LOADED ON THE OTHER GUIDE WIRE. THE TIP OF THE S'PORT SEPARATED, BUT REMAINED INSIDE THE GUIDE CATHETER. WHEN THE GUIDE CATHETER WAS REMOVED, THE TIP OF THE S'PORT WAS REMOVED WITH THE GUIDE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432820 ↗
• InjuryNov 29, 2018Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED LESIONS IN THE LEFT MAIN (LM) AND OBTUSE MARGINAL (OM). A 3.5 GUIDING CATHETER WAS ADVANCED AND THE SPORT EXTRA GUIDE WIRE ADVANCED TO THE OM. A 3.50X8 MM XIENCE SIERRA STENT WAS PLACED IN THE LM AND A 2.25X18MM XIENCE SIERRA WAS PLACED IN THE OM. AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE HOWEVER IT WOULD NOT PULL FREE FROM THE DISTAL PORTION OF THE VESSEL AS IT WAS HUNG UP WITH THE STENT AND THE GUIDE WIRE SEPARATED AT THE JUNCTION/DISTAL END WHERE THE WIRE STARTS TO TURN SILVER. THE OM BECAME OCCLUDED AND THE PATIENT BECAME BRADYCARDIC. A TEMPORARY PACEMAKER WAS PLACED AND A SURGICAL CONSULT WAS CALLED. THE SURGEON DETERMINED THERE WAS NO NEED TO REMOVE THE GUIDE WIRE AS IT WAS STUCK IN THE DISTAL PORTION OF THE VESSEL AND DID NOT SEEM LIKE IT WOULD EMBOLIZE. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MEDICALLY MONITORED. NO FORCE WAS APPLIED DURING REMOVAL OF THE GUIDE WIRE. THE GUIDE WIRE WAS NOT JAILED BENEATH THE STENT

  Patient problems: Bradycardia; Occlusion; Vessel Or Plaque, Device Embedded In

  MAUDE report 8117925 ↗