HI-TORQUE COMMAND 2078175Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 08717648176685), received between Sep 6, 2016 and Sep 22, 2026 — classified as 47 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (70 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 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861663 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT A DIAGNOSTIC PROCEDURE WAS PERFORMED WITH A HT COMMAND ES GUIDE WIRE FOR A POSTERIOR TIBIAL ARTERY LESION. IT WAS NOTED THAT THE GUIDE WIRE TIP WAS SHEARED OFF [BROKEN] BUT WAS STILL INTACT. THE GUIDE WIRE WAS REMOVED WITHOUT ISSUE AND A NEW NON-ABBOTT GUIDE WIRE 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 24523008 ↗
• MalfunctionJan 12, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POPLITEAL ARTERY. A NON-ABBOTT BALLOON WAS ADVANCED OVER THE HT COMMAND ES GUIDE WIRE WHEN RESISTANCE WAS NOTED BETWEEN THE DEVICES. THE BALLOON AND GUIDE WIRE WERE STUCK TOGETHER; THEREFORE, THE DEVICES WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED BALLOON AND 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 24044598 ↗
• MalfunctionJan 9, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE POPLITEAL ARTERY. THE COMMAND ES GUIDE WIRE WAS USED IN THE PROCEDURE HOWEVER THE COATING WAS STRIPPED OFF, CAUSING THE GUIDE WIRE TO BECOME ENTRAPPED WITHIN THE BALLOON CATHETER. THE ENTIRE SYSTEM WAS REMOVED TOGETHER AND NO PORTION OF THE GUIDE WIRE WAS LEFT IN THE PATIENT. A NON-ABBOTT GUIDE WIRE 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 24028529 ↗
• MalfunctionJan 2, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH CALCIFICATION. THREE HT COMMAND ES 300CM GUIDE WIRES (GW) WERE USED IN THE PROCEDURE AND RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE GUIDE WIRES WITH THE ANATOMY. THE GUIDE WIRES WERE DIFFICULT TO TRACK AND BECAME KINKED. ADDITIONALLY, THE GW TIPS BROKE BUT REMAINED IN ONE PIECE. A 4TH HT COMMAND GW WAS ABLE TO CONTINUE THE PROCEDURE WITHOUT ISSUE. THERE WERE 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 23944528 ↗
• MalfunctionJan 2, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH CALCIFICATION. THREE HT COMMAND ES 300CM GUIDE WIRES (GW) WERE USED IN THE PROCEDURE AND RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE GUIDE WIRES WITH THE ANATOMY. THE GUIDE WIRES WERE DIFFICULT TO TRACK AND BECAME KINKED. ADDITIONALLY, THE GW TIPS BROKE BUT REMAINED IN ONE PIECE. A 4TH HT COMMAND GW WAS ABLE TO CONTINUE THE PROCEDURE WITHOUT ISSUE. THERE WERE 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 23944495 ↗
• MalfunctionJan 2, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE COMMON FEMORAL ARTERY (CFA) WITH CALCIFICATION. THREE HT COMMAND ES 300CM GUIDE WIRES (GW) WERE USED IN THE PROCEDURE AND RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE GUIDE WIRES WITH THE ANATOMY. THE GUIDE WIRES WERE DIFFICULT TO TRACK AND BECAME KINKED. ADDITIONALLY, THE GW TIPS BROKE BUT REMAINED IN ONE PIECE. A 4TH HT COMMAND GW WAS ABLE TO CONTINUE THE PROCEDURE WITHOUT ISSUE. THERE WERE 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 23944491 ↗
• MalfunctionDec 10, 2025Break; Stretched; Deformation Due to Compressive Stress; Break; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FEMOROPOPLITEAL SEGMENT OF THE LEFT LEG. THERE WAS NO HIGH-GRADE STENOSIS, ALTHOUGH THERE WAS GREATER TORTUOSITY IN THE LEFT FEMORAL ARTERY WHERE THE FEMORAL ACCESS WAS PERFORMED. THE TARGET ZONE WAS TREATED WITH THE STEALTH 360 ATHERECTOMY, FOLLOWED BY ANGIOPLASTY USING UNSPECIFIED ARMADA BALLOONS AND THE VIPERWIRE WAS USED. FINALLY, UPON WITHDRAWING THE VIPERWIRE TOGETHER WITH THE CATHETER, THE GUIDEWIRE FRACTURED INTO TWO PARTS. THE COIL DETACHED AND LODGED IN THE DISTAL PORTION OF THE POPLITEAL SEGMENT, WHILE THE OTHER TWO FRAGMENTS REMAINED INSIDE THE STEALTH 360 CATHETER. AS A RESULT, WHEN THE CATHETER WAS COMPLETELY REMOVED, NOTHING WAS LEFT BEHIND EXCEPT THE COIL TIP. AS A RESCUE MEASURE, A "LAZO" WAS USED TO CAPTURE AND EXTRACT THE TIP AND DISSECTIONS WERE NOTED AT THIS TIME. DUE TO THIS RESCUE MANEUVER, THE COMMAND ES GUIDE WIRE WAS INTRODUCED TO MAINTAIN ACCESS. THE TIP OF THE COMMAND ES GUIDE WIRE UNRAVELED DURING THE PROCEDURE AND THE COILS WERE NOTED TO BE BROKEN. THE AREA WAS STENTED WITH TWO UNSPECIFIED SUPERA SELF EXPANDING STENTS TO TREAT THE DISSECTIONS PRODUCED DURING THE RESCUE, THUS COMPLETING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771843 ↗
• MalfunctionNov 19, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE POPLITEAL ARTERY. DURING USE OF THE COMMAND ES GUIDE WIRE IN THE ANATOMY, THE COATING STRIPPED OFF, CAUSING THE GUIDE WIRE TO BECOME ENTRAPPED WITHIN THE BALLOON CATHETER. THE GUIDE WIRE AND BALLOON CATHETER WERE THEN REMOVED TOGETHER. A NEW GUIDE WIRE WAS USED TO CONTINUE 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 23594202 ↗
• MalfunctionNov 19, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE POPLITEAL ARTERY. DURING USE OF THE COMMAND ES GUIDE WIRE IN THE ANATOMY, THE COATING STRIPPED OFF, CAUSING THE GUIDE WIRE TO BECOME ENTRAPPED WITHIN THE BALLOON CATHETER. THE GUIDE WIRE AND BALLOON CATHETER WERE THEN REMOVED TOGETHER. A NEW GUIDE WIRE WAS USED TO CONTINUE 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 23594126 ↗
• MalfunctionNov 6, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE POPLITEAL ARTERY. DURING USE OF THE COMMAND ES GUIDE WIRE IN THE ANATOMY, THE COATING STRIPPED OFF, CAUSING THE GUIDE WIRE TO BECOME ENTRAPPED WITHIN THE BALLOON CATHETER. THE GUIDE WIRE AND BALLOON CATHETER WERE THEN REMOVED TOGETHER. A NEW GUIDE WIRE WAS USED TO CONTINUE 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 23485131 ↗
• InjuryOct 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT ACUTE AND SUBACUTE THROMBOSIS IN THE FEMOROPOPLITEAL REGION. A HT COMMAND GUIDEWIRE (GW) WAS USED IN COMBINATION WITH THE NON-ABBOTT THROMBECTOMY SYSTEM; HOWEVER THE GUIDEWIRE LOST PART OF ITS HYDROPHILIC COATING. THE PROCEDURE WAS CONTINUED WITH ANOTHER GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402152 ↗
• InjuryOct 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO PERFORM ATHERECTOMY IN THE POSTERIOR TIBIAL ARTERY. THE PHOENIX ATHERECTOMY SYSTEM AND THE COMMAND ES GUIDEWIRE WERE ADVANCED TO THE TARGET LESION HOWEVER DURING USE, THE GUIDE WIRE TIP SEPARATED. A DRUG ELUTING STENT WAS IMPLANTED TO TRAP THE SEPARATED TIP IN THE SUBINTIMAL SPACE OF THE POSTERIOR TIBIAL ARTERY. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23356942 ↗
• 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 23088787 ↗
• MalfunctionSep 17, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE TIBIAL AND POPLITEAL ARTERIES WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE HYDROPHILIC COATING OF THE COMMAND 14 GUIDE WIRE CORE AND TIP WAS THOUGHT TO HAVE STRIPPED OFF DUE TO THE RESISTANCE NOTED DURING ADVANCEMENT. THE WIRE BECAME ENTRAPPED WITHIN AN UNSPECIFIED BALLOON CATHETER. AS A RESULT, THE COMMAND GUIDE WIRE AND BALLOON WERE REMOVED TOGETHER. A NON-ABBOTT WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 23074302 ↗
• InjurySep 15, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR AND LEFT POSTERIOR TIBIAL ARTERIES VIA LEFT FEMORAL ACCESS. THE NON-ABBOTT GUIDING CATHETER WAS IN PLACE IN THE LEFT POSTERIOR TIBIAL AND THE COMMAND 14 GUIDE WIRE WAS CURLED AND PUSHED THROUGH THE OCCLUDED VESSEL; HOWEVER, NO RESISTANCE WAS REPORTED. AS THE WIRE WAS PULLED BACK THROUGH THE OCCLUSION, THE TIP BECAME STUCK IN THE OCCLUSION, SEPARATED AND REMAINED IN THE OCCLUSION. NO ATTEMPT WAS MADE TO RETRIEVE THE SEPARATED PIECE. THE PATIENT IS DOING WELL AND THERE IS NO CONCERN THAT THE FRAGMENT WILL MOVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23054318 ↗
• MalfunctionAug 11, 2025Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT A CLINICALLY SIGNIFICANT DELAY OCCURRED. THE COATING ON THE WIRE WAS BUNCHED UP RATHER THAN STRIPPED. THE PATIENT HAD WORSENING PAIN AND A DIGITAL DRY NECROSIS WOUND ON THE TOE WHICH WAS NOT HEALING PROPERLY. THERE WAS THROMBOSIS NOTED AND THE PATIENT REQUIRED AMPUTATION IN ANOTHER PROCEDURE TO TREAT THE THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions; Pain; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 22773487 ↗
• InjuryAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE POSTERIOR TIBIAL ARTERY. THE COMMAND 14 GUIDE WIRE WAS ADVANCED WITH A NON-ABBOTT BALLOON CATHETER TO THE TARGET LESION HOWEVER WHEN THE BALLOON WAS INFLATED, THE TIP OF THE GUIDE WIRE SEPARATED. THE SEPARATED PORTION WAS NOT RETRIEVED AND REMAINS IN THE PATIENT ANATOMY. PER THE PHYSICIAN NO FURTHER INTERVENTION IS CURRENTLY PLANNED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22700793 ↗
• MalfunctionJul 18, 2025Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY THAT IS 80% STENOSED. THE HT COMMAND ES 14 GUIDE WIRE WAS PLACED IN THE ANATOMY WITH RESISTANCE FELT AND AFTER SOME TIME IT WAS OBSERVED THAT THE GLOVES HAD STAINED GREEN WITH THE COATING OF THE WIRE. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE 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 22545140 ↗
• MalfunctionJul 14, 2025Break; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Break; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 300CM HT COMMAND GUIDEWIRE (GW) WAS USED WITH A NON-ABBOTT LASER ATHERECTOMY DEVICE; HOWEVER DURING THE PROCEDURE THE WIRE WAS NOTED TO BREAK IN ONE LOCATION AND COMPLETELY SEPARATE IN ANOTHER LOCATION. THE GW WAS REMOVED AND THE SEPARATION PORTION WERE RECEIVED. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501481 ↗
• MalfunctionJul 11, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SEVERELY CALCIFIED, NON TORTUOUS, 100% STENOSED RIGHT ANTERIOR TIBIAL ARTERY THROUGH THE LEFT COMMON FEMORAL ARTERY (CFA). A 3X240 MM BALLOON FROM ANOTHER MANUFACTURER WAS ADVANCED OVER THE COMMAND ES GUIDE WIRE THROUGH A 6FR 90 CM SHEATH BUT THE BALLOON STOPPED HALFWAY THROUGH THE SHEATH AS IT WAS STUCK ON THE COMMAND GUIDE WIRE. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. OUTSIDE THE ANATOMY THE DEVICES WERE ATTEMPTED TO BE REMOVED FROM EACH OTHER AS THE PHYSICIAN WANTED TO RE-USE THE COMMAND WIRE, BUT THE COMMAND WIRE SEPARATED AND A PIECE REMAINS INSIDE THE BALLOON. A NEW SAME SIZE BALLOON AND NEW COMMAND GUIDE WIRE WERE 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 22480058 ↗
• MalfunctionJun 27, 2025Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, LEFT SUPERFICIAL FEMORAL ARTERY. DURING ADVANCEMENT OF A 300CM HI-TORQUE (HT) COMMAND GUIDE WIRE, RESISTANCE WAS MET DUE TO ANATOMY AND UNABLE TO CROSS. UPON REMOVAL, THE BLACK COATING OF THE HT COMMAND GUIDEWIRE WAS NOTED TO BE PEELING FROM THE CORE. AN UNSPECIFIED DEVICE OF THE SAME SIZE 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 22349837 ↗
• MalfunctionJun 13, 2025Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL AND SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) COMMAND ES GUIDE WIRE WAS ADVANCED WITHOUT ISSUES. AN ATHERECTOMY DEVICE WAS ADVANCED TOGETHER WITH A 0.035 CROSSING CATHETER. THE .035 WAS THEN REMOVED AND REPLACED WITH A 0.014 CROSSING CATHETER. THE .014 CROSSING CATHETER WAS NOTED TO HAVE RESISTANCE WITH THE HT COMMAND GUIDE WIRE DURING ADVANCEMENT AND REMOVAL. THE GUIDE WIRE AND CROSSING CATHETER WAS REMOVED AS A SINGLE UNIT. THE GUIDE WIRE BLACK POLYMER WAS THEN NOTED TO HAVE BEEN STRIPPED. FLUOROSCOPY CONFIRMED NOTHING WAS LEFT IN THE ANATOMY. ANOTHER NON-ABBOTT GUIDE WIRE 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 22205535 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION. THE COMMAND GUIDE WIRE WAS ADVANCED TO THE LESION WITH A CATHETER FROM ANOTHER MANUFACTURER WITHOUT ISSUE. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER; HOWEVER IT WAS STUCK TO THE COMMAND GUIDE WIRE AND THE DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. A NEW COMMAND GUIDE WIRE AND A NEW CATHETER WERE 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 22169750 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT AN UNKNOWN VESSEL. A 300CM HI-TORQUE (HT) COMMAND ES 14 GUIDEWIRE BROKE INSIDE A NON-ABBOTT MICROCATHETER. THE HT COMMAND GUIDEWIRE AND MICROCATHETER WERE REMOVED AS ONE PIECE. A NEW HT COMMAND 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 22144510 ↗