HI-TORQUE BALANCE MIDDLEWEIGHT™ 1011880Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08717648144783), received between Dec 1, 2017 and Apr 9, 2025 — classified as 1 death, 13 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2025Break; Material Separation; Use of Device Problem; Break; Material Separation; Use of Device Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT IS 80% STENOSED. WHEN ATTEMPTING TO ROTATE THE HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE, THE GUIDE WIRE WOULD NOT ROTATE AND THERE WAS NO RESISTANCE FELT. WHEN WITHDRAWING THE GUIDE WIRE, THE CORE SEPARATED AND AN UNSPECIFIED BALLOON WAS USED TO COMPRESS THE DEVICE TOGETHER WITH THE GUIDING CATHETER TO SUCCESSFULLY REMOVE IT. AN UNSPECIFIED GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. 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 21807999 ↗
• MalfunctionMar 4, 2025Material Separation; Material Too Soft/Flexible; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDLY TORTUOUS, LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 80% STENOSED. DURING USE WITH THE 0.014 HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE, WHILE ROTATING THE GUIDE WIRE, THE SUPPORT FELT LIGHT AND DIFFERENT THAN EXPECTED. THE GUIDE WIRE WAS REMOVED AND IT WAS NOTED TO BE BROKEN IN TWO SEPARATE PIECES. THE SEPARATED PORTION WAS WITHDRAWN ALONG WITH THE GUIDING CATHETER WITH NO ISSUES. 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 21517263 ↗
• InjuryFeb 5, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED IN THE OBTUSE MARGINAL WHEN RESISTANCE WAS NOTED WITH A PREVIOUSLY IMPLANTED UNSPECIFIED STENT IN THE CIRCUMFLEX ARTERY (BIFURCATION). THE GUIDE WIRE BECAME STUCK WITH THE STENT AND SEPARATED APPROXIMATELY HALF A MILLIMETER (TIP). THE TIP WAS LEFT IN THE IMPLANTED STENT, ENDING THE PROCEDURE. THERE WAS NO PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21314469 ↗
• MalfunctionJan 27, 2025Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Break; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY, AFTER THE REPORT WAS FILED IT WAS NOTED THAT THE GUIDEWIRE BROKE, AND THE SPRING COIL UNSCREWED; HOWEVER, THE GUIDE WIRE REMAINED CONNECTED BY A SPRING COIL. ADDITIONAL FORCE WAS APPLIED WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE WITH GUIDING CATHETER AND BALLOON AS ONE UNIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21243933 ↗
• InjuryDec 12, 2024Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS ADVANCED TO THE C2 CURVE OF THE RCA BUT WAS UNABLE TO ADVANCE OR WITHDRAW DUE TO RESISTANCE WITH THE DEVICE ITSELF. A NON-ABBOTT GUIDE WIRE WAS THEN ADVANCED AND THE BMW ELITE WAS GOING TO BE WITHDRAWN BUT IT WAS NOTED THAT THE TIP OF THE BMW ELITE HAD SEPARATED AND WAS IN THE C2 CURVE OF THE ARTERY. THE REMAINING PORTION OF THE WIRE WAS WITHDRAWN AND A STENT WAS IMPLANTED TO EMBED THE SEPARATED PORTION AGAINST THE VESSEL WALL. ANGIOGRAPHY WAS PERFORMED AND SHOWED NO THROMBUS OR DISSECTION AND THERE WAS TIMI 3 FLOW. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20916317 ↗
• InjuryOct 14, 2024Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method

  USER FACILITY MEDSUN REPORT RECEIVED THAT STATES: "INTERVENTIONAL WIRE BROKE WITHIN CORONARY VESSEL. FRAGMENT REMAINS IN BODY." NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 20444986 ↗
• MalfunctionSep 19, 2024

  INTERVENTIONAL WIRE BROKE WITHIN CORONARY VESSEL. FRAGMENT REMAINS IN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20256638 ↗
• InjuryAug 21, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE BALANCE MIDDLEWEIGHT GUIDE WIRE WAS ATTEMPTED TO BE REMOVED AFTER THREE TURNS; HOWEVER COULD NOT BE REMOVED. THE GUIDE WIRE WAS ULTIMATELY REMOVED; HOWEVER, THE DISTAL TIP REMAINED IN THE PATIENT'S DISTAL LOWER LEFT PULMONARY ARTERY. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20010267 ↗
• MalfunctionApr 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE OF THE 014 HT BMW ELITE 190CM GUIDE WIRE, RUST WAS FOUND ON THE SPRING COIL AT THE TIP OF THE GUIDE WIRE (REPEATEDLY CONFIRMED NOT TO BE BLOOD), SO ANOTHER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126487 ↗
• InjuryOct 23, 2023Break; Difficult to Remove; Material Separation; Break; Difficult to Remove; Material Separation

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED, IT WAS REPORTED THAT THE HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE MET RESISTANCE DURING REMOVAL WITH GUIDE CATHETER. SNARING WAS ATTEMPTED; HOWEVER, WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED BY MEDIAN STERNOTOMY. LIMITED FORCE WAS APPLIED ONCE RESISTANCE WAS FELT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17990106 ↗
• MalfunctionMar 20, 2023Material Separation; Material Too Soft/Flexible; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT A PULMONARY ARTERY CATHETERIZATION PROCEDURE WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA). THE 014 HT BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE VWIRE (GW) WAS BEING ADVANCED WHEN THE GW CORE BROKE IN TWO PIECES INSIDE A PULMONARY ARTERY CATHETER. THE GW WAS REMOVED FROM THE PATIENT. THE PHYSICIAN REPORTED THE GW FELT WEAK. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT GW WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573086 ↗
• InjuryFeb 10, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED FIRST DIAGONAL ARTERY. THE 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS NOTED TO HAVE MET RESISTANCE WITH AN UNSPECIFIED GUIDEWIRE WHEN ATTEMPTING TO ADVANCE THROUGH THE UNSPECIFIED GUIDE CATHETER. IT WAS NOTED THREE UNSPECIFIED GUIDE WIRES WERE ALSO IN THE GUIDE CATHETER AT THE TIME. THE PROXIMAL SHAFT OF THE XIENCE SKYPOINT BECAME KINKED THEREFORE, THE PHYSICIAN DECIDED TO REMOVE EVERYTHING AS ONE UNIT AS HE THOUGHT IT WOULD BE SAFER. THEN HE ADVANCED ANOTHER GUIDE CATHETER AND WAS ABLE TO IMPLANT AND UNSPECIFIED STENT. A 014 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ATTEMPTED TO BE ADVANCE PAST THE IMPLANTED STENT; HOWEVER, THE TIP BECAME CAUGHT AT THE EDGE OF THE IMPLANTED STENT. THE PHYSICIAN DID NOT WANT TO RISK THE TIP FROM SEPARATING; THEREFORE, A MICRO CATHETER WAS ADVANCED TO KEEP THE STENT IN PLACE WHILE PULLING BACK THE GUIDE WIRE BACK AND WAS SUCCESSFULLY REMOVED. NO DAMAGE WAS NOTED ON THE GUIDE WIRE. 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 16354533 ↗
• InjuryJan 9, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE TRANSSEPTAL TO LEFT ATRIUM. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDEWIRE HAD NO RESISTANCE DURING ADVANCEMENT AND AFTER THE CASE, IT WAS NOTICED ON X-RAY THAT A PIECE OF THE GUIDEWIRE WAS STILL INSIDE THE HEART. THERE WAS RESISTANCE WHEN TRYING TO PULL PART OF THE GUIDEWIRE BACK INTO THE TRANSSEPTAL NEEDLE, HOWEVER, NO FORCE WAS APPLIED. THE SHEATH WAS ADVANCED OVER THE ENTIRE SYSTEM INTO THE LEFT ATRIUM AND WITHDREW THE DILATOR NEEDLE AND GUIDEWIRE AS A UNIT. FLUOROSCOPY WAS NOT USED AND DID NOT VISUALIZE ANYTHING ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). IT WAS PROBABLY ALL IN THE SHEATH AND WHEN THE CIRCULAR MAPPING CATHETER WAS REMOVED IT CAME OUT WITH IT BUT OBVIOUSLY COULD HAVE ACCIDENTALLY BEEN PUSHED INTO THE LEFT ATRIUM DURING MAPPING. THE SEPARATED GUIDEWIRE WAS REMOVED SUCCESSFULLY USING A SNARE DEVICE. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121372 ↗
• MalfunctionNov 23, 2022Product Quality Problem; Material Separation; Product Quality Problem; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 014 HT BMW ELITE GUIDE WIRE (GW) WAS USED FOR THE PROCEDURE WITHOUT ISSUE. DURING REMOVAL FROM THE ANATOMY, THE TIP OF THE GUIDE WIRE FELT AS IF IT ROTATED ABNORMALLY AND BECAME SEPARATED IN TWO PIECES WITH THE SEPARATED SEGMENT REMAINING IN THE Y VALVE. THE SEPARATED SEGMENT WAS SIMPLY REMOVED WITHOUT A SNARE AND NO GUIDE WIRE PIECES WERE LEFT IN THE PATIENT. 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 15859402 ↗
• InjuryNov 15, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE OBTUSE MARGINAL (OM) ARTERY. THE 014 HT BALANCED MIDDLE-WEIGHT ELITE GUIDE WIRE (GW) WAS USED WITHOUT ISSUE; HOWEVER, UPON REMOVAL FROM THE ANATOMY, RESISTANCE WAS MET WITH AN UNKNOWN SOURCE AND THE TIP OF THE GW SEPARATED IN THE PATIENT ANATOMY. ANOTHER STENT WAS USED TO PIN THE SEPARATED TIP OF THE GUIDE WIRE TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15801184 ↗
• DeathJul 6, 2022Difficult 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 PATIENT'S CLINICAL PRESENTATION WAS UNSTABLE ANGINA AND THE PROCEDURE WAS TO USE THE HI-TORQUE (HT) BALANCE MIDDLE WEIGHT (BMW) ELITE GUIDE WIRE FOR DIAGONAL BRANCH PROTECTION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN UNSPECIFIED STENT WAS DEPLOYED IN THE LAD AND WHEN THE PROTECTIVE HT BMW ELITE GUIDE WIRE WAS WITHDRAWN, THE GUIDE WIRE SEPARATED AND REMAINED IN THE VESSEL SINCE IT COULD NOT BE RETRIEVED. THERE WAS RESISTANCE WITH THE DEPLOYED STENT DURING WITHDRAWAL AND FORCE WAS APPLIED. ATTEMPTS WERE MADE TO REMOVE THE SEPARATED PORTION WITH OTHER GUIDE WIRES, BUT WERE UNSUCCESSFUL. THE SEPARATED TIP WAS PARTIALLY EMBEDDED BETWEEN THE STENT AND VESSEL WALL. ANGIOGRAPHY WAS PERFORMED DURING THE PROCEDURE AND NO THROMBUS WAS FOUND. THE PATIENT DIED OF THROMBUS A FEW DAYS LATER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Thrombosis/Thrombus

  MAUDE report 14938966 ↗
• InjuryFeb 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE (GW) WAS ADVANCED INTO THE SIDE SEPTAL BRANCH. THE LESION WAS BALLOONED AND STENTED. DURING REMOVAL OF THE GW, IT WAS DETERMINED THAT IT WAS ADVANCED TOO FAR DOWN THE LAD, WHICH CAUSED DIFFICULTY REMOVING THE GW FROM THE ANATOMY. ADDITIONALLY, IT WAS BELIEVED THAT THE PATIENT WAS HAVING VASOSPASMS, CAUSING THE GW TO BECOME STUCK; THEREFORE, THE PATIENT WAS GIVEN VASODILATOR MEDICATION TO DILATE THE BLOOD VESSELS IN ORDER TO REMOVE THE GW WITHOUT FURTHER ISSUE. THE WIRE WAS SUCCESSFULLY REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vasoconstriction

  MAUDE report 13596154 ↗
• MalfunctionApr 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, 60% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. A BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS USED WITHOUT ISSUES ON (B)(6) 2021, BUT AFTERWARDS, THE EXPIRATION DATE WAS NOTED TO BE 10/31/2019. 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 11649859 ↗
• MalfunctionNov 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE BALANCE MIDDLE WEIGHT (BMW) GUIDEWIRE ADVANCED WITHIN THE GUIDE CATHETER WITHOUT ISSUE. THE GUIDE CATHETER HOWEVER, WAS UNABLE TO CROSS THE RIGHT CORONARY ARTERY LESION AND KEPT DISLODGING OUT IF PLACE. ALL WAS REMOVED FROM THE PATIENT. ONCE OUTSIDE THE ANATOMY, THE BMW PROXIMAL/MEDIAL SECTION WAS OBSERVED SEPARATED. THERE WAS NO UNUSUAL RESISTANCE NOTED WITH THE BMW. THERE WAS NO ADVERSE PATENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS RE-WIRED WITH ANOTHER UNSPECIFIED DEVICE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779717 ↗
• MalfunctionNov 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE BALANCE MIDDLE WEIGHT (BMW) GUIDEWIRE PROXIMAL/MEDIAL SECTION SEPARATED WHILE CURVING THE TIP. THERE WAS NO UNUSUAL RESISTANCE, OR ISSUE HANDLING THE DEVICE. INSERTION WAS NOT ATTEMPTED, AND THE DEVICE WAS SET ASIDE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10779606 ↗
• MalfunctionDec 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS BEING INTRODUCED INTO AN UNSPECIFIED GUIDING CATHETER WHEN THE GUIDE WIRE CORE SEPARATED. THE SEPARATED GUIDE WIRE WAS REMOVED ALONG WITH THE GUIDING CATHETER. A NON-ABBOTT GUIDE WIRE WAS 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 Consequences Or Impact To Patient

  MAUDE report 9495263 ↗
• MalfunctionDec 2, 2019Break; Stretched; Break; Stretched

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: THE TIP COILS OF THE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WERE ACTUALLY STRETCHED AND NOT SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9396078 ↗
• InjuryMar 26, 2019Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS SUBCLAVIAN ARTERY. INTRAVASCULAR ULTRASOUND (IVUS) WAS BEING PERFORMED WITH A 014 HI-TORQUE BALANCE MIDDLE WEIGHT GUIDE WIRE (GW). AS THE GW WAS ADVANCED RESISTANCE WAS FELT WITH THE IVUS CATHETER WHEN IT WAS OBSERVED THAT THE GW CORE BROKE IN TWO PIECES. THE SEPARATED PORTION WAS SUCCESSFULLY SNARED. NOTHING REMAINED IN THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8454005 ↗
• MalfunctionAug 3, 2018Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS HEAVILY CALCIFIED. THE HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE WAS ADVANCED WITH RESISTANCE BUT SUCCESSFULLY MADE IT TO THE LESION. DURING REMOVAL, THE GUIDE WIRE MET RESISTANCE WITH THE NON-ABBOTT BALLOON. THE GUIDE WIRE AND BALLOON WERE REMOVED AS A SINGLE UNIT. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE HAD SOME KIND OF UNUSUAL KNOB AT THE TIP WHICH MAY HAVE CAUSED THE ISSUE. THERE WERE NO REPORTED 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 7749106 ↗
• InjuryJul 31, 2018Improper or Incorrect Procedure or Method; Difficult to Advance; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. RESISTANCE MET WITH THE ANATOMY WHEN ADVANCING A 0.014 BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE. AFTER MANIPULATION AGAINST SIGNIFICANT RESISTANCE, THE BMW CROSSED INTO THE PROXIMAL DIAGONAL BRANCH. A NON-ABBOTT STENT WAS DEPLOYED THROUGH THE PROXIMAL LAD. NEXT, A SECOND 0.014 BMW GUIDE WIRE CROSSED THROUGH THE PREVIOUSLY IMPLANTED STENT AND INTO THE PROXIMAL TO MID LAD. AFTER CROSSING THE STENT, THERE WAS SIGNIFICANT RESISTANCE TO THE BMW GUIDE WIRE, BUT WITH CAREFUL MANIPULATION THE BMW WAS ABLE TO ADVANCE FURTHER WHEN THE BMW APPEARED TO PREFERENTIALLY ENTER INTO A SEPTAL PERFORATOR. ANGIOPLASTY WAS THEN PERFORMED THROUGHOUT THE LAD. THERE WAS INTRAVASCULAR ULTRASOUND (IVUS) OF THE LEFT MAIN AND THE LAD. NEXT, IT APPEARED THAT THE BMW MAY HAVE RESULTED IN A SUBINTIMAL PASSAGE SO AN IVUS CATHETER WAS INSERTED. THE IVUS WAS ADVANCED AND THERE WAS DIFFICULTY CROSSING, SO THE BMW WAS REMOVED. AFTER IVUS, THE SECOND BMW GUIDE WIRE WAS THEN RE-INSERTED AND ADVANCED WITH SIGNIFICANT RESISTANCE DUE TO THE ANATOMY, CROSSING MULTIPLE SEPTAL PERFORATORS. FURTHER ANGIOPLASTY WAS PE

  Patient problems: Perforation

  MAUDE report 7735580 ↗