HI-TORQUE BALANCE MIDDLEWEIGHT 1001780-HCRecalls & reported problems

Summary

The FDA's MAUDE database contains 156 adverse event reports that list this exact device (DI 08717648025969), received between Aug 29, 2016 and Sep 24, 2026 — classified as 1 death, 67 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Material Separation” (75 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 156 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Break; Entrapment of Device

  It was reported that the procedure was to treat a heavily calcified, heavily tortuous right coronary artery lesion with 99% stenosis. A Hi-Torque 014 Balance Middleweight (BMW) guide wire was advanced for use. During removal through the guide catheter, resistance was noted and the guide wire core broke, but remained in one piece. A snare was used to retrieve the guide wire. A new BMW guide wire was used to continue 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 50886310 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857738 ↗
• InjurySep 18, 2026Material Separation

  It was reported that the procedure was to treat a heavily calcified, mildly tortuous 1st diagonal artery lesion with chronic total occlusion. A 014 Hi-Torque BMW guide wire was prepared advanced without issue. Two non-Abbott stents were implanted without issue. However, during removal, the guide wire tip separated. A snare was used to retrieve the wire tip, but the tip was lost in the aorta. A vascular retriever was then used to successfully retrieve the wire tip and 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 50821545 ↗
• InjurySep 15, 2026Difficult to Remove; Material Separation; Stretched

  It was reported the procedure was to treat a lesion in the Right Coronary Artery (RCA). The BMW Hydro guide wire was used in the procedure. After successfully stenting the lesions, the guide wire was retracted with some resistance. Outside of the anatomy it was noted the guide wire was frayed and the distal tip was missing. Fluoro images confirmed a small portion of the distal tip of the guide wire was wedged under the stent struts. No additional information was provided.

  Patient problems: Foreign Body In Patient

  MAUDE report 50772039 ↗
• MalfunctionSep 2, 2026Difficult to Remove; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572288 ↗
• InjuryJun 10, 2026Entrapment of Device; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SIDE BRANCH OF THE LEFT MAIN CORONARY ARTERY. THE SEPARATION WAS AT THE CORE OF THE GUIDE WIRE (GW) WHICH OCCURRED DUE TO THE GW BECAME JAILED WITH THE UNSPECIFIED STENT THAT WAS IMPLANTED IN THE PROCEDURE.NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25462732 ↗
• MalfunctionMar 2, 2026Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MODERATELY TORTUOUS FIRST OBTUSE MARGINAL LESION. A HI-TORQUE 014 BMW HYDRO GUIDE WIRE WAS USED; HOWEVER, THE GUIDE WIRE COILS UNRAVELED INSIDE THE CORONARY ARTERY, BUT THE CORE REMAINED INTACT. AN ADDITIONAL BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA 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 24490068 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT PRIOR TO USE, THE TIP OF THE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE WAS NOTED TO BE BROKEN. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER BMW GUIDE WIRE WAS USED TO COMPETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239988 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. AFTER THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS REMOVED FROM THE DISPENSER HOOP, IT WAS NOTED THAT THE WIRE WAS SEPARATED IN 2 PIECES. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907500 ↗
• InjuryNov 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BMW HYDRO GUIDE WIRE WAS USED DURING THE PROCEDURE HOWEVER AFTER THE GUIDE WIRE WAS REMOVED, IT WAS NOTED THE TIP OF THE GUIDE WIRE UNRAVELED AND BROKE OFF INSIDE THE PATIENT. A STENT WAS DEPLOYED OVER THE SEPARATED PORTION EMBEDDING IT INTO THE VESSEL. 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 23660504 ↗
• InjuryNov 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT RIGHT SUBCLAVIAN ARTERY WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. THE HI-TORQUE 014 BMW HYDRO 3CM GUIDE WIRE (GW) WAS ADVANCE TO THE RIGHT BASILIC VEIN THE RIGHT SUBCLAVIAN VEIN WHEN THE GW SEPARATED IN 2 PIECES. PART OF THE GW WAS ABLE TO BE REMOVED; HOWEVER, PART OF THE GW REMAINED IN THE PATIENT. THEREFORE, A MICRO SNARE WAS USED TO REMOVE THE SEPARATED PORTION OF THE GW THAT REMAINED IN THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467156 ↗
• InjuryOct 30, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: WIRE FRAYING RESULTING IN BROKEN TIP. HYPERTENSION, CORONARY ARTERY DISEASE, SOCRATIC ARTHRITIS, PACEMAKER, AND QUESTIONABLE ARTIAL FIBRILLATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PROCEDURE PERFORMED WAS TO TREAT A LEFT CIRCUMFLEX CORONARY ARTERY (CX). DURING ADVANCEMENT OF THE 3CM HI-TORQUE (HT) 014 BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE, DIFFICULTY WAS NOTED DUE TO THE ANATOMY, FROM THE LEFT ANTERIOR DESCENDING CORONARY ARTERY TO THE CX. AFTER REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE HT BMW GUIDE WIRE SEPARATED. THE SEPARATED PORTION WAS CRUSHED AGAINST THE VESSEL WALL WITH A DRUG-ELUTING STENT. AN UNSPECIFIED WHISPER GUIDE WIRE WAS USED WITH AN UNSPECIFIED STENT TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT DIED; HOWEVER, IN THE PHYSICIAN'S OPINION, THE BMW GUIDE WIRE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23429651 ↗
• MalfunctionSep 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDEWIRE WAS ADVANCED AND A XIENCE PRO S STENT DELIVERY SYSTEM (SDS) WAS ALSO ADVANCED WITHOUT RESISTANCE; HOWEVER, THE STENT WAS ATTEMPTED TO BE DEPLOYED BUT TBE WIRE GOT STUCK ON THE STENT AND HAD TO BE REMOVED AS A SINGLE UNIT. ANOTHER HT BMW HYDRO AND XIENCE PRO S WERE USED AND COMPLETED 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 22955858 ↗
• MalfunctionJul 10, 2025Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX/MARGINAL CORONARY ARTERIES. THE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE WAS OPENED AND FLUSHED AND SHAPED. ONCE THE WIRE WAS ADVANCED OUT OF THE GUIDING CATHETER INTO THE ANATOMY, IT WAS NOTED THAT THE TIP WAS UNRAVELED AND STRETCHED, BUT REMAINED IN ONE PIECE (NOT BROKEN OR SEPARATED). THE DEVICE WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE CORE, SHAPING RIBBON AND COILS SEPARATED. THE CORE AND SHAPING RIBBON WERE SEPARATED 1MM DISTAL TO THE CENTER SOLDER. THE DISTAL COILS WERE SEPARATED, UNRAVELED AND STRETCHED FOR A LENGTH OF 32CM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470989 ↗
• MalfunctionJul 1, 2025Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN AN UNKNOWN VESSEL. DURING THE USE WITH THE UNIVERSAL BMW II GUIDE WIRE AN OCT CATHETER COULD NOT PASS OVER THE GUIDE WIRE DUE TO AN OBSTACLE ON THE GUIDE WIRE, AND BECOME STUCK. THE DEVICES WERE REMOVED AS A SINGLE UNIT AND THE GUIDE WIRE WAS REPLACED. A NEW GUIDE WIRE WAS USED WITH THE SAME OCT CATHETER SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374071 ↗
• InjuryJun 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER COMPLETION OF THE PROCEDURE IT WAS NOTED THE BMW HYDRO GUIDE WIRE HAD SEPARATED INSIDE THE PATIENT. THE SEPARATED PORTION WAS REMOVED WITH OTHER DEVICES. 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 22329473 ↗
• MalfunctionMay 19, 2025Difficult to Remove; Difficult to Remove

  MEDSUN MANDATORY AND VOLUNTARY REPORT FORM # (B)(4) RECEIVED, REPORTING: DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS IN CATH LAB FOR INFERIOR WALL STEMI [ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION] AND HAD 2 STENTS PLACED IN RCA [RIGHT CORONARY ARTERY]. THE IVUS [INTRAVASCULAR ULTRASOUND] WAS USED AFTERWARDS TO ENSURE THE STENTS WERE PROPERLY PLACED AND DEPLOYED IN THE CORONARY ARTERY. WHEN IVUS IMAGING WAS DONE THE CATHETER COULD NOT BE REMOVED WITHOUT ALSO REMOVING THE GUIDEWIRE AT THE SAME TIME. IVUS CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER, AS A SINGLE UNIT. IT APPEARS THAT IVUS CATHETER GOT STUCK ON THE WIRE. NO HARM TO PATIENT BUT COULD HAVE POTENTIALLY CAUSED HARD IF A GUIDEWIRE WAS STILL NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044065 ↗
• MalfunctionApr 21, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 80% STENOSED. AN UNSPECIFIED BALLOON DILATATION CATHETER WAS ATTEMPTING TO ADVANCE OVER THE HT BALANCE MIDDLEWEIGHT HYDRO GUIDE; HOWEVER, THE WIRE WAS STICKING WITH THE BALLOON. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON INDEPENDENTLY; HOWEVER, WAS UNSUCCESSFUL. BOTH DEVICES WERE REMOVED FROM THE ANATOMY TOGETHER. A WHISPER GUIDE WIRE 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 21876498 ↗
• MalfunctionMar 24, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN USING THE BMW (BALANCE MIDDLEWEIGHT) GUIDEWIRE WITH THE DRAGONFLY OPSTAR OCT (OPTICAL COHERENCE TOMOGRAPHY) CATHETER AND / OR A NON-ABBOTT IVUS (INTRAVASCULAR ULTRASOUND) CATHETER, IT WAS NOTED THAT UPON REMOVING THE OCT/IVUS CATHETER OUT OF THE PATIENT AFTER TAKING THE IMAGING PULLBACK, THE OCT/IVUS CATHETER STICKS ONTO THE BMW WIRE AND THUS, ALSO PULLS THE WIRE OUT OF THE PATIENT WITH THE CATHETER. SUBSEQUENTLY WHEN USING A NON-ABBOTT GUIDEWIRE, THE OCT/IVUS CATHETER DOES NOT STICK TO THE NON-ABBOTT GUIDEWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21681987 ↗
• MalfunctionMar 21, 2025Break; Stretched; Difficult to Advance; Break; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY TO THE RIGHT CORONARY ARTERY (RCA). THE HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS ADVANCED TO THE RCA AND AN UNSPECIFIED TREK BALLOON WAS USED TO PRE DILATATE SUCCESSFULLY. THE AN UNSPECIFIED XIENCE STENT TRACK OVER THE GUIDE WITHOUT ISSUE THE STENT WAS DEPLOYED SUCCESSFULLY. THE GUIDE WIRE WAS THEN ADVANCED TO THE LAD; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY AND ONCE AT THE LESION UNDER FLUOROSCOPY THE TIP COILS WERE NOTED TO BE STRETCHED. THE CORE OF THE GUIDE WIRE SEPARATED, BUT THE GUIDE WIRE REMAINED IN PIECE. THE GUIDE WIRE WAS REMOVED WITHOUT ISSUE AND ANOTHER BMW WAS USED TO SUCCESSFULLY CONTINUE 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 21667715 ↗
• InjuryMar 7, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A STENOSED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. THE BMW HYDRO GUIDE WIRE WAS ADVANCED TO THE TARGET LESION FOLLOWED BY BALLOON DILATATION TO PREP THE LESION. AN ATTEMPT WAS MADE TO RECROSS THE GUIDE WIRE HOWEVER THE DISTAL TIP WAS TRAPPED IN A SMALL BRANCH OF THE LCX. AN SECOND ATTEMPT WAS MADE TO PULL THE GUIDE WIRE HOWEVER IT DID NOT MOVE AT ALL AND IT WAS NOTED THE COILS WERE UNRAVELED. A BALLOON CATHETER WAS ADVANCED AND INFLATED AT THE TIP OF THE GUIDING CATHETER TO ENTRAP THE GUIDE WIRE BETWEEN THE BALLOON AND INNER WALL OF THE GUIDING CATHETER. THE GUIDE WIRE WAS PULLED GENTLY AND WAS ABLE TO BE REMOVED FROM THE PATIENT. 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 21546314 ↗
• InjuryDec 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OR REMOVAL, BUT THE TIP OF THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE SEPARATED IN THE RCA AND WAS RETRIEVED VIA SURGICAL THORACOTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20964267 ↗
• InjuryDec 16, 2024Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA). THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS USED IN THE PROCEDURE AND WHEN IT WAS PASSED THROUGH THE MIDDLE SEGMENT OF THE RCA, THE GUIDE WIRE BECAME BROKEN BUT HELD TOGETHER BY STRETCHED COILS. THE WIRE WAS CAUGHT WITH THE CALCIFIED ANATOMY DURING ADVANCEMENT AND REMOVAL. THE GUIDE WIRE WAS WITHDRAWN INDEPENDENTLY AND TYPE A DISSECTION SHADOWS WERE SEEN IN THE PROXIMAL AND MIDDLE SEGMENTS OF THE RCA. ANOTHER BMW GUIDE WIRE WAS USED TO PASS THROUGH THE DISTAL SEGMENT OF THE RCA AND COMPLETE THE PROCEDURE. THERE WAS NO TREATMENT FOR THE DISSECTION AND THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 20947834 ↗
• InjuryNov 27, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE .014 HI-TORQUE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE WITH ANATOMY. THE GUIDE WIRE WAS INSERTED INTO THE FALSE CAVITY. THEREFORE, THE GUIDE WIRE WAS WITHDRAWN WITH NOTED RESISTANCE WITH ANATOMY. DURING REMOVAL OF THE GUIDEWIRE, ANGIOGRAPHY CONFIRMED SEPARATION OF ABOUT 1.0CM OF THE GUIDEWIRE TIP. THE TIP WAS EMBEDDED INTO THE VESSEL WALL BY IMPLANTING ANOTHER STENT. A NEW HI-TORQUE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 20799247 ↗
• InjuryNov 1, 2024Difficult 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 PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS ADVANCED AND A NON-ABBOT STENT WAS IMPLANTED. HOWEVER, THE DISTAL TIP OF THE GUIDE WIRE GOT STUCK WITH THE IMPLANTED STENT AND THE GUIDE WIRE COULD NOT BE REMOVED. THE PHYSICIAN INTENTIONALLY FRACTURED ABOUT 20MM FROM THE PROXIMAL END OF THE DEVICE AND THE REST OF THE GUIDE WAS LEFT IN THE PATIENT WHILE AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHEREIN SURGERY WAS PERFORMED TO REMOVE THE REST OF THE DEVICE. NOTHING REMAINED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20591547 ↗