HI-TORQUE STEELCORE 1003282Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648013959), received between Mar 8, 2017 and Aug 31, 2026 — classified as 1 death, 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Break; Stretched

  It was reported that upon removing the Steelcore guide wire from the packaging, the tip was noted to be unraveled "[broken]". Therefore there was no device use or patient involvement. Another device was used to complete the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525252 ↗
• InjuryAug 31, 2026Entrapment of Device

  It was reported that this was a CardioMEMS sensor implant procedure. The Steelcore guide wire was advanced through the left pulmonary artery and the CardioMEMS sensor was deployed. The delivery system was attempted to be removed; however it was noted that the Steelcore guide wire was engaging with the distal loop of the sensor and moving it. The Swan Ganz catheter used previously in the procedure was advanced with a balloon to try to retract the wire while blocking the sensor from moving backwards; however this was unsuccessful. A glide catheter was then inserted to disengage and retract the wire. This was successful and the patient remained stable with no complications. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524880 ↗
• MalfunctionJul 8, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750835 ↗
• MalfunctionJun 5, 2026Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO IMPLANT A CARDIOMEMS SENSOR. THE STEELCORE GUIDE WIRE WAS ADVANCED INTO THE PATIENT FOLLOWED BY THE CARDIOMEMS DELIVERY CATHETER OVER THE WIRE. PRIOR TO DEPLOYMENT OF THE SENSOR, AN ATTEMPT WAS MADE TO RETRACT THE GUIDEWIRE INTO THE DELIVERY SYSTEM HOWEVER IT WAS NOTED THE WIRE WOULD NOT RETRACT. AFTER MANIPULATION, THE WIRE WAS ABLE TO BE COMPLETELY REMOVED AND A NEW STEELCORE WIRE WAS ADVANCED. THE SAME ISSUE THEN OCCURRED WITH THE SECOND WIRE, WITH RESISTANCE ENCOUNTERED WHEN ATTEMPTING TO RETRACT THE WIRE BACK INTO THE DELIVERY SYSTEM. AT THAT POINT, THE PHYSICIAN¿S BECAME CONCERNED THERE MAY BE AN ISSUE WITH THE DELIVERY SYSTEM ITSELF; THEREFORE THE DECISION WAS MADE TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE WIRE THAT REMAINED STUCK WITHIN THE DELIVERY SYSTEM. INCREASED RESISTANCE WAS ENCOUNTERED AT THE SHEATH SITE DURING REMOVAL. AFTER ADDITIONAL MANIPULATION, THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED THROUGH THE SHEATH WITH THE GUIDEWIRE STILL STUCK AT THE DISTAL TIP. THE SENSOR APPEARED COMPROMISED, SO A NEW DELIVERY SYSTEM WAS OPEN AND UTILIZED. NO ISSUES WERE ENCOUNTERED WITH THE SECOND DELIVERY SYSTEM OR NEW GUIDE WIRE. THE SECOND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410365 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT WHEN THE STEELCORE GUIDE WIRE WAS REMOVED FROM THE PACKAGING THE TIP WAS UNRAVELED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222601 ↗
• InjuryJan 27, 2026Entrapment of Device

  IT WAS REPORTED THAT THIS WAS A CARDIOMEMS SENSOR IMPLANT PROCEDURE. THE STEELCORE GUIDE WIRE WAS USED IN THE PROCEDURE. AFTER THE SENSOR WAS DEPLOYED AND UPON REMOVAL OF THE DELIVERY CATHETER IT WAS NOTED THAT THE GUIDE WIRE WAS PULLED PROXIMAL INTO THE DELIVERY CATHETER. THE CARDIOMEMS SENSOR WAS MOVING WITH THE WIRE. THE DELIVERY CATHETER WAS REMOVED COMPLETELY, AND A SWAN GANZ CATHETER WAS INSERTED OVER THE GUIDEWIRE IN ORDER TO REMOVE THE STEELCORE WIRE. AN UNSPECIFIED BALLOON WAS INFLATED TO HOLD THE SENSOR IN PLACE AS THE GUIDEWIRE WAS REMOVED. ONCE THE GUIDEWIRE WAS REMOVED THE SWAN GANZ CATHETER WAS USED TO CALIBRATE THE CARDIOMEMS SENSOR AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192842 ↗
• MalfunctionNov 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A CARDIOMEMS HEART FAILURE (HF) SYSTEM WAS DEPLOYED OVER AN UNSPECIFIED HI-TORQUE (HT) STEELCORE 18 GUIDE WIRE IN THE LEFT PULMONARY ARTERY (PA). UPON REMOVAL OF THE HT STEELCORE GUIDE WIRE, THE CARDIOMEMS HF SYSTEM GOT CAUGHT AND WAS PULLED INTO THE PULMONARY ARCH. THE HT STEELCORE GUIDE WIRE WAS ABLE TO BE REMOVED INDEPENDENTLY. A NON-ABBOTT PA CATHETER WAS USED TO RE-ADVANCE [REPOSITION] THE CARDIOMEMS HF SYSTEM. THE CARDIOMEMS WAS PUSHED INTO THE RIGHT PA ; NOT THE DESIRED IMPLANT SITE, WHERE CALIBRATION WAS PERFORMED SUCCESSFULLY. 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 23599988 ↗
• MalfunctionAug 20, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT A CARDIOMEMS HEART FAILURE (HF) SYSTEM WAS USED TOGETHER WITH AN UNSPECIFIED 0.018" STEELCORE GUIDE WIRE. THE STEELCORE GUIDE WIRE WAS INSERTED THROUGH A PREPARED UNSPECIFIED PULMONARY ARTERY (PA) WEDGE-PRESSURE CATHETER, TO THE VESSEL. THE PA WEDGE CATHETER WAS REMOVED AND A CARDIOMEMS HF SYSTEM WAS ADVANCED OVER THE STEELCORE GUIDE WIRE. AS THE CATHETER WAS ADVANCING FROM THE RIGHT VENTRICLE (RV) TO THE PA, THE STEELCORE GUIDE WIRE GOT CAUGHT/PINNED DUE TO PATIENT ANATOMY. AN ATTEMPT TO REMOVE THE SENSOR WAS UNSUCCESSFUL AND THE GUIDE WIRE WAS ADVANCED TO THE PA TO THE SELECTED VESSEL BUT FAILED TO CROSS DUE TO ANATOMY. AN UNSPECIFIED 0.014" GUIDE WIRE WAS USED WITH THE PA WEDGE CATHETER TO HELP WITH TRACKING. THE UNSPECIFIED 0.014" GUIDE WIRE WAS REMOVED AND A PA WEDGE CATHETER WAS ADVANCED OVER THE REINSERTED STEELCORE GUIDE WIRE. THE CARDIOMEMS WAS DEPLOYED WITHOUT INCIDENT. THE DELIVERY CATHETER AND GUIDE WIRE WERE REMOVED WITH THE HELP OF THE BALLOON OF THE WEDGE CATHETER. 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 22854200 ↗
• MalfunctionJul 17, 2025Break; Stretched; Break; Stretched

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, THE TIP COILS OF THE SECOND HT STEELCORE GUIDE WIRE WERE NOTED TO BE STRETCHED WITH THE CORE INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532895 ↗
• MalfunctionJul 17, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT SUPERFICIAL FEMORAL ARTERY. DURING PREPARATION AND UPON OPENING THE PACKAGE OF A 300CM HI-TORQUE (HT) STEELCORE GUIDEWIRE, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS UNRAVELED AND HELD TOGETHER BY THE TIP COILS AND IN ONE PIECE. THE GUIDEWIRE WAS NOT USED IN THE PATIENT AND DISCARDED. A SECOND HT STEELCORE GUIDEWIRE OF THE SAME LOT WAS USED, AND DURING THE PROCEDURE VIA ANGIOGRAPHY, THE TIP WAS OBSERVED TO ALSO BE UNRAVELED AND HELD TOGETHER BY THE TIP COILS. THE PROCEDURE WAS ABLE TO BE COMPLETED AND THE SECOND HT STEELCORE GUIDEWIRE WAS REMOVED IN ONE PIECE. IN ADDITION TO THE USED HT STEELCORE GUIDEWIRE, THE REMAINING UNOPENED HT STEELCORE GUIDEWIRES OF THE SAME LOT WILL BE RETURNING. 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 22532888 ↗
• MalfunctionJul 9, 2025Break; Stretched; Break; Stretched

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, RETURNED DEVICE ANALYSIS FOUND THAT THE COILS WERE STRETCHED RATHER THAN A SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460159 ↗
• MalfunctionMay 6, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. ONCE THE .018 HT STEEL CORE GUIDEWIRE WAS PLACED IMAGING WAS PERFORMED AND IT APPEARED THAT THE COIL TIP HAD UNRAVELED AND SEPARATED. THEREFORE, DEVICE WAS REMOVED AND NOTED TO STILL BE INTACT; HOWEVER, SEPARATED FROM THE CORE WITH THE TIP COILS STRETCHED. A NEW HT STEELCORE GUIDEWIRE WAS ADVANCED AND HAD THE SAME ISSUE. 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 21969487 ↗
• MalfunctionMay 6, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY CALCIFIED, SUPERFICIAL FEMORAL ARTERY. ONCE THE .018 HT STEELCORE GUIDEWIRE WAS PLACED, IMAGING WAS PERFORMED AND IT APPEARED THAT THE COIL TIP HAD UNRAVELED AND SEPARATED. THEREFORE, DEVICE WAS REMOVED AND NOTED TO STILL BE INTACT; HOWEVER, SEPARATED FROM THE CORE WITH THE TIP COILS STRETCHED. A NEW HT STEELCORE GUIDEWIRE WAS ADVANCED AND HAD THE SAME ISSUE. 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 21969418 ↗
• MalfunctionApr 23, 2024Break; Off-Label Use; Break; Off-Label Use

  MEDWATCH REPORT #MW5153105 STATES: DURING THE CARDIOMEMS INSERTION PROCEDURE, THE STEELCORE 18 WIRE WAS INSERTED INTO THE LEFT PULMONARY ARTERY. ONCE INSERTED IT WAS NOTED THAT THE WIRE HAD FRACTURED. AT THE END OF THE PROCEDURE THE WIRE WAS REMOVED AND NOTED TO BE FRACTURED, BUT INTACT. NO WIRE WAS LEFT BEHIND IN THE BODY. PRODUCT INFORMATION LISTED BELOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164914 ↗
• MalfunctionMar 1, 2024Break; Off-Label Use; Material Separation; Failure to Advance; Material Too Soft/Flexible; Break; Off-Label Use; Material Separation; Failure to Advance; Material Too Soft/Flexible

  SUBSEQUENT TO THE FINAL MDR REPORT, ADDITIONAL INFORMATION WAS PROVIDED. THE FIRST HT STEELCORE GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED TO THE TARGET SITE; HOWEVER, THE DEVICE WAS UNABLE TO REACH THE TARGET SITE DUE TO THE PATIENT ANATOMY. IT WAS NOTED THAT THE DISTAL END OF THE GUIDEWIRE TIP KINKED. THE DEVICE WAS REMOVED INTACT. THE SECOND STEELCORE GUIDEWIRE WAS THEN ATTEMPTED TO BE ADVANCED TO THE TARGET SITE; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO REACH THE TARGET SITE DUE TO THE PATIENT ANATOMY. IT WAS NOTED THAT THE DISTAL END OF THE GUIDEWIRE TIP APPEARED TO BEND BACK ON ITSELF, BUT REMAINED IN ONE PIECE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY; HOWEVER, UPON REMOVAL, THE PHYSICIAN TOUCHED THE TIP AND IT SEPARATED OUTSIDE 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 18822825 ↗
• InjuryFeb 17, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A CARDIOMEMS PROCEDURE TO PLACE THE CARDIOMEMS SENSOR. THE DEVICE WAS DEPLOYED AND THE CATHETER WAS BEING SWITCHED OUT FOR CALIBRATION WHEN THE PATIENT BEGAN TO COUGH UP BLOOD. IT WAS NOTED THAT A PERFORATION OCCURRED, DUE TO THE STEELCORE GUIDE WIRE WHICH WAS BEING USED. A NON-ABBOTT CATHETER WAS ADVANCED AND INFLATED TO TREAT THE PERFORATION. ANGIOGRAPHY SHOWED NO LEAKS OF CONTRAST IN ANY OF THE VESSELS. THE PATIENT WAS HOSPITALIZED OVER NIGHT FOR OBSERVATION AND THEN SENT HOME THE NEXT DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18728248 ↗
• MalfunctionJan 23, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE AORTA. THE HI-TORQUE (HT) STEELCORE 18 GUIDE WIRE WAS ATTEMPTED TO BE ADVANCED WHEN IT WAS NOTED THAT THE TIP BECAME FRACTURED INSIDE THE CATHETER WHICH POSSIBLY WAS KINKED. UNKNOWN IF THE TIP SEPARATED INTO TWO PIECES SINCE THE ENTIRE GUIDE WIRE AND CATHETER WERE REMOVED FROM THE ANATOMY INTACT. ANOTHER HT STEELCORE 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 18567768 ↗
• InjuryJun 28, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE PULMONARY ARTERY. AFTER A CARDIOMEMS SENSOR WAS IMPLANTED, THE STEELCORE 18 GUIDE WIRE (GW) WAS BEING PULLED BACK WHEN THE PATIENT EXPERIENCED HEMOPTYSIS OR COUGHING UP BLOOD. NO TREATMENT WAS PROVIDED FOR THE BLEEDING AS IT RESOLVED ON ITS OWN. THE PATIENT WAS INTUBATED OVERNIGHT FOR OBSERVATION. THE PATIENT HAD REALLY HIGH PULMONARY ARTERY AND BLOOD PRESSURES DURING THE PROCEDURE. MEDICATIONS WERE GIVEN TO KEEP THE PATIENT SEDATED. THE PATIENT IS CURRENTLY STABLE AND NOT INTUBATED. THE PHYSICIAN STATED HE BELIEVES THE .018 STEELCORE GW PERFORATED THE PULMONARY ARTERY. THE PATIENT HAD NOT BEEN DISCHARGED AS OF (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Perforation of Vessels

  MAUDE report 17221017 ↗
• MalfunctionApr 26, 2022Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVILY CALCIFICATION AND NO TORTUOSITY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HT STEELCORE 18 GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION AND DURING REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY AND THE TIP BECAME KINKED AND UNRAVELED. A SECOND GUIDE WIRE WAS ADVANCED, BUT HAD THE SAME ISSUE. THEREFORE, IT WAS DECIDED TO USE A NON-ABBOTT GUIDE WIRE. 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 14207598 ↗
• MalfunctionApr 26, 2022Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION WITH HEAVILY CALCIFICATION AND NO TORTUOSITY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE HT STEELCORE 18 GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION AND DURING REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY AND THE TIP BECAME KINKED AND UNRAVELED. A SECOND GUIDE WIRE WAS ADVANCED, BUT HAD THE SAME ISSUE. THEREFORE, IT WAS DECIDED TO USE A NON-ABBOTT GUIDE WIRE. 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 14207591 ↗
• MalfunctionJan 27, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED WITH THE PACKAGING UNSEALED OVER A LENGTH OF 10 CM. THE DEVICE WAS NOT USED BECAUSE IT WAS NO LONGER STERILE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374026 ↗
• MalfunctionJan 21, 2022Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A CARDIOMEMS PROCEDURE. THE CARDIOMEMS SENSOR WAS ADVANCED OVER THE HT (HI-TORQUE) STEELCORE 18 GUIDE WIRE AND WENT THROUGH THE SHEATH AND ADVANCED A LITTLE FURTHER BUT THE DELIVERY SYSTEM WOULD NOT CONTINUE TO ADVANCE. THE DELIVERY SYSTEM WAS STUCK ON THE GUIDE WIRE. ANOTHER SHEATH, HT STEELCORE GUIDE WIRE AND SENSOR WERE USED AND THE SENSOR WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT 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 13314848 ↗
• MalfunctionDec 3, 2021Break; Stretched; Break; Stretched

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925071 ↗
• MalfunctionDec 3, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING USE OF THE STEELCORE GUIDE WIRE, THERE WAS A BREAK IN THE COILS AND THE SPRINGS APPEAR TO HAVE OPENED [STRETCHED COILS]. ALTHOUGH IT WAS REPORTED THERE WAS EXTENDED TIME IN THE PROCEDURE THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925012 ↗
• MalfunctionNov 15, 2021Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT DURING USE OF THE STEELCORE GUIDE WIRE, THERE WAS A BREAK IN THE COILS AND THE SPRINGS APPEAR TO HAVE OPENED [STRETCHED COILS]. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS EXTENDED TIME IN THE PROCEDURE BUT NO EFFECT WAS REPORTED TO THE PATIENT. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE CORE OF THE WIRE WAS INTACT BUT THE COIL SEEMED PULLED IN A SECTION AND WASN'T VISIBLE ON ANGIOGRAPHY. THE COILS WERE ONLY STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12816797 ↗