HI-TORQUE VERSATURN 1013317Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 08717648198434), received between Oct 19, 2016 and Sep 11, 2026 — classified as 28 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (68 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Difficult to Remove; Material Separation; Stretched

  Patient problems: Foreign Body In Patient

  MAUDE report 50737134 ↗
• MalfunctionJul 22, 2026Difficult to Remove; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904856 ↗
• MalfunctionJul 20, 2026Break; Stretched; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25875606 ↗
• InjuryJul 17, 2026Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY LESION WITH 90% STENOSIS. A 190 CM 014 HT VERSATURN F GUIDE WIRE WAS ADVANCED. HOWEVER, IT WAS UNABLE TO REACH THE LESION AND BECAME STUCK IN THE ANATOMY. A MICROCATHETER WAS USED TO REMOVE THE GUIDE WIRE. AN ADDITIONAL NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856525 ↗
• MalfunctionJan 27, 2026Peeled/Delaminated; Material Too Rigid or Stiff; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH 90% STENOSIS AND NOTED TORTUOSITY AND CALCIFICATION. THE VERSATURN GUIDE WIRE WAS USED AND THE TIP BECAME DEFORMED AFTER SHAPING. THE SURFACE COATING WAS NOTED TO BE SHEDDED, THERE WAS STIFFNESS AND FRICTION NOTED WITH THE ANATOMY AS WELL. THE DEVICE WAS REPLACED WITH AN UNSPECIFIED WIRE. THERE WERE NO ADVERSE EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193477 ↗
• MalfunctionJan 14, 2026Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE VERSATURN GUIDE WIRE TIP BECAME STUCK IN THE ANATOMY DURING REMOVAL. THE WIRE WAS REMOVED INDEPENDENTLY, WITHOUT ANY FRACTURE OR SEPARATION. A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073166 ↗
• MalfunctionJan 2, 2026Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS NOTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 70% STENOSED. UPON REMOVAL OF THE HT VERSATURN GUIDE WIRE, RESISTANCE WAS NOTED WITH AN UNSPECIFIED STENT. FORCE WAS APPLIED TO REMOVE THE GUIDE WIRE. UPON REMOVAL, THE GUIDE WIRE TIP WAS NOTED TO UNRAVEL AND THE GUIDE WIRE COILS STRETCHED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949920 ↗
• MalfunctionJan 2, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. THE 190CM 014 HT VERSATURN GUIDEWIRE WAS ENTRAPPED IN THE CALCIFIED LESION MAKING IT DIFFICULT TO REMOVE; HOWEVER, WAS WITHDRAWN WITH FORCE. UPON REMOVAL, THE TIP OF THE GUIDEWIRE WAS NOTED TO BE SPIRAL-SHAPED/WAVY AND COULD NOT BE RE-SHAPED. A NEW VERSATURN GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946117 ↗
• MalfunctionDec 16, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT WHEN THE TWO VERSATURN GUIDE WIRES WERE REMOVED FROM THE PACKAGING, AN ABNORMAL AREA WAS NOTED APPROXIMATELY 45MM FROM THE TIP, THE COILS WERE BROKEN. THEREFORE THE GUIDE WIRES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS RECEIVED. A PICTURE OF THE GUIDE WIRES NOTED THE TIP COILS WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815810 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE TWO VERSATURN GUIDE WIRES WERE REMOVED FROM THE PACKAGING, AN ABNORMAL AREA WAS NOTED APPROXIMATELY 45MM FROM THE TIP, THE COILS WERE BROKEN. THEREFORE, THE GUIDE WIRES WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS RECEIVED. A PICTURE OF THE GUIDE WIRES NOTED THE TIP COILS WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815776 ↗
• MalfunctionNov 13, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE .014 HT VERSATURN GUIDE WIRE MET RESISTANCE WITH A PREVIOUSLY IMPLANTED STENT WHEN ATTEMPTING TO ADVANCED. DURING REMOVAL THE TIP OF THE GUIDE WIRE SNAGGED ON IMPLANTED STENT AND BECAME KINKED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547822 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, THE TIP OF A 014 HI-TORQUE (HT) VERSATURN GUIDEWIRE WAS FOUND BROKEN. A NEW HT VERSATURN GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23528173 ↗
• MalfunctionSep 12, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE VERSATURN GUIDE WIRE WAS USED WITH A BALLOON CATHETER HOWEVER BECAME STUCK AND COULD NOT BE REMOVED. THE GUIDE WIRE WAS REMOVED AND THE PROCEDURE WAS CONTINUED USING ANOTHER GUIDE WIRE. THIS CAUSED A DELAY IN THE PROCEDURE WITH PATIENT DISCOMFORT; HOWEVER AS THE DELAY DID NOT RESULT IN A SERIOUS ADVERSE EFFECT, THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23039042 ↗
• MalfunctionSep 10, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. ONCE AT THE LESION, THE 014 HI-TORQUE VERSATURN GUIDEWIRE GOT CAUGHT ON A PREVIOUSLY DEPLOYED STENT AND THE GUIDEWIRE TIP KINKED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021985 ↗
• InjuryAug 14, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A POSTERIOR DESCENDING ARTERY (PDA) AND RIGHT CORONARY ARTERY (RCA). THE 3.5X38MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE PDA AND STANDARD POST-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. THE VERSATURN GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED TO THE RCA; HOWEVER, THE GUIDE WIRE BECAME STUCK WITH THE IMPLANTED XIENCE SKYPOINT. WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE, IT WAS STILL STUCK WITH THE STENT AND EXTRA FORCE WAS USED TO PULL IT. THE TIP SEPARATED AND REMAINS FREE-FLOATING IN THE ANATOMY. THE IMPLANTED XIENCE SKYPOINT WAS NOTED TO STRETCH A LITTLE, BUT REMAINED SUCCESSFULLY IMPLANTED. NO OTHER DEVICES WERE USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22809423 ↗
• MalfunctionJul 21, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 014 HT VERSATURN GUIDE WIRE (GW) WAS USED IN THE PROCEDURE; HOWEVER, THE GW WAS REMOVED WITH RESISTANCE. IT WAS THEN NOTED THAT THE GW CORE SEPARATED AND THE COILS UNRAVELED BUT REMAINED INTACT. 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 22558619 ↗
• InjuryJul 21, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DIAGONAL BRANCH. A 190CM 014 VERSATURN GUIDE WIRE WAS ADVANCED WITH RESISTANCE INTO THE LESION FOR DIAGONAL BRANCH PROTECTION. AFTER IMPLANTING A NON-ABBOTT STENT IN THE FRONT DESCENDING BRANCH, IT WAS NOTED THAT THE GUIDE WIRE WAS JAILED BEHIND THE STENT. DURING REMOVAL, RESISTANCE WAS NOTED AND THE TIP OF THE GUIDE WIRE SEPARATED. THE TIP WAS LEFT ENTRAPPED BETWEEN THE IMPLANTED STENT AND THE VASCULAR WALL. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22556396 ↗
• MalfunctionJul 17, 2025Break; Difficult to Remove; Material Separation; Break; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VERSATURN GUIDE WIRE (GW) WAS PLACED IN THE DIAGONAL ARTERY FOR PROTECTION [SUPPORT] DURING THE PROCEDURE. HOWEVER, DURING REMOVAL OF THE GW, RESISTANCE WAS NOTED WITH A PREVIOUSLY UNSPECIFIED IMPLANTED STENT AND THE RADIOPAQUE TIP BECAME SEPARATED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22536583 ↗
• InjuryJun 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE HI-TORQUE (HT) VERSATURN GUIDE WIRE WAS PLACED IN DIAGONAL OF THE MAIN LAD. DURING REMOVAL OF THE GUIDEWIRE, THE TIP SPRUNG THEN SEPARATED AND REMAINED FREE-FLOATING IN THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS POINT AND IT IS UNKNOWN IF ANY TREATMENT WAS GIVEN TO THE PATIENT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22169603 ↗
• MalfunctionApr 28, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED INTO THE ANATOMY AND A BALLOON CATHETER WAS ADVANCED OVER THE WIRE HOWEVER IT BECAME STUCK. THE GUIDE WIRE AND BALLOON CATHETER WERE REMOVED TOGETHER. ANOTHER GUIDE WIRE WAS USED WITH THE SAME BALLOON CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918708 ↗
• InjuryApr 25, 2025Entrapment of Device; Stretched; Entrapment of Device; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE VERSATURN GUIDE WIRE WAS USED IN THE PROCEDURE BUT IT WAS NOTED DURING REMOVAL THAT THERE WAS RESISTANCE DUE TO A STENT. THE TIP COILS WERE STUCK IN THE MESH OF THE STENT. AFTER MANY ATTEMPTS, A MICROCATHETER WAS USED TO REMOVE THE GUIDE WIRE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912086 ↗
• MalfunctionApr 16, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. DURING REMOVAL FROM THE ANATOMY OF THE .014 HT VERSATURN GUIDE WIRE RESISTANCE WAS FELT WITH THE UNSPECIFIED GUIDE CATHETER AND TIP COILS STRETCHED AND SEPARATED FROM THE CORE; HOWEVER, THE GUIDE WIRE REMAINED IN ONE PIECE. AFTER SEVERAL ATTEMPTS THE GUIDE WIRE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21851036 ↗
• MalfunctionApr 1, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED AND A BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE HOWEVER BECAME STUCK ON THE DISTAL END OF THE GUIDE WIRE AND COULD NOT BE RETRACTED. AFTER MULTIPLE ANGLE ROTATIONS AND GENTLE RETRACTION, THE BALLOON AND GUIDEWIRE WERE WITHDRAWN TOGETHER. A NEW GUIDEWIRE WAS THEN USED TO RE-ENTER THE CORONARY ARTERY AND COMPLETE THE SURGERY. BLEEDING WAS NOTED AT THE ACCESS SITE THEREFORE MANUAL COMPRESSION WAS USED TO STOP THE BLEEDING. PER THE PHYSICIAN, THE VERSATURN GUIDE WIRE DID NOT CAUSE OR CONTRIBUTE TO THE BLEEDING. ALTHOUGH THERE WAS A REPORT DELAY IN THE PROCEDURE, THERE WERE NO ADVERSE PATIENT EFFECTS THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21743482 ↗
• MalfunctionApr 1, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED AND A BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE HOWEVER BECAME STUCK ON THE DISTAL END OF THE GUIDE WIRE AND COULD NOT BE RETRACTED. AFTER MULTIPLE ANGLE ROTATIONS AND GENTLE RETRACTION, THE BALLOON AND GUIDEWIRE WERE WITHDRAWN TOGETHER. A NEW GUIDEWIRE WAS THEN USED TO RE-ENTER THE CORONARY ARTERY AND COMPLETE THE SURGERY. BLEEDING WAS NOTED AT THE ACCESS SITE THEREFORE MANUAL COMPRESSION WAS USED TO STOP THE BLEEDING. PER THE PHYSICIAN, THE VERSATURN GUIDE WIRE DID NOT CAUSE OR CONTRIBUTE TO THE BLEEDING. ALTHOUGH THERE WAS A REPORT DELAY IN THE PROCEDURE, THERE WERE NO ADVERSE PATIENT EFFECTS THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21743211 ↗
• MalfunctionApr 1, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED AND A BALLOON CATHETER WAS ADVANCED OVER THE GUIDE WIRE HOWEVER BECAME STUCK ON THE DISTAL END OF THE GUIDE WIRE AND COULD NOT BE RETRACTED. AFTER MULTIPLE ANGLE ROTATIONS AND GENTLE RETRACTION, THE BALLOON AND GUIDEWIRE WERE WITHDRAWN TOGETHER. A NEW GUIDEWIRE WAS THEN USED TO RE-ENTER THE CORONARY ARTERY AND COMPLETE THE SURGERY. BLEEDING WAS NOTED AT THE ACCESS SITE THEREFORE MANUAL COMPRESSION WAS USED TO STOP THE BLEEDING. PER THE PHYSICIAN, THE VERSATURN GUIDE WIRE DID NOT CAUSE OR CONTRIBUTE TO THE BLEEDING. ALTHOUGH THERE WAS A REPORT DELAY IN THE PROCEDURE, THERE WERE NO ADVERSE PATIENT EFFECTS THEREFORE THE DELAY IS NOT CONSIDERED CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741279 ↗