HI-TORQUE COMMAND 1013731Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 08717648212130), received between Oct 19, 2017 and Aug 18, 2026 — classified as 32 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Material Separation” (51 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Material Separation; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303581 ↗
• InjuryMar 11, 2026Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE COMMAND 18 ST GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION. HOWEVER, RESISTANCE WAS NOTED WHEN THE GW WAS SUB-INTIMAL TO THE TARGET LESION. THEN DURING REMOVAL OF THE GW, THE DISTAL TIP BECAME SEPARATED DUE TO MEDIAL CALCIUM. A DECISION WAS MADE TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO EMBED THE TIP INTO THE INTIMA LAYER. ANOTHER UNSPECIFIED GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24570787 ↗
• MalfunctionDec 16, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POSTERIOR TIBIAL ARTERY WITH SEVERE CALCIFICATION. THE COMMAND 18 ST GUIDE WIRE WAS RESHAPED AND IT WAS NOTED THAT THE POLYMER WAS PEELING AT THE TIP. A NEW COMMAND 18 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 23824860 ↗
• MalfunctionDec 5, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERIOR VENA CAVA. THE COMMAND GUIDE WIRE WAS ADVANCED WITH A MICROCATHETER HOWEVER RESISTANCE WAS MET BETWEEN THE DEVICES. THE DEVICES WERE REMOVED TOGETHER WHEN IT WAS NOTED THE POLYMER HAD SEPARATED BUT REMAINED ON THE GUIDE WIRE. 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 23727832 ↗
• MalfunctionOct 7, 2025Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS 100% STENOSED. THE HT COMMAND 18 GUIDE WIRE WAS USED IN THE ANATOMY AND REMOVED. ONCE REMOVED THE TIP HAD AN ACUTE BEND AND SEPARATED OUTSIDE OF THE ANATOMY ABOUT TO RE-INSERT IN THE ANATOMY. A NON-ABBOTT .035 GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23236264 ↗
• MalfunctionOct 3, 2025Break; Peeled/Delaminated; Difficult to Advance; Material Split, Cut or Torn; Break; Peeled/Delaminated; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY, POPLITEAL, AND POSTERIOR TIBIAL ARTERY. FOLLOWING PRE-DILATION OF THE VESSEL WITH AN UNKNOWN BALLOON, THREE 10CM HT COMMAND 18 GUIDEWIRES (GW) WERE ATTEMPTED TO BE ADVANCED AND WERE NOTED TO HAVE DIFFICULTY WHEN BEING INSERTED INTO THE 5 FRENCH MICRO SHEATH, AND THE COATING BECAME BUNCHED AT THE TIP. THEREFORE, A NEW COMMAND WIRE WAS USED AND ADVANCED THROUGH THE SAME SHEATH SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ONE DEVICE WAS RECEIVED AND RETURN ANALYSIS REVEALED THAT THE POLYMER COATING WAS SEPARATED, TORN AND FOLDED OVER ITSELF. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED COATING BECOMING BUNCHED AT THE TIP MEANT THAT THE POLYMER COATING WAS SEPARATED AND FOLDED OVER ITSELF WITH TEAR BEING NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23213883 ↗
• MalfunctionSep 18, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE HT COMMAND 18 ST GUIDE WIRE (GW) WAS ADVANCED INTO THE PATIENT; HOWEVER, BECAME STUCK WITH A NON-ABBOTT 018 CATHETER, THE GW COULD NOT ADVANCE OR BE REMOVED FROM THE CATHETER; THEREFORE, BOTH DEVICES HAD TO BE REMOVED AS ONE UNIT. A HT COMMAND ES 300CM GW WAS ADVANCED INTO A NEW NON-ABBOTT CATHETER, BUT THE SAME ISSUE OCCURRED. BOTH DEVICES ALSO HAD TO BE REMOVED AS ONE UNIT. THE PROCEDURE WAS CONTINUED WITH A NEW COMMAND 18 GW AND A NEW NON-ABBOTT CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088586 ↗
• MalfunctionAug 18, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA). THE COMMAND 18 GUIDE WIRE WAS PLACED AND THE NON-ABBOTT ATHERECTOMY SYSTEM WAS USED OVER THE GUIDE WIRE CAUSING THE POLYMER COATING OF THE GUIDE WIRE TO PEEL OFF. BALLOONING WAS PERFORMED AFTER THE ATHERECTOMY AND THE COMMAND 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 22833420 ↗
• MalfunctionAug 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL ARTERY. A HT COMMAND 18 GUIDE WIRE CROSSED THE LESION WITH NO ISSUE AND THE NON-ABBOTT MICROCATHETER WAS ADVANCED OVER WITHOUT ISSUE. THE PHYSICIAN WANTED TO EXCHANGE THE GUIDE WIRE THEREFORE, THE COMMAND 18 GUIDE WIRE WAS REMOVED AND THE VIPERWIRE WAS ADVANCED. WHEN ATTEMPTING TO REMOVE THE MICROCATHETER IT WAS NOTED TO BE STUCK WITH THE VIPERWIRE AND THEREFORE, REMOVED AS ONE UNIT. ONCE OUTSIDE THE ANATOMY THE TIP OF THE MICROCATHETER APPEARED TO HAVE BLACK POLYMER COATING AND AS WELL AS SOME ON THE VIPERWIRE. HOWEVER, THE VIPERWIRE NEVER CAME IN CONTACT WITH THE COMMAND GUIDE WIRE. THE COMMAND GUIDE WIRE WAS NOT EXAMINED TO VERIFY IF THE COATING WAS PEELED, BUT IT IS BELIEVED SOME OF THE COATING PEELED OFF AND REMAINED ON THE MICROCATHETER. THE PROCEDURE WAS CONTINUED SUCCESSFULLY WITH A NEW COMMAND GUIDE CROSSING THE LESION, EXCHANGED FOR A NEW VIPER WIRE THAT WAS USED SUCCESSFULLY WITHOUT ISSUE WITH A DIAMONDBACK DEVICE. 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 22809784 ↗
• InjuryJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED PERONEAL ARTERY. A 10CM HI-TORQUE COMMAND 18 GUIDE WIRE ACCESSED THE PERONEAL ARTERY VIA THE LEFT COMMON FEMORAL ARTERY. DURING ADVANCEMENT, THE GUIDE WIRE TIP SEPARATED AND AN UNSPECIFIED BALLOON WAS USED TO EMBED THE TIP INTO A MILDLY DISEASED VESSEL WALL TISSUE. THIS CONCLUDED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22511531 ↗
• MalfunctionJul 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT TIBIAL ARTERY WITH CALCIFICATION. FOR POST DILATATION, AN ARMADA 18 BALLOON WAS USED SUCCESSFULLY WITH THE HT COMMAND 18 ST GUIDE WIRE (GW); HOWEVER, DURING REMOVAL OF THE BDC AND GW AT COMPLETION OF THE PROCEDURE, THE TIP OF THE GW BECAME SEPARATED IN THE GUIDE CATHETER. THE SEPARATED TIP REMAINED IN THE GUIDE CATHETER AND WAS ABLE TO BE REMOVED WITH THE GUIDE CATHETER. 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 22470213 ↗
• MalfunctionJun 9, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT TIBIAL ARTERY WITH NO TORTUOSITY AND HIGH CALCIFICATION. THE COMMAND GUIDE WIRE WAS USED WITH A NON-ABBOTT 018 CATHETER AND THERE WAS NO RESISTANCE DURING ADVANCEMENT OR REMOVAL; HOWEVER, WHEN IT WAS REMOVED FROM THE CATHETER, THE TIP OF THE WIRE SHREDDED/CAME APART BUT IT IS BELIEVED THE CORE IS IN ONE PIECE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE SAME CATHETER WAS USED WITH TWO NON-ABBOTT WIRES AND THE SAME ISSUE OCCURRED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169595 ↗
• MalfunctionMay 9, 2025Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. A HT COMMAND 18 GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH A 6F SLENDER SHEATH TO THE SFA BY ACCESSING THE LEFT DORSALIS PEDIS, FOLLOWED BY AN 18 NON-ABBOTT SUPPORT CATHETER. RESISTANCE WAS MET WITH THE CATHETER DURING REMOVAL OF THE HT COMMAND 18 GUIDEWIRE AND MORE FORCE THAN USUAL WAS USED TO REMOVE THE WIRE. ONCE OUTSIDE THE ANATOMY, THE COATING AT DISTAL TIP OF THE HT COMMAND 18 GUIDEWIRE WAS NOTED TO BE PEELED BACK. A SECOND HT COMMAND 18 GUIDEWIRE WAS ADVANCED OVER THE SAME NON-ABBOTT SUPPORT CATHETER, AND DURING REMOVAL, RESISTANCE WAS MET WITH THE CATHETER AND THE COATING AT DISTAL TIP OF THE HT COMMAND 18 GUIDEWIRE WAS ALSO NOTED TO BE PEELED BACK AFTER REMOVAL FROM THE PATIENT. ANGIO SHOWED NO SIGNS OF WIRE DISLODGEMENT. A NON-ABBOTT WIRE WAS THEN INSERTED AND THE NON-ABBOTT SUPPORT CATHETER WAS REMOVED. AN ORBITAL ATHERECTOMY SYSTEM, NON-ABBOTT BALLOON DILATATION CATHETER, AND SUPERA WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997340 ↗
• MalfunctionMay 9, 2025Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) THAT IS 100% STENOSED. A HT COMMAND 18 GUIDEWIRE WAS SUCCESSFULLY ADVANCED THROUGH A 6F SLENDER SHEATH TO THE SFA BY ACCESSING THE LEFT DORSALIS PEDIS, FOLLOWED BY AN 18 NON-ABBOTT SUPPORT CATHETER. RESISTANCE WAS MET WITH THE CATHETER DURING REMOVAL OF THE HT COMMAND 18 GUIDEWIRE AND MORE FORCE THAN USUAL WAS USED TO REMOVE THE WIRE. ONCE OUTSIDE THE ANATOMY, THE COATING AT DISTAL TIP OF THE HT COMMAND 18 GUIDEWIRE WAS NOTED TO BE PEELED BACK. A SECOND HT COMMAND 18 GUIDEWIRE WAS ADVANCED OVER THE SAME NON-ABBOTT SUPPORT CATHETER, AND DURING REMOVAL, RESISTANCE WAS MET WITH THE CATHETER AND THE COATING AT DISTAL TIP OF THE HT COMMAND 18 GUIDEWIRE WAS ALSO NOTED TO BE PEELED BACK AFTER REMOVAL FROM THE PATIENT. ANGIO SHOWED NO SIGNS OF WIRE DISLODGEMENT. A NON-ABBOTT WIRE WAS THEN INSERTED AND THE NON-ABBOTT SUPPORT CATHETER WAS REMOVED. AN ORBITAL ATHERECTOMY SYSTEM, NON-ABBOTT BALLOON DILATATION CATHETER, AND SUPERA WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21997331 ↗
• InjuryApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. DURING THE USE OF A 10CM HT COMMAND 18 GUIDEWIRE (GW) THE COIL WAS NOTED TO SHEAR OFF [SEPARATE] INSIDE THE ANATOMY. IT WAS ALSO NOTED THAT A 5F AND 6FR SHEATH WERE USED DURING THE PROCEDURE. THE SEPARATED COIL WAS ULTIMATELY REMOVED; HOWEVER, THE METHOD OF REMOVAL WAS NOT SPECIFIED. THERE WERE NO ADVERSE PATENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866052 ↗
• MalfunctionMar 28, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN ANTERIOR TIBIAL ARTERY VIA THE RIGHT FEMORAL ARTERY. THE HT COMMAND 18 GUIDE WIRE WAS ADVANCED OVER A NON-ABBOTT MICRO-CATHETER AND INSERTED INTO THE PATIENT ANATOMY TO WIRE THE LESION. THE GUIDE WIRE WAS PULLED OUT AND THE CATHETER ASPIRATED; HOWEVER, SPECKS OF BLACK COATING THAT CAME OFF THE TIP OF THE GUIDE WIRE, WERE NOTED IN THE SYRINGE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724326 ↗
• MalfunctionDec 27, 2024Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LEFT SUPERIOR FEMORAL ARTERY THAT IS 80% STENOSED. THE HT COMMAND GUIDE WIRE WAS ADVANCED AND RESISTANCE WAS FELT WITH ANATOMY. HOWEVER, ONCE REMOVED FROM THE ANATOMY THE COATING TIP WAS OBSERVED TO BE MISSING [PEELED OFF]. 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 21030806 ↗
• MalfunctionNov 6, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY (PTA). THE HT COMMAND GUIDEWIRE (GW) WAS ADVANCED INTO THE ANATOMY HOWEVER THE COATING ON THE GW WAS NOTED TO BE BUNCHED AND TORN. THE GW WAS REPLACED WITH A NON-ABBOTT GW AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620157 ↗
• MalfunctionOct 31, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  MEDSUN REPORT#: (B)(4). WIRE IS HYDROPHILIC AND CATHETER IS A SUPPORT CATHETER. WIRE WAS ABLE TO GO THROUGH THE BLOCKAGE BUT WAS STUCK IN THE CATHETER. BOTH WIRE AND CATHETER WERE REMOVED RESULTING IN LOSING PLACEMENT. NO HARM WAS DONE BUT PROCEDURE WAS ABORTED, RESULTING IN DELAY OF CARE AND LONGER STAY IN THE HOSPITAL. PER MD'S NOTES: POPLITEAL ANGIOGRAM DEMONSTRATED OCCLUSION OF THE SFA [SUPERFICIAL FEMORAL ARTERY] AND P1 SEGMENT. THEN USING 018 WIRE AND CATHETER, THE SFA OCCLUSION WAS CROSSED IN SUBINTIMAL FASHION AND SNARED IN THE TRUE LUMEN AT THE CFA [COMMON FEMORAL ARTERY]. THEN THE RETROGRADE 018 WIRE AND CATHETER WERE STUCK AND COULD NOT BE SNARED IN A FLOSSING FASHION. UNFORTUNATELY, WE THEN HAD TO REMOVE THE RETROGRADE CATHETER AND WIRE AS A UNIT AND LOST THE PEDAL ACCESS AND COULD NOT SUCCESSFULLY RECANALIZE THE SFA OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577498 ↗
• MalfunctionOct 8, 2024

  WIRE IS HYDROPHILIC AND CATHETER IS A SUPPORT CATHETER. WIRE WAS ABLE TO GO THROUGH THE BLOCKAGE BUT WAS STUCK IN THE CATHETER. BOTH WIRE AND CATHETER WERE REMOVED RESULTING IN LOSING PLACEMENT. NO HARM WAS DONE BUT PROCEDURE WAS ABORTED, RESULTING IN DELAY OF CARE AND LONGER STAY IN THE HOSPITAL. PER MD'S NOTES: POPLITEAL ANGIOGRAM DEMONSTRATED OCCLUSION OF THE SFA [SUPERFICIAL FEMORAL ARTERY] AND P1 SEGMENT. THEN USING 018 WIRE AND CATHETER, THE SFA OCCLUSION WAS CROSSED IN SUBINTIMAL FASHION AND SNARED IN THE TRUE LUMEN AT THE CFA [COMMON FEMORAL ARTERY]. THEN THE RETROGRADE 018 WIRE AND CATHETER WERE STUCK AND COULD NOT BE SNARED IN A FLOSSING FASHION. UNFORTUNATELY, WE THEN HAD TO REMOVE THE RETROGRADE CATHETER AND WIRE AS A UNIT AND LOST THE PEDAL ACCESS AND COULD NOT SUCCESSFULLY RECANALIZE THE SFA OCCLUSION. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, HI-TORQUE COMMAND (PER SITE REPORTER). DEVICE GIVEN TO FIELD REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395870 ↗
• MalfunctionOct 8, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE LOWER EXTREMITY. DURING ADVANCEMENT OF A HT COMMAND GUIDEWIRE (GW) THE POLYMER TIP WAS NOTED TO SHRED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER HT COMMAND GW TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT THE DEVICE WAS RETURNED AND PART OF THE POLYMER COATING WAS NOT RETURNED; HOWEVER, THE SITE CONFIRMED THAT NO PARTS REMAIN IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395299 ↗
• MalfunctionSep 30, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. THE HT COMMAND 18 GUIDE WIRE WAS ADVANCED THROUGH THE SHEATH INTRODUCER AND A CROSSING CATHETER WAS ADVANCED. WHEN RE-LOADING THE COMMAND GUIDE WIRE, THE BLACK COATING WAS NOTICED TO BE PEELING OFF THEREFORE THE GUIDE WIRE WAS NOT REUSED. ANOTHER COMMAND WIRE WAS USED TO CONTINUE THE PROCEDURE WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20336293 ↗
• MalfunctionSep 19, 2024Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH NO CALCIFICATION OR TORTUOSITY. THE COMMAND 18 GUIDE WIRE WAS BEING TORQUED BUT THEN IT WAS NOTED THE TORQUING STOPPED. THE WIRE WAS REMOVED AND IT WAS FOUND THAT THE POLYMER COATING ON THE TIP HAD BEGUN TO PEEL. ALL OF THE COATING WAS STILL ON THE WIRE AND NOTHING REMAINED IN THE PATIENT, BUT IT HAD BEGUN TO COME OFF. ANOTHER COMMAND 18 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 20258053 ↗
• MalfunctionSep 5, 2024Break; Stretched; Failure to Advance; Break; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION OF THE ANTERIOR TIBIAL ARTERY. THE HI-TORQUE (HT) COMMAND 18 GUIDE WIRE FAILED TO CROSS DUE TO THE ANATOMY. THE GUIDE WIRE WAS NOTED TO BE BROKEN BUT REMAINED IN ONE PIECE. THE POLYMER WAS NOTED TO BE STRETCHED. THE DEVICE WAS REMOVED INDEPENDENTLY AND HAD NO RESISTANCE DURING REMOVAL. ANOTHER DEVICE WAS USED TO COMPLETE 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 20150508 ↗
• MalfunctionAug 29, 2024Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT SUPERIOR FEMORAL ARTERY. THE HT COMMAND GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED WITH A NON-ABBOTT MICROCATHETER; HOWEVER, BECAME STUCK DURING ADVANCEMENT. DURING REMOVAL WITH ADDITIONAL FORCE, THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED INDEPENDENTLY BUT WAS UNSUCCESSFUL. THEREFORE, THE GUIDE WIRE AND MIRCO-CATHETER WERE REMOVED TOGETHER. AFTER REMOVAL POLYMER CODING OF THE COMMAND GUIDE WIRE WAS NOTED TO BE PEELED OFF. NO COATING WAS LEFT IN THE ANATOMY AND PATIENT WAS TREATED WITH ANOTHER DEVICE. 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 20097283 ↗