HI-TORQUE COMMAND 1013753Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648211980), received between Aug 1, 2019 and Mar 11, 2026 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THE PROCEDURE WAS TO IMPLANT A CARDIOMEMS SENSOR IN A PULMONARY ARTERY. TWO COMMAND 18 LT GUIDE WIRES WERE USED HOWEVER DURING REMOVAL, RESISTANCE WAS MET WITH THE CARDIOMEMS DELIVERY CATHETER. FORCE WAS APPLIED IN THE ATTEMPTS TO REMOVE THE GUIDE WIRE AND ONCE REMOVED FROM THE ANATOMY, IT WAS NOTED THE POLYMER COATING ON THE GUIDE WIRES WERE PEELING [DEGLOVED] AND TWISTED. 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 24567478 ↗
• MalfunctionMar 11, 2026Peeled/Delaminated; Difficult to Remove; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  IT WAS REPORTED THE PROCEDURE WAS TO IMPLANT A CARDIOMEMS SENSOR IN A PULMONARY ARTERY. TWO COMMAND 18 LT GUIDE WIRES WERE USED HOWEVER DURING REMOVAL, RESISTANCE WAS MET WITH THE CARDIOMEMS DELIVERY CATHETER. FORCE WAS APPLIED IN THE ATTEMPTS TO REMOVE THE GUIDE WIRE AND ONCE REMOVED FROM THE ANATOMY, IT WAS NOTED THE POLYMER COATING ON THE GUIDE WIRES WERE PEELING [DEGLOVED] AND TWISTED. 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 24567394 ↗
• InjuryDec 10, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID POPLITEAL ARTERY WITH HEAVY CALCIFICATION, MODERATE CALCIFICATION AND 90% STENOSIS. THE COMMAND 18 GUIDE WIRE WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE HIGH CALCIFICATION. AFTER VARIOUS ATTEMPTS, THE TIP OF THE GUIDE WIRE SEPARATED AND REMAINED IN THE CALCIFICATION. IT WAS NOT POSSIBLE TO REMOVE THE TIP VIA AN UNSPECIFIED METHOD. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20896745 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  SUBSEQUENTLY, AFTER INITIAL WAS FILED IT WAS REPORTED THAT THE HT COMMAND GUIDE WIRE TIP WAS NOTED TO BE SEPARATED DUE TO SUCTION WAS DRAWN BACK ON THE CATHETER AND THE TIP OF THE WIRE WAS NOTED IN THE HEPARINIZED SALINE SYRINGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606185 ↗
• InjuryMay 31, 2023Difficult or Delayed Positioning; Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult or Delayed Positioning; Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THE COMMAND 18 GUIDE WIRE WAS NOT FLUSHED WITH HEPARINIZED SALINE PRIOR TO ENTERING THE PATIENT'S ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 17034080 ↗
• MalfunctionMay 19, 2023Off-Label Use; Difficult to Remove; Material Separation; Difficult to Advance; Off-Label Use; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE LEFT PULMONARY ARTERY. AN HT COMMAND 18 GUIDE WIRE (GW) WAS IN PLACE AND A CARDIOMEMS SENSOR WAS ADVANCED. DURING REMOVAL, THE CARDIOMEMS SENSOR MET RESISTANCE WITH THE COMMAND 18 GUIDE WIRE AND COULD NOT BE REMOVED FROM THE GUIDE WIRE. THE CARDIOMEMS SENSOR AND THE GUIDE WIRE WERE REMOVED TOGETHER AS A SINGLE UNIT. OUTSIDE OF THE ANATOMY, SIGNIFICANT EFFORT WAS TAKEN TO REMOVE THE GUIDEWIRE FROM THE CARDIOMEMS DELIVERY CATHETER, ONCE REMOVED, THE DISTAL END OF THE GUIDEWIRE WAS NOTED AS SEPARATED AND A PIECE OF THE GUIDEWIRE HAD TO BE MANUALLY REMOVED FROM THE DELIVERY CATHETER. A NEW GUIDE WIRE AND CARDIOMEMS SENSOR WERE USED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16966440 ↗
• MalfunctionMay 17, 2023Peeled/Delaminated; Off-Label Use; Difficult to Advance; Peeled/Delaminated; Off-Label Use; Difficult to Advance

  IT WAS REPORTED THAT THE DURING A CARDIOMEMES PROCEDURE THE DELIVERY SYSTEM HAD RESISTANCE DURING ADVANCEMENT WITH TWO COMMAND 18 GUIDE WIRES AND A STEELCORE GUIDE WIRE. THE TWO COMMAND 18 GUIDE WIRES WERE NOTED TO HAVE COATING PEELED ONCE OUTSIDE THE ANATOMY. THE CASE WAS ABORTED DUE TO PATIENT CONDITION EXPERIENCING CRAMPING IN LOWER LEG; HOWEVER, IT WAS NOTED PER THE PHYSICIAN THAT THE GUIDE WIRES DID NOT CAUSE OR CONTRIBUTE TO THE CRAMPING OF THE LOWER LEG. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947993 ↗
• MalfunctionMay 17, 2023Peeled/Delaminated; Off-Label Use; Difficult to Advance; Peeled/Delaminated; Off-Label Use; Difficult to Advance

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED THE ACCOUNT NOTED IT WAS THE POLYMER COATING THAT WAS PEELING FROM BOTH COMMAND 18 GUIDE WIRES WAS AT THE CORE; HOWEVER, NOTHING WAS LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947987 ↗
• MalfunctionNov 22, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY TO THE POPLITEAL ARTERY. DURING INSERTION OF THE HT COMMAND 18 GUIDEWIRE (GW) INTO THE 21 GAUGE NEEDLE, SOME OF THE GW COATING WAS NOTED TO CAME OFF. THE PHYSICIAN CONFIRMED NO COATING CAME OFF IN THE PATIENT ANATOMY, AS ONLY A PORTION OF THE GUIDEWIRE HAD ENTERED THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. THE PROCEDURE WAS CONTINUED WITH A STEELCORE GW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841215 ↗
• MalfunctionOct 12, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE COMMAND 18 GUIDE WIRE WAS ADVANCED, BUT RESISTANCE WAS FELT WITH THE GUIDING CATHETER AND THE GUIDE WIRE SEPARATED IN TWO PIECES. THE GUIDING CATHETER WITH THE SEPARATED GUIDE WIRE WERE WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ISSUE. A NEW GUIDING CATHETER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. 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 15592344 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT WAS A CARDIOMEMS PROCEDURE. WHEN THE CARDIOMEMS WAS BEING ADVANCED OVER THE HI-TORQUE COMMAND 18 GUIDEWIRE THRU THE RIGHT VENTRICLE, THE PATIENT'S HEART RATE DROPPED TO ~25 BEATS PER MINUTE (BPM). IT WAS SUGGESTED THAT THE GUIDEWIRE AND/OR DELIVERY CATHETER PERTURBED THE PATIENT'S RIGHT BUNDLE BRANCH AND HEART BLOCK OCCURRED. ISUPREL WAS GIVEN TO INCREASE HEART RATE BUT DID NOT WORK. CARDIOMEMS WAS ADVANCED INTO THE PULMONARY ARTERY AND DEPLOYED SUCCESSFULLY. AN ELECTROPHYSIOLOGIST CAME INTO THE ROOM AND A TEMPORARY PACING WIRE WAS PLACED INTO THE RIGHT VENTRICLE, PATIENT WAS THEN BEING PACED AT 70 BPM. RATHER THAN RE-FLOATING THE SWAN INTO THE PULMONARY ARTERY PAST THE PACING WIRE, CARDIOMEMS WAS SUCCESSFULLY CALIBRATED TO THE INITIAL RIGHT HEART CARDIAC (RHC) PRESSURES FROM THE PULMONARY ARTERY. PATIENT IS STABLE AND WAS SENT TO THE INTENSIVE CARE UNIT OVER THE WEEKEND FOR MONITORING DUE TO THE HEART BLOCK INSTEAD OF BEING OUTPATIENT AND ENDED UP RECEIVING A PERMANENT PACEMAKER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia

  MAUDE report 15267397 ↗
• MalfunctionFeb 4, 2022Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A COMMAND 18 GUIDE WIRE WAS ADVANCED IN THE VESSEL WITHOUT RESISTANCE, FOLLOWED BY AN ARMADA 18 BALLOON CATHETER. WHEN THE COMMAND GUIDE WIRE WAS BEING REMOVED THERE WAS RESISTANCE WITH THE BALLOON CATHETER. BOTH DEVICES HAD TO BE REMOVED AS ONE UNIT. ONCE OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT COATING OF THE GUIDE WIRE HAD PEELED OFF THE TIP OF THE GUIDE WIRE. THE ARMADA 18 BALLOON CATHETER WAS FLUSHED, AND THE SEPARATED COATING WAS FLUSHED COMPLETELY. THERE WAS NO COATING IN THE PATIENT'S ANATOMY PRESENT. A STEELCORE GUIDE WIRE WAS USED WITH THE SAME ARMADA 18 BALLOON CATHETER WITHOUT ISSUE. THERE WAS NO ISSUE WITH THE ARMADA 18 BALLOON 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 13458086 ↗
• MalfunctionJul 1, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT A CARDIOMEMS DEVICE, A STEELCORE 18 LT GUIDE WIRE FACED RESISTANCE WITH THE OTHER DEVICE DURING ADVANCEMENT. THE GUIDE WIRE WAS REPLACED BY A COMMAND 18 LT GUIDE WIRE, BUT THE DEVICE COULD NOT BE ADVANCED OR REMOVED WITH THIS GUIDE WIRE. ANOTHER CARDIOMEMS DEVICE AND AN UNSPECIFIED STEELCORE GUIDE WIRE WERE USED TO SUCCESSFULLY 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 12101045 ↗
• MalfunctionNov 26, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE COMMAND GUIDE WIRE BECAME STUCK WITH THE DELIVERY CATHETER OF THE CARDIOMEMS HF (HEART FAILURE) SYSTEM DURING THE PROCEDURE. THE CARDIOMEMS SYSTEM COULD NOT BE ADVANCED PAST THE RIGHT VENTRICLE. THE COMMAND GUIDE WIRE WAS REMOVED WITH THE DELIVERY SYSTEM AND THE SHEATH. 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 Consequences Or Impact To Patient

  MAUDE report 10909052 ↗
• InjuryNov 9, 2020Product Quality Problem; Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn; Product Quality Problem; Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE HI-TORQUE COMMAND 18 LT GUIDEWIRE WAS USED TO PLACE A CARDIOMEMS SENSOR. RESISTANCE WAS NOTED WITH THE CATHETER DURING ADVANCEMENT AND REMOVAL. WHEN THE WIRE WAS PULLED OUT OF THE CATHETER, IT WAS ROUGH AND FRAYED. PER THE PHYSICIAN, THE WIRE CAUSED THE CATHETER TO HAVE A CLOT. TREATMENT, IF ANY, WAS NOT REPORTED. THE SENSOR WAS IMPLANTED WITHOUT ISSUE AND IS FUNCTIONING AS IT SHOULD. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO FILING THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED. THE PATIENT DID NOT RECEIVE ADDITIONAL MEDICATION OR TREATMENT DUE TO THE CLOT; HOWEVER, THEIR NORMAL MEDICATION WAS STARTED AGAIN.

  Patient problems: Thrombosis

  MAUDE report 10809486 ↗
• MalfunctionOct 23, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: "ABBOTT VASCULAR HI-TORQUE COMMAND 18 LT GUIDE WIRE BECAME STUCK ON CARDIOMEMS HF SYSTEM. MD CHOSE NOT TO DEPLOY DEVICE". 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 10727920 ↗
• MalfunctionSep 10, 2020Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING THE CARDIOMEMS IMPLANT PROCEDURE, IT WAS NOT POSSIBLE TO ADVANCE THE CARDIOMEMS DELIVERY CATHETER THROUGH THE RIGHT VENTRICULAR OUTFLOW TRACT OVER THE COMMAND 18 GUIDE WIRE. WHEN IT WAS ATTEMPTED TO BRING THE SENSOR BACK THROUGH THE SHEATH, IT COULD NOT BE DIRECTED BACK INTO THE SHEATH. THE SHEATH, DELIVERY CATHETER, AND COMMAND 18 GUIDE WIRE WERE REMOVED FROM THE PATIENT AT THE SAME TIME WITH THE SENSOR OUTSIDE OF THE SHEATH. THE PROCEDURE WAS ABORTED. 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 10514746 ↗
• MalfunctionAug 3, 2020Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO PLACE A CARDIOMEMS SENSOR USING A HITORQUE COMMAND 18 GUIDE WIRE. THE GUIDE WIRE WAS INSERTED INTO THE LOWER LEFT LOBE OF THE PULMONARY ARTERY. THE SENSOR WAS DEPLOYED WITHOUT INCIDENT, HOWEVER; RESISTANCE WAS FELT WHEN REMOVING THE GUIDE WIRE OUT OF THE DELIVERY CATHETER. THE DELIVERY CATHETER AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10358257 ↗
• MalfunctionJul 30, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO USE, A CARDIOMEMS SENSOR DELIVERY CATHETER WAS ADVANCED OVER A HI-TORQUE COMMAND 18 GUIDE WIRE, BUT RESISTANCE WAS FELT BETWEEN THE TWO DEVICES DURING ADVANCEMENT AND REMOVAL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10344393 ↗
• InjuryJul 24, 2020Product Quality Problem; Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn; Product Quality Problem; Difficult to Remove; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO PLACE A CARDIOMEMS SENSOR USING A HITORQUE COMMAND LT GUIDE WIRE. AS THE SENSOR WAS BEING ADVANCED OVER THE GUIDE WIRE, IT WAS NOTED THAT IT COULD NOT ADVANCE PAST THE RIGHT VENTRICULAR (RV). THE GUIDE WIRE WAS NOTED AS FEELING GRITTY OR STICKY. BOTH THE SENSOR AND GUIDE WIRE WERE REMOVED TOGETHER. TWO SECTIONS OF COATING WERE MISSING THAT WERE APPROXIMATELY 5CM LONG FROM THE WIRE. IT WAS NOTED THAT THE COATING WOULD GET STUCK WHILE RETRACTING THE WIRE OUT OF THE SENSOR DELIVERY CATHETER. IT IS UNKNOWN IF ANY OF THE GUIDE WIRE COATING WAS LEFT IN THE PATIENT. IT WAS DECIDED TO USE A STEELCORE GUIDE WIRE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH A 30 MINUTE DELAY WAS ADDED TO PROCEDURE TIME, THE PHYSICIAN DID NOT DEEM IT CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10319877 ↗
• MalfunctionJul 16, 2020Product Quality Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Product Quality Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT PULMONARY CORONARY ARTERY. A CARDIOMEMS SENSOR DELIVERY CATHETER AND A COMMAND 18 GUIDE WIRE WERE ADVANCED, BUT THE GUIDE WIRE FELT RESISTANCE WITH THE DELIVERY CATHETER DURING ADVANCEMENT. THE PHYSICIAN USED FORCE TO REACH THE INTENDED ANATOMY. THE GUIDE WIRE WAS DIFFICULT TO REMOVE AS IT FELT RESISTANCE WITH THE DELIVERY CATHETER, SO THEY WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS THEN COMPLETED, AND THE HYDROPHILIC COATING MAY HAVE LOST ITS INTEGRITY AT SOME 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 10284122 ↗
• MalfunctionJun 18, 2020Peeled/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

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER DIFFICULTY ADVANCING THE DEVICE WAS EXPERIENCED, FORCE WAS APPLIED TO ADVANCE THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171719 ↗
• InjuryAug 1, 2019Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE LEG ATHERECTOMY PROCEDURE WAS TO TREAT A LESION IN THE PERONEAL MEDIAL ARTERY. RESISTANCE WAS NOTED DURING RETRIEVAL OF A COMMAND GUIDE WIRE FROM A NON-ABBOTT ATHERECTOMY DEVICE. FORCE WAS APPLIED AND THE TIP OF THE COMMAND GUIDE WIRE SEPARATED. THE SEPARATED TIP WENT DEEP INTO A SMALL COLLATERAL OF THE PERONEAL ARTERY AND THE DECISION WAS MADE NOT TO RETRIEVE IT. THE PHYSICIAN DOES NOT EXPECT COMPLICATIONS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8852007 ↗