HI-TORQUE TURNTRAC 1020014Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648222726), received between Jul 18, 2018 and Jan 2, 2026 — classified as 13 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. A SCOREFLEX BALLOON WAS USED. WHEN REMOVING THE SCOREFLEX BALLOON, THE WIRE WAS ALSO REMOVED UNINTENTIONALLY, RESULTING IN THE WIRE RUPTURING [SEPARATION]. BOTH THE BODY AND TIP OF THE WIRE WERE RETRIEVED WITH A SNARE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946427 ↗
• MalfunctionDec 1, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (DLAD) ARTERY. THE HI-TORQUE (HT) TURNTRAC GUIDEWIRE WAS ADVANCED TO THE TARGET LESION. A DEVICE WAS ATTEMPTED TO ADVANCE ALONG THE GUIDEWIRE BUT COULD NOT CROSS. THE GUIDEWIRE WAS FOUND TO BE FRAYED [BREAK] UPON INSPECTION. A NON-ABBOTT GUIDEWIRE COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 23686716 ↗
• InjuryOct 15, 2025Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE TURNTRAC GUIDE WIRE WAS USED AS A WORKHORSE; HOWEVER IT COULD NOT CROSS THE PROXIMAL TORTUOSITY SO THE PHYSICIAN DECIDED TO EXCHANGE FOR A NON-ABBOTT WIRE. AFTER REMOVAL OF THE TURNTRAC GUIDE WIRE, IT WAS NOTED THAT THE RADIOPAQUE TIP OF THE WIRE REMAINED IN THE VESSEL. NO RESISTANCE WAS NOTED DURING REMOVAL OF THE WIRE. THE SEPARATED PORTION WAS ULTIMATELY REMOVED AFTER 3 HOURS OF USING A SNARE AND GUIDING CATHETER MANIPULATION. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280827 ↗
• InjurySep 30, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A HT TURNTRAC GUIDE WIRE (GW) WAS NOTED TO BE JAILED BY A PREVIOUSLY IMPLANTED STENT IN THE LAD, AND DURING ITS REMOVAL THE GW SNAPPED AT THE DISTAL TIP. THE SEPARATED TIP WAS EMBEDDED TO THE VESSEL WALL BEHIND THE STENT, AND ANOTHER GW WAS USED TO DETERMINE HOW MUCH OF THE SEPARATED PIECE WAS LEFT IN THE LEFT MAIN ARTERY. A CLINICAL DELAY WAS REPORTED. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE DEVICE WAS RECEIVED AND THE PRODUCT RETURN ANALYSIS COULD NOT CONFIRM THE SEPARATED TIP. IT WAS CONFIRMED BY THE ACCOUNT THE REPLACEMENT DEVICE WAS INADVERTENTLY RETURNED WHICH WAS NOTED TO HAVE NO ISSUES DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20335625 ↗
• MalfunctionSep 27, 2024Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY. THE .014 HT TURNTRAC GUIDE WIRE BECAME TANGLED WITH NON-ABBOTT CATHETER WHEN ATTEMPTING TO REMOVE THE CATHETER. THE GUIDE WIRE AND CATHETER WERE REMOVED TOGETHER AS ONE UNIT. ONCE REMOVED THE TIP OF THE GUIDE WIRE WAS OBSERVED TO BE ROLLED UP. NO OTHER DEVICE WAS USED AS THIS WAS THE END OF THE PROCEDURE. 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 20322728 ↗
• MalfunctionJul 25, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. RESISTANCE WAS MET REMOVING THE HT TURNTRAC GUIDE WIRE. WHEN REMOVED FROM THE ANATOMY THE COILS WERE NOTED TO BE UNRAVELED. 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 19825481 ↗
• InjuryDec 13, 2023Entrapment of Device; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Entrapment of Device; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 70% STENOSIS. THE TURNTRAC GUIDE WIRE WAS USED AS A SIDEARM PROTECTION WIRE DURING THE PROCEDURE AND A STENT WAS IMPLANTED. THE WIRE WAS TRAPPED BY THE STENT. DURING WITHDRAWAL OF THE TURNTRAC GUIDE WIRE, THERE WAS RESISTANCE WITH THE STENT AND FORCE WAS USED, CAUSING THE TIP OF THE WIRE TO FALL OFF. THE TIP WAS EMBEDDED WITH A STENT TO THE VESSEL. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18318900 ↗
• InjuryDec 12, 2023Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN BOTH THE ANTERIOR DESCENDING BRANCH AND THE DIAGONAL BRANCH. THE HI-TORQUE (HT) TURNTRAC GUIDE WIRE REACHED THE DISTAL END OF THE DIAGONAL BRANCH WITHOUT RESISTANCE WHILE A NON-ABBOTT GUIDE WIRE REACHED THE ANTERIOR DESCENDING BRANCH. HOWEVER, AFTER THE LESIONS WERE TREATED, IT APPEARED THAT THE GUIDE WIRE WAS UNDER THE STENT AND THE PHYSICIAN USED A SMALL BALLOON TO TRY TO RETRIEVE THE GUIDE WIRE OF THE PULLING WIRE BUT BROKE. FORCE WAS APPLIED DURING ATTEMPT AT REMOVAL. UNDER INTRAVASCULAR ULTRASOUND, IT WAS FOUND THAT THE GUIDE WIRE HAD THE POSSIBILITY OF BEING IN THE STENT, AND FINALLY DECIDED TO PLACE AN ADDITIONAL STENT TO COMPRESS THE GUIDE WIRE AND FINALLY COMPLETED THE OPERATION. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18314660 ↗
• InjuryJun 23, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. DURING ADVANCEMENT OF THE 014 HT TURNTRAC 190 PHC WW GUIDEWIRE (GW), THE GW BECAME STUCK WITH THE INTIMA WALL. THE GW DID NOT REACH THE TARGET LESION AND THE GW WAS REMOVED FROM THE ANATOMY. AFTER REMOVAL, A PIECE OF TISSUE WAS NOTED TO BE ON THE TIP OF GW. THERE WAS NO ADVERSE PATIENT SEQUELA. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17191140 ↗
• InjuryFeb 24, 2023Break; Stretched; Failure to Advance; Break; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID CIRCUMFLEX CORONARY ARTERY WITH 70% STENOSIS AND NO CALCIFICATION OR TORTUOSITY. THE 014 HT TURNTRAC WAS BEING ADVANCED THROUGH THE OCCLUSION, BUT WAS NOT MOVING FORWARD. IT WAS OBSERVED THAT THE WIRE WAS DAMAGED AND WAS UNCOILED [UNRAVELED]. THE TIP WAS SEPARATED BUT REMAINED CONNECTED. THE GUIDEWIRE WAS REMOVED WITH THE HELP OF A MICRO CATHETER AND A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16438013 ↗
• InjurySep 2, 2022Entrapment of Device; Difficult to Remove; Material Separation; Stretched; Entrapment of Device; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN 014 HT TURNTRAC GUIDE WIRE (GW) BECAME JAILED AND UNRAVELED CAUSING THE TIP TO SEPARATE IN THE ANATOMY. FEMORAL ACCESS WAS OBTAINED, AND MULTIPLE WIRES WERE THEN ADVANCED AND WRAPPED OVER THE SEPARATED GUIDE WIRE TIP TO REMOVE IT FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. A NON-ABBOTT DEVICE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353264 ↗
• InjurySep 2, 2022Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE CIRCUMFLEX (CX) ARTERY. AN 014 HT TURNTRAC GUIDE WIRE (GW) BECAME JAILED AND UNRAVELED CAUSING THE TIP TO SEPARATE IN THE ANATOMY. MULTIPLE WIRES WERE THEN ADVANCED AND WRAPPED OVER THE SEPARATED GUIDE WIRE TIP TO REMOVE IT FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. A NON-ABBOTT DEVICE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353122 ↗
• MalfunctionSep 2, 2022Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. THE .014 HT TURNTRAC GUIDEWIRE (GW) WAS ADVANCED AND POSITIONED. AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS ADVANCED ON THE GW; HOWEVER, WHEN ATTEMPTING TO REMOVE THE IVUS CATHETER FROM THE GW, THE CATHETER BECAME STUCK ON THE GW. THE GW AND CATHETER HAD TO BE REMOVED TOGETHER AS A SINGLE UNIT. IT WAS NOTED THAT THE GW BECAME UNRAVELED AND UNCOILED IN THE GUIDE CATHETER. IT WAS ALSO OBSERVED THAT THE COILS DETACHED FROM THE CORE AND DID NOT REMAIN INTACT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PROCEDURE CONTINUED WITH A NON-ABBOTT GW. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352605 ↗
• InjuryOct 15, 2021Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY (LAD) ARTERY BACK INTO THE LEFT MAIN (LM). THE TURNTRAC WIRE WAS JAILED BEHIND STENT DURING BIFURCATION STENTING LAD BACK INTO LM. BOTH PHYSICIANS MENTIONED THAT THE WIRE WAS NOT ANY MORE SEVERELY JAILED THAN USUAL AND THERE WAS NO RESISTANCE ON THE WIRE. WHEN REMOVING THE GUIDE WIRE, IT SNAPPED A FEW CENTIMETERS PROXIMAL TO THE RADIOPAQUE SECTION. THE WIRE THEN UNRAVELED, RELEASED FRAGMENTS THROUGHOUT THE PATIENTS LAD AND LM. THERE WAS A 2-3 HOUR PERIOD OF SNARING FRAGMENTS OF THE WIRE OUT OF THE LAD AND LM USING THE INTRAVASCULAR ULTRASOUND CATHETER AND A NON-ABBOTT GUIDE WIRE. ALL FRAGMENTS THAT WERE VISIBLE ON ANGIOGRAM WERE REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642320 ↗
• MalfunctionJul 17, 2020Break; Difficult to Remove; Material Separation; Difficult to Advance; Material Deformation; Break; Difficult to Remove; Material Separation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO RIGHT CORONARY ARTERY (RCA). A 014 HT TURNTRAC GUIDE WIRE WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON. BALLOON WAS REMOVED AND A NON-ABBOTT STENT WAS ATTEMPTED TO ADVANCE, BUT RESISTANCE WAS REPORTED WITH THE GUIDE WIRE. THE ENTIRE SYSTEM WAS REMOVED INCLUDING THE GUIDE WIRE DUE TO RESISTANCE WITH THE STENT DELIVERY SYSTEM. IT WAS NOTED THAT THE COILS OF THE GUIDE WIRE HAD DETACHED, BUT STILL REMAINED ON THE GUIDE WIRE. AND WRINKLING OF THE COILS WOULD NOT ALLOW THE ADVANCEMENT OF THE NON-ABBOTT STENT. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290792 ↗
• MalfunctionApr 13, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE TURNTRAC GUIDE WIRE WAS INSERTED TO REACH THE LEFT CIRCUMFLEX CORONARY ARTERY, BUT WAS UNABLE TO CROSS. A BALLOON DILATATION CATHETER (BDC) WAS USED LIKE AN EXTRA SUPPORT MICRO CATHETER AND LOADED ON TO THE TURNTRAC. THE BDC AND TURNTRAC WERE ADVANCED BUT WERE UNABLE TO CROSS THE HEAVILY CALCIFIED LEFT CIRCUMFLEX POSSIBLY DUE TO THE CALCIUM. THE INTENT WAS TO REMOVE THE BDC AND KEEP THE TURNTRAC IN THE ANATOMY. DURING REMOVAL OF THE BDC FROM THE TURNTRAC, THE GUIDE WIRE WAS NOTED TO HAVE SEPARATED IN TWO PIECES. THE ENTIRE WIRE WAS REMOVED FROM THE ANATOMY. THE PROCEDURE CONTINUED WITH A WHISPER LS GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9953432 ↗
• MalfunctionFeb 6, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORUTOUS AND DISSECTED LESION IN THE MID RIGHT CORONARY ARTERY. A 014 HT TURNTRAC GUIDE WIRE WAS ADVANCED; HOWEVER, THERE WAS A BREAK IN THE COILS AROUND 20CM FROM THE TIP. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED, BUT IT WAS CATCHING THE COIL AT THE BREAK POINT AND PUSHED THE COILS TOWARDS THE TIP OF THE WIRE. THE COILS ONLY SLID FORWARDS BY A FEW CENTIMETERS. THE BALLOON COULDN¿T GET PAST THE BREAK POINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY EXCHANGING THE WIRE WITH AN UNSPECIFIED GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678293 ↗
• MalfunctionNov 25, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN RIGHT CORONARY ARTERY. THE TURNTRAC GUIDE WIRE KINKED WHEN EXITING THE GUIDE CATHETER AND WHEN REMOVING THE TURNTRAC GUIDE WIRE, THE GUIDE WIRE GOT CAUGHT IN THE INTRODUCER SHEATH. FORCE WAS USED DURING REMOVAL AND THE GUIDE WIRE WAS WITHDRAWN. ONCE OUTSIDE OF THE ANATOMY, THE TIP OF THE GUIDE WIRE WAS NOTED TO HAVE SEPARATED IN TWO PIECES, AT THE RADIOPAQUE MARKER. A NEW TURNTRAC GUIDE WIRE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372422 ↗
• InjuryNov 13, 2019Entrapment of Device; Material Separation; Stretched; Entrapment of Device; Material Separation; Stretched

  ADDITIONAL INFORMATION: SOME OF THE SEPARATED GUIDE WIRE WAS NOT ABLE TO BE REMOVED AS IT WAS JAILED BEHIND THE STENT. AN OCT CONFIRMED NO LOOSE WIRE PIECE REMAINED IN THE LUMEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9319230 ↗
• MalfunctionAug 7, 2019Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 014 TURNTRAC GUIDE WIRE WAS JAILED BEHIND AN UNSPECIFIED STENT. RESISTANCE WAS FELT WITH THE STENT DURING WITHDRAWAL. AFTER REMOVAL IT WAS NOTED THAT THE COILS WERE STRETCHED AND POSSIBLY FRACTURED. THE PROCEDURE WAS COMPLETE AT THAT POINT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8871718 ↗
• MalfunctionMar 12, 2019Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT PRIOR TO USE, WHEN SHAPING THE TIP OF A HI-TORQUE TURNTRAC GUIDE WIRE, THE TIP UNRAVELED. IT COULD NOT BE CONFIRMED THAT THE CORE/COILS WERE INTACT. THE GUIDE WIRE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT GUIDE WIRE WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8414704 ↗
• MalfunctionJan 11, 2019Material Separation; Stretched; Failure to Advance; Material Separation; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL, NARROW, RIGHT CORONARY ARTERY. AFTER A FAILED ATTEMPT TO CROSS DUE TO THE ANATOMY, THE HI-TORQUE TURNTRAC GUIDE WIRE WAS REMOVED. OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE COILS WERE STRETCHED. THE CORE DID NOT SEPARATE. THE PROCEDURE WAS CONTINUED WITH A WHISPER GUIDE WIRE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED THE CORE AND TIP COILS WER SEPARATED. FOLLOW-UP CONFIRMED THE CORE SEPARATED OUTSIDE THE PATIENT AFTER PULLING BACK THE TURNTRAC OUT OF THE GUIDING CATHETER. THE PHYSICIAN OBSERVED THE DAMAGED COILS AND THEN IT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241097 ↗
• MalfunctionOct 9, 2018Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT WHILE PRACTICING TIP SHAPING OF A HI-TORQUE TURNTRAC GUIDE WIRE, THE TIP WAS NOTED TO UNRAVEL. THE GUIDE WIRE WAS DISCARDED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7949730 ↗
• MalfunctionSep 11, 2018Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Material Too Soft/Flexible; Difficult to Remove; Stretched; Deformation Due to Compressive Stress; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE TURNTRAC GUIDE WIRE WAS SUCCESSFULLY ADVANCED TO THE OBTUSE MARGINAL/LEFT CIRCUMFLEX CORONARY ARTERY WITHOUT RESISTANCE. A 2.0 TREK WAS ADVANCED OVER THE TURNTRAC GUIDE WIRE AND THE TREK WAS INFLATED TO NOMINAL PRESSURE. AFTER THE TREK WAS DEFLATED, A GAP WAS NOTED ON THE TURNTRAC GUIDEWIRE VIA FLUOROSCOPY. APPROXIMATELY 20 MM FROM THE TIP OF THE GUIDEWIRE, A KINKED PROLAPSE WAS NOTED. THE DOCTOR DID NOT WANT TO CONTINUE USING THE TURNTRAC. A NON-ABBOTT GUIDE WIRE WAS INSERTED TO MAINTAIN VESSEL ACCESS. THE TURNTRAC WAS REMOVED, BUT RESISTANCE WAS MET DURING REMOVAL. THE ENTIRE TURNTRAC WAS REMOVED, BUT IT WAS UNRAVELED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864261 ↗
• InjuryAug 17, 2018Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH NO TORTUOSITY AND NO CALCIFICATION. A HI-TORQURE (HT) TURNTRAC GUIDE WIRE WAS ADVANCED AND RESISTANCE WAS FELT IN AN AREA WHERE AN UNSPECIFIED STENT WAS PREVIOUSLY IMPLANTED APPROXIMATELY ONE YEAR AGO AND COULD NOT REACH THE LCX. THE TIP OF THE HT TURNTRAC GUIDE WIRE BECAME STUCK IN THE AREA, DURING AN ATTEMPT TO PULL THE GUIDE WIRE BACK RESISTANCE WAS FELT WITH THE ANATOMY AND A DISTAL PORTION OF THE GUIDE WIRE SEPARATED INCLUDING THE TIP. THE SEPARATED PORTION WAS FREE FLOATING IN THE PATIENT ANATOMY AND A NON-ABBOTT (SPRINTER) BALLOON DILATATION CATHETER (BDC) WAS USED TO PUSH THE SEPARATED PORTION INTO A SMALL BRANCH OF THE OBTUSE MARGINAL (OM). AN UNSPECIFIED STENT WAS THEN IMPLANTED TO EMBED THE SEPARATED PORTION IN THE OM. AN ADDITIONAL UNSPECIFIED STENT WAS IMPLANTED TO TREAT THE TARGET LESION IN THE LCX. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7795539 ↗