HI-TORQUE COMMAND 2078173Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648176661), received between Mar 2, 2017 and Aug 31, 2026 — classified as 9 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (14 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break; Stretched

  It was reported that the procedure performed was to treat a heavily calcified, right anterior tibial artery that is 100% stenosed. After a microcatheter was advanced to a position proximal to the lesion, an attempt was made to exchange the existing HT Command guide wire for another guide wire. After removal, the tip appeared unraveled and elongated. A new Command 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 50526613 ↗
• MalfunctionJul 14, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816759 ↗
• MalfunctionFeb 16, 2026Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH 80% STENOSIS. THE COMMAND GUIDE WIRE HAD DIFFICULTY BEING ADVANCED TO THE INTENDED LOCATION. THE WIRE WAS REMOVED FROM THE ANATOMY AND DELAMINATION OF THE BLACK POLYMER COATING WAS SEEN. A NEW COMMAND 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 24344983 ↗
• MalfunctionSep 5, 2025Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POSTERIOR TIBIAL ARTERY WITH SEVERE CALCIFICATION AND MILD TORTUOSITY. THE COMMAND GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED THROUGH THE INTRODUCER SHEATH AND GUIDING CATHETER; HOWEVER THE WIRE WOULD NOT CROSS DUE TO THE ANATOMY. UPON REMOVAL OF THE GUIDE WIRE, A SEPARATION OCCURRED INSIDE THE GUIDING CATHETER. THE SEPARATED PIECE REMAINED IN THE GUIDING CATHETER AND THE DEVICES WERE REMOVED TOGETHER AS A UNIT. A NEW COMMAND 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 22980089 ↗
• MalfunctionJul 11, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, RIGHT SUPERIOR FEMORAL ARTERY THAT IS 100% STENOSED. AFTER CROSSING THE LESION, A NON-ABBOTT GUIDE WIRE WAS EXCHANGED FOR A 300CM HT (HI-TORQUE) COMMAND GUIDE WIRE. DURING ADVANCEMENT OF THE HT COMMAND GUIDE WIRE, RESISTANCE WAS MET WITH THE MICROCATHETER CAUSING EXCESSIVE FORCE TO BE APPLIED. THE MICROCATHETER WAS REMOVED, SOAKED IN SALINE, AND REINSERTED INTO THE PATIENT WHEN A KINK WAS NOTED ON THE SHAFT OF THE HT COMMAND GUIDE WIRE. DURING REMOVAL OF THE HT COMMAND GUIDE WIRE, RESISTANCE WITH THE MICROCATHETER WAS NOTED, AND THE HT COMMAND GUIDEWIRE WAS REMOVED AS A SINGLE UNIT. AN UNSPECIFIED 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 22481110 ↗
• MalfunctionApr 1, 2025Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO FILING THE INITIAL REPORT, THE UNSPECIFIED BALLOON CATHETER WAS CLARIFIED TO BE A JADE BALLOON CATHETER. ADDITIONALLY, THE JADE BALLOON WAS THOUGHT TO HAVE POSSIBLY CAUSED/CONTRIBUTED TO THE COMMAND WIRE SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21747011 ↗
• MalfunctionFeb 14, 2025Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE HT COMMAND WAS ADVANCED TO THE LESION AND USED WITH MULTIPLE DEVICES. A BALLOON CATHETER WAS ATTEMPTED TO BE ADVANCED OVER THE GUIDE WIRE HOWEVER RESISTANCE WAS MET AND THE BALLOON CATHETER BECAME STUCK ON THE WIRE. THE BALLOON CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER. OUTSIDE THE ANATOMY WHILE REMOVING THE BALLOON CATHETER IT WAS NOTED THE GUIDE WIRE COATING SEPARATED. NO PORTION OF THE GUIDE WIRE REMAINED IN THE PATIENT ANATOMY. 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 21384748 ↗
• MalfunctionFeb 10, 2025Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE RIGHT POPLITEAL ARTERY WITH HEAVY CALCIFICATION. THE HT COMMAND 300CM GUIDE WIRE (GW) WAS INSERTED IN A SHEATH AND WAS ATTEMPT TO BE ADVANCED TO CROSS THE TARGET LESION; HOWEVER, THE GW FAILED TO CROSS DUE THE ANATOMY. THEREFORE, THE GW WAS REMOVED FROM THE PATIENT AND THE POLYMER COATING WAS NOTED TO HAVE PEELED BACK FROM THE GW. ANOTHER HT COMMAND GUIDE WIRE (GW) WAS USED TO CONTINUE THE PROCEDURE. 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 21351407 ↗
• InjuryJan 10, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. THE CREATION OF A FISTULA BETWEEN THE POSTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL VEIN THROUGH THE USE OF A LIMFLOW SYSTEM WAS ATTEMPTED; HOWEVER DUE TO THE CALCIUM THE GUIDEWIRE FOR AN ORBITAL ATHERECTOMY COULD NOT CROSS THE LESION. THEREFORE A 300CM HT COMMAND 14 GUIDEWIRE WAS ADVANCED INTO THE ANATOMY HOWEVER WAS NOTED TO SEPARATE IN THE OCCLUDED LESION. THE SEPARATED PORTION WAS LEFT IN THE ANATOMY AND THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS PROVIDED: THE TIP OF THE 300CM HT COMMAND 14 GUIDEWIRE WAS NOTED TO SEPARATE IN THE OCCLUDED LESION DUE TO DEVICE INTERACTION WITH THE ORBITAL ATHERECTOMY DEVICE. THE SEPARATED PORTION WAS LEFT IN THE OCCLUDED VESSEL WHERE SNARING WAS NOT POSSIBLE AND IT WOULD CAUSE NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21123478 ↗
• MalfunctionOct 21, 2024Peeled/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 DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) COMMAND 14 GUIDE WIRE FAILED TO CROSS DUE TO A RESISTANCE WITH A MICROCATHETER AND GOT STUCK. THE HT COMMAND GUIDE WIRE HAD RESISTANCE WHEN REMOVING FROM THE MICROCATHETER BUT WAS REMOVED INDEPENDENTLY. THE COATING WAS NOTED TO BE PEELING OFF. ANOTHER HT COMMAND 14 GUIDE WIRE WAS ATTEMPTED TO BE USED BUT WITH THE SAME ISSUES WITH THE MICROCATHETER. POSSIBLE ISSUE WAS THE MICROCATHETER SO THE DEVICE WAS REPLACED AND ANOTHER HT COMMAND 14 GUIDE WIRE WAS USED COMPLETING 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 20500612 ↗
• MalfunctionOct 21, 2024Peeled/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 DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) COMMAND 14 GUIDE WIRE FAILED TO CROSS DUE TO A RESISTANCE WITH A MICROCATHETER AND GOT STUCK. THE HT COMMAND GUIDE WIRE HAD RESISTANCE WHEN REMOVING FROM THE MICROCATHETER BUT WAS REMOVED INDEPENDENTLY. THE COATING WAS NOTED TO BE PEELING OFF. ANOTHER HT COMMAND 14 GUIDE WIRE WAS ATTEMPTED TO BE USED BUT WITH THE SAME ISSUES WITH THE MICROCATHETER. POSSIBLE ISSUE WAS THE MICROCATHETER SO THE DEVICE WAS REPLACED AND ANOTHER HT COMMAND 14 GUIDE WIRE WAS USED COMPLETING 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 20499521 ↗
• MalfunctionJun 3, 2024Difficult 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 ANTERIOR TIBIAL ARTERY. THE COMMAND GUIDE WIRE WAS USED WITH A BALLOON CATHETER AND A DRUG COATED BALLOON CATHETER. DURING REMOVAL, RESISTANCE WAS MEET BETWEEN THE COMMAND GUIDE WIRE AND GUIDING CATHETER. OUTSIDE THE ANATOMY THE COATING WAS NOTED TO BE MISSING. ANOTHER COMMAND GUIDE WIRE WAS USED HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMMAND GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448199 ↗
• InjurySep 27, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE RIGHT TIBIAL ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE HI-TORQUE (HT) COMMAND 14 GUIDE WIRE FAILED TO CROSS DUE TO THE ANATOMY AND SEPARATED IN THE ANATOMY, PROXIMAL TO THE RIGHT ANTERIOR TIBIAL ARTERY. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 17824893 ↗
• InjuryJul 7, 2023Material Separation; Material Separation

  MEDWATCH FORM WAS RECEIVED AND REPORTED: DESCRIBE THE EVENT OR PROBLEM: AS DEVICE WAS BEING WITHDRAWN FROM THE PATIENT, A PIECE OF THE HYDROPHILIC COATING CAME OFF THE DEVICE AND RETAINED IN THE VESSEL NEAR THE FOOT. PHYSICIAN WAS ABLE TO RETRIEVE THE PIECE IN ITS ENTIRETY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : LEFT LEG ANGIOGRAM INTERVENTION AND DEBRIDEMENT. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). SUBSEQUENT TO THE INITIAL REPORTED INFORMATION ON THE MEDWATCH FORM, THE ACCOUNT STATED THAT A SNARE DEVICE WAS USED TO REMOVED THE SEPARATED COATING AND NOTHING WAS LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278631 ↗
• InjuryJun 28, 2023Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE POSTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY AND 100% STENOSIS. THE HT COMMAND 14 GUIDE WIRE CROSSED THE LESION FROM THE ANTERIOR TIBIAL ARTERY (ATA) VIA RETROGRADE APPROACH, BUT AN UNSPECIFIED BALLOON CATHETER FAILED TO CROSS THE LESION. THEREFORE, THE HT COMMAND 14 WAS BEING REMOVED, BUT THE TIP BECAME STUCK IN THE LESION. A NON-ABBOTT MICRO CATHETER WAS REPLACED WITH ANOTHER .018 NON-ABBOTT CATHETER TO REMOVE THE GUIDE WIRE. FORCE WAS APPLIED; HOWEVER, THE TIP WAS SEPARATED AND REMAINS IN THE PATIENT'S ANATOMY. THE TIP WAS POSSIBLY EMBEDDED IN THE LESION, BUT THIS COULD NOT BE CONFIRMED. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 17219755 ↗
• MalfunctionJun 19, 2023Difficult 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 LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MILD CALCIFICATION AND NO TORTUOSITY. THE HI-TORQUE (HT) COMMAND 14 GUIDE WIRE WAS PASSED THROUGH AN ARMADA 18 BALLOON, HOWEVER, THERE WAS RESISTANCE. THE GUIDE WIRE WAS TAKEN OUT AND THE BALLOON WAS FLUSHED. THE GUIDE WIRE WAS WIPED WITH SALINE TO LUBRICATE THE DEVICE AND WAS ADVANCED BACK INTO THE BALLOON BUT STILL WITH LOTS OF RESISTANCE. THERE WAS LOTS OF RESISTANCE WHEN THE GUIDE WIRE WAS REMOVED AGAIN AND THE WIRE WAS NOTED TO BE COMPLETELY CURLED UP AND KINKED. THE WIRE WAS REMOVED INDEPENDENTLY. ANOTHER GUIDE WIRE WAS USED WITH THE SAME ARMADA 18 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 17153564 ↗
• MalfunctionMay 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL POSTERIOR TIBIAL ARTERY WITH TORTUOSITY AND CHRONIC TOTAL OCCLUSION (CTO). THE COMMAND GUIDE WIRE WAS THROUGH A NON-ABBOTT CATHETER; HOWEVER, THE GUIDE WIRE BECAME STUCK INSIDE THE CATHETER AFTER CROSSING THE LESION. THE COMMAND GUIDE WIRE AND CATHETER WERE REMOVED TOGETHER. ANOTHER WIRE WAS OPENED TO ATTEMPT TO CROSS AGAIN; HOWEVER THEY WERE UNABLE TO CROSS THE LESION AND THE CASE WAS FINISHED UNSUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A DELAY IN THE CASE; HOWEVER THERE WAS NO IMPACT TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887513 ↗
• MalfunctionMar 29, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE HT COMMAND 14 GUIDE WIRE WAS NOT ABLE TO ADVANCE OVER THE UNSPECIFIED INTRAVASCULAR ULTRASOUND CATHETER. RESISTANCE DURING REMOVAL WAS NOTED. ANOTHER COMMAND 14 GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639362 ↗
• MalfunctionDec 19, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT AFTER UNSEALING THE PACKAGING AND REMOVING THE COMMAND GUIDE WIRE, THE TIP WAS NOTED TO BE COLLAPSED. THE CORE AND THE COILS WERE IN TACT. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER COMMAND GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE POLYMER COATING OF THE WIRE WAS SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008612 ↗
• InjurySep 24, 2022Entrapment of Device; Material Separation; Difficult to Advance; Entrapment of Device; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE HT-COMMAND 14 GUIDEWIRE (GW) WAS ATTEMPTED TO BE ADVANCED TO THE ANTERIOR TIBIAL ARTERY (ATA) WITH MODERATE CALCIFICATION, BUT THE GW STRAYED DURING ADVANCEMENT. RESISTANCE WAS NOTED DUE TO AN ACCUMULATION OF TORQUE AT THE TIP OF THE DEVICE AND THE TIP SEPARATED APPROXIMATELY 3 CM PROXIMAL TO THE TIP. UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE SEPARATED PORTION OF THE GW. THE SEPARATED GW TIP WAS TRAPPED IN THE NARROW VESSEL AND REMAINS IN THE OCCLUSION. THE TARGET LESION WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15476710 ↗
• InjuryApr 14, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DORSALIS PEDIS ARTERY. THE HT COMMAND 14 GUIDE WIRE WAS USED AND TORQUED IN THE NON-ABBOTT MICRO CATHETER FOR FOUR HOURS. IT WAS NOTED THE TIP OF THE GUIDE WIRE SEPARATED AND WAS ATTEMPTED TO BE SNARED; HOWEVER, WAS UNSUCCESSFUL. THE TIP WAS EMBEDDED INTO THE VESSEL WALL. IT WAS NOTED RESISTANCE WAS FELT DURING ADVANCEMENT WITH THE UNSPECIFIED MICRO CATHETER AND ANATOMY. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14112017 ↗
• InjuryFeb 23, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT CHRONIC LIMB ISCHEMIA. THE TIP OF THE HT COMMAND GUIDE WIRE SEPARATED DURING THE PROCEDURE. THE TIP WAS REMOVED VIA SNARE FROM THE ANATOMY. IT WAS NOTED IT TOOK AN EXTRA 15 MINUTES TO REMOVE THE SEPARATED TIP; HOWEVER, THE EXTRA TIME DID NOT CAUSE AN ADVERSE EFFECT. ANOTHER SAME SIZE COMMAND GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585593 ↗
• MalfunctionDec 16, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH MONCKEBERG SCLEROSIS IN THE AORTA WITH RUNOFF IN PERIPHERAL VESSELS AND HEAVY CALCIFICATION. THAT DAY, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT POPLITEAL AND RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) CONTAINING THIS HEAVY/JAGGED CALCIFICATION. USING A 6 FRENCH SHEATH, AN HT COMMAND GUIDE WIRE ADVANCED THROUGH THE ACUTE/STEEP ILIAC BIFURCATION WITHOUT ISSUES. FOLLOWING, AN ARMADA 18 AND AN ARMADA 35 BALLOON DILATATION CATHETER HAD ADVANCED WITHOUT ISSUES. UPON FIRST INFLATION ATTEMPT, BOTH BALLOONS HAD RUPTURED BELOW RATED BURST PRESSURE DUE TO THE HEAVY, JAGGED CALCIFICATION. THE CATHETERS WERE REMOVED WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THE FIRST SUPERA STENT WAS SUCCESSFULLY IMPLANTED. FOLLOWING, A SECOND SUPERA STENT DELIVERY ADVANCED WITH DIFFICULTY/RESISTANCE NOTED WITH THE COMMAND WIRE, ONCE AT THE STEEP BIFURCATION. THE SUPERA HAD THEN BECOME STUCK ON THE WIRE AND WAS UNABLE TO ADVANCE OR BE REMOVED. BOTH WERE REMOVED AS A SINGLE UNIT (THE WIRE AND SUPERA SDS). ANOTHER DEVICE WAS USED IN REPLACEMENT, COMPLETING THE PROCEDURE, WITHOUT FURTHER ISSUES NOTED. THERE WERE NO ADVERSE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019367 ↗
• MalfunctionNov 8, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER THE HT COMMAND GUIDE WIRE WAS REMOVED FROM THE PACKAGING IT WAS OBSERVED THAT THE COATING WAS NOTED TO BE PEELED OFF FROM THE DEVICE. ANOTHER GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770921 ↗
• InjuryAug 10, 2020Entrapment of Device; Failure to Advance; Deformation Due to Compressive Stress; Material Split, Cut or Torn; Entrapment of Device; Failure to Advance; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. THE HT COMMAND GUIDE WIRE WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE DISTAL END OF THE GUIDE WIRE BECAME KINKED AND THE POLYMER WAS NOTED TO BE TORN AT THE DISTAL END. THE GUIDE WIRE HAD DIFFICULTY DURING REMOVAL SO A MICROCATHETER WAS INSERTED AND USED TO REMOVE THE GUIDE WIRE. THERE WAS NO PORTION OF THE POLYMER LEFT IN THE PATIENT. A NEW COMMAND GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10388091 ↗