HI-TORQUE BALANCE MIDDLEWEIGHT 1001780J-HCRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 08717648025983), received between Sep 8, 2016 and Aug 3, 2026 — classified as 30 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (37 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 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123715 ↗
• MalfunctionAug 3, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50123714 ↗
• MalfunctionNov 7, 2025Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE DISTAL THIRD OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDEWIRE WAS ADVANCED AND THE DRAGONFLY OPSTAR IMAGING CATHETER WAS USED FOR IMAGING WITHOUT ISSUE. A STENT WAS IMPLANTED AND THE IMAGING CATHETER WAS ADVANCED FOR POST-RUN EXECUTION WHEN AN ERROR MESSAGE "CONNECTION FAILURE 395 - THE IMAGING CATHETER COULD NOT BE CONNECTED. PLEASE UNLOAD AND TRY AGAIN (CAL-002)". THE HT BMW GUIDEWIRE WAS BEING REMOVED WHEN RESISTANCE WITH THE CATHETER WAS NOTED SINCE SLIDING WAS NOT EASY BUT REMOVED INDEPENDENTLY. A MINOR DAMAGE [BENT TIP] WAS NOTED ON THE RADIOPAQUE TIP OF THE GUIDEWIRE. ALSO UPON INSPECTION OF THE DRAGONFLLY OPSTAR, A LIGHT SIGNAL AT THE SECOND MARKER OF THE LENS WAS OBSERVED AND POSSIBLE DAMAGED LENS. THE PROCEDURE WAS COMPLETED AT THIS POINT WITHOUT THE FINAL POST-PROCEDURE IMAGING. 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 23500962 ↗
• MalfunctionNov 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL-MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY. WHEN THE 2.5X38MM XIENCE SIERRA STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE DISPENSER HOOP, THE STENT WAS NOTED TO BE CRUSHED. THE SDS WAS NOT USED IN THE PROCEDURE AND ANOTHER XIENCE SIERRA SDS WAS USED TO CONTINUE THE PROCEDURE. IN THE SAME PROCEDURE, THE HI-TORQUE 014 BMW HYDRO GUIDE WIRE (GW) WAS BEING USED; HOWEVER, WHEN ATTEMPTING TO WITHDRAW THE GW, RESISTANCE (FRICTION) WAS NOTED WITH VARIOUS UNSPECIFIED BALLOONS AND STENTS. RESISTANCE WAS FELT MORE TOWARD THE END OF 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 23494357 ↗
• MalfunctionNov 5, 2025Break; Product Quality Problem; Break; Product Quality Problem

  IT WAS REPORTED THAT DURING PREPARATION OF THE BMW HYDRO GUIDE WIRE, IT WAS NOTED THE EXTREMITY WAS TORN AND SEEMED DEFECTIVE. ANOTHER GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS DID NOT CONFIRM THE REPORTED TORN EXTREMITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475448 ↗
• MalfunctionSep 4, 2025Difficult 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 DURING ADVANCEMENT OF THE DRAGONFLY IMAGING CATHETER ONTO THE .014 HI-TORQUE BALANCE MIDDLE WEIGHT HYDRO GUIDE WIRE, THE GUIDE WIRE DEVELOPED KINKS (BENDS) ALONG THE "BODY" [CORE ] DUE TO RESISTANCE DURING ADVANCEMENT WITH THE IMAGING CATHETER. RESISTANCE WAS ALSO MET BETWEEN THE IMAGING CATHETER AND BALANCE MIDDLE WEIGHT GUIDE WIRE DURING REMOVAL; HENCE, THE GUIDEWIRE AND IMAGING CATHETER WERE REMOVED TOGETHER AS A SINGLE UNIT. THE SAME IMAGING CATHETER WAS USED WITH A DIFFERENT SIZE AND UNSPECIFIED GUIDEWIRE TO 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 22968188 ↗
• MalfunctionMay 8, 2025Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE DISTAL OPAQUE PORTION BECAME FRAYED [BROKEN] WITHOUT EXPLANATION. THERE WERE NO REPORTED 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 21990239 ↗
• MalfunctionMar 31, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 70% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER CONNECTING THE DRAGONFLY CATHETER, A GRINDING SOUND WAS HEARD AND AN ERROR MESSAGE 1701 (THERE IS A PROBLEM CONNECTING THE CATHETER) APPEARED. THE CATHETER WAS DISCONNECTED AND RECONNECTED WITHOUT PROBLEMS AND IMAGING WAS PERFORMED. THE CATHETER GOT STUCK ON A HI-TORQUE 014 BMW GUIDE WIRE AND THEY HAD TO BE REMOVED TOGETHER. ANOTHER BMW GUIDE WIRE FROM THE SAME SERIES WAS USED FOR THE PERCUTANEOUS CORONARY INTERVENTION AND THE FINAL OCT WAS PERFORMED. AFTER THIS PULLBACK, THE CATHETER ALSO GOT STUCK ON THE WIRE AND AGAIN THEY HAD TO BE REMOVED FROM THE CORONARY ARTERY TOGETHER. 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 21733980 ↗
• MalfunctionMar 31, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 70% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER CONNECTING THE DRAGONFLY CATHETER, A GRINDING SOUND WAS HEARD AND AN ERROR MESSAGE 1701 (THERE IS A PROBLEM CONNECTING THE CATHETER) APPEARED. THE CATHETER WAS DISCONNECTED AND RECONNECTED WITHOUT PROBLEMS AND IMAGING WAS PERFORMED. THE CATHETER GOT STUCK ON A HI-TORQUE 014 BMW GUIDE WIRE AND THEY HAD TO BE REMOVED TOGETHER. ANOTHER BMW GUIDE WIRE FROM THE SAME SERIES WAS USED FOR THE PERCUTANEOUS CORONARY INTERVENTION AND THE FINAL OCT WAS PERFORMED. AFTER THIS PULLBACK, THE CATHETER ALSO GOT STUCK ON THE WIRE AND AGAIN THEY HAD TO BE REMOVED FROM THE CORONARY ARTERY TOGETHER. 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 21733799 ↗
• InjuryMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE ANTERIOR DESCENDING ARTERY. WHEN A 3CM .014 HI-TORQUE BMW GUIDEWIRE (GW) WAS ADVANCED IN THE ANATOMY THE GW WAS NOTED TO SEPARATE WITH PART OF THE WIRE INSIDE THE 5F GUIDING CATHETER AND THE OTHER PART IN THE VESSEL. THEREFORE, THE SEPARATED WIRE WAS RETRIEVED WITH A CORONARY BALLOON, AND THE GW WAS REPLACED WITH A SAME SIZED .014 HI-TORQUE BMW GW, BUT THE SAME EXACT ISSUE OCCURRED. THE PHYSICIAN DECIDED TO REPLACE THE BATCH OF BMW GWS WITH A NEW BATCH OF THE WHISPER MS GW, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATENT SEQUELA NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697726 ↗
• InjuryMar 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE ANTERIOR DESCENDING ARTERY. WHEN A 3CM .014 HI-TORQUE BMW GUIDEWIRE (GW) WAS ADVANCED IN THE ANATOMY THE GW WAS NOTED TO SEPARATE WITH PART OF THE WIRE INSIDE THE 5F GUIDING CATHETER AND THE OTHER PART IN THE VESSEL. THEREFORE, THE SEPARATED WIRE WAS RETRIEVED WITH A CORONARY BALLOON, AND THE GW WAS REPLACED WITH A SAME SIZED .014 HI-TORQUE BMW GW, BUT THE SAME EXACT ISSUE OCCURRED. THE PHYSICIAN DECIDED TO REPLACE THE BATCH OF BMW GWS WITH A NEW BATCH OF THE WHISPER MS GW, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATENT SEQUELA NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697692 ↗
• MalfunctionFeb 20, 2025Break; Material Separation; Stretched; Difficult to Advance; Break; Material Separation; Stretched; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORTS THE DEVICE WAS RETURNED AND THE TIP WAS SEPARATED. THE TIP SEPARATION WAS THE DAMAGE INITIALLY REPORTED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426794 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT WHEN REMOVING THE BMW GUIDE WIRE FROM THE PACKAGE, IT WAS NOTED THE GUIDE WIRE WAS BROKEN [UNRAVELED] AND COULD NOT BE USED. 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 21294085 ↗
• MalfunctionNov 27, 2024Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT WHEN THE BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS REMOVED FROM THE PROTECTIVE COVER, A BEND IN THE BODY OF THE WIRE WAS NOTED. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER BMW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A SEPARATION AT THE DISTAL SOLDER TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801520 ↗
• MalfunctionNov 1, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN .014 HI-TORQUE BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE WAS PLACED; HOWEVER, INFLATING THE 3.5X23MM XIENCE ALPINE STENT TO 16 ATMOSPHERES THE BALLOON OF THE DELIVERY SYSTEM BECAME STUCK WITH THE GUIDE. THEREFORE, THE DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED TOGETHER. 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 20587161 ↗
• InjurySep 16, 2024Material Separation; Difficult to Advance; Material Deformation; Material Separation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, ANGIOPLASTY WAS TO BE PERFORMED ON THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 014 HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WAS ADVANCED TO CAPTURE A MIGRATED UNSPECIFIED STENT. RESISTANCE WAS NOTED DUE TO THE ANATOMY AND SEVERE ANGULATION OCCURRED. THE GUIDEWIRE BECAME DAMAGED AND REMOVED FROM THE PATIENT. THE MIGRATED STENT WAS NOT RETRIEVED AND STILL REMAINED IN THE PATIENT. ON (B)(6) 2024, THE PATIENT RETURNED FOR AN ULTRASOUND (ARTERIAL DOPPLER) OF THE LEFT UPPER LIMB TO CHECK ULNAR PATENCY AND THE MIGRATED STENT. HOWEVER, THE DISTAL TIP OF THE GUIDEWIRE WAS OBSERVED TRAVELING TO THE UPPER THIRD OF THE HUMERAL ARTERY WITHOUT HEMODYNAMIC CONSEQUENCES. ON (B)(6) 2024, THE PATIENT UNDERWENT AN INTERVENTION PROCEDURE. AN ABLATION WAS PERFORMED TO ATTEMPT CAPTURING THE DETACHED GUIDEWIRE TIP RADIALLY. HOWEVER, THIS WAS UNSUCCESSFUL. ANOTHER INTERVENTION PROCEDURE IS SCHEDULED FOR A LATER DATE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20228746 ↗
• InjuryJul 10, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE BALANCE MIDDLEWEIGHT (BMW) GUIDEWIRE SEPARATED INSIDE THE CORONARY ARTERY. THE SEPARATED PORTION OF THE GUIDEWIRE WAS RETRIEVED WITH THE HELP OF A BALLOON CATHETER. 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 19713652 ↗
• MalfunctionMar 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE GUIDE WIRE WAS NOTED TO HAVE UNRAVELED WITH THE COILS UNWOUND BUT REMAINS IN ONE PIECE. ANOTHER BMW 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 18991857 ↗
• InjuryMar 11, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE IN THE DIAGONAL CORONARY ARTERY WITH MEDIUM CALCIFICATION AND NO TORTUOSITY, AN UNSPECIFIED STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, FOLLOWED BY POST-DILATION. NOTING RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND THE GUIDING CATHETER, THE 190CM HT TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE (GW) WAS SWITCHED WITH AN UNSPECIFIED GW BETWEEN THE DIAGONAL CORONARY ARTERY AND THE LAD CORONARY ARTERY IN ORDER TO OPEN THE STENT STRUTS TOWARDS THE DIAGONAL ARTERY. UPON WITHDRAWAL OF THE GW, RESISTANCE WAS FELT WITH THE DIAGONAL ARTERY AND THE STENT. THE GW TIP SEPARATED. UNSPECIFIED ATTEMPTS WERE MADE TO RETRIEVE THE TIP; HOWEVER, RETRIEVAL WAS UNSUCCESSFUL AND THE SEPARATED SEGMENT REMAINS BETWEEN THE IMPLANTED STENT AND THE LAD WALL. THE PROCEDURE WAS PROLONGED, WITH THE PATIENT RECEIVING INCREASED DOSES OF X-RAY AND IODINATED CONTRAST MATERIAL. THE HOSPITALIZATION WAS PROLONGED, AS ADDITIONAL MONITORING WAS REQUIRED DUE TO THE THROMBOEMBOLIC RISK. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18879782 ↗
• MalfunctionJan 27, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. FOUR HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRES HAD RESISTANCE DURING ADVANCEMENT AND GOT STUCK WITH AN UNSPECIFIED NUMBER OF BALLOON DEVICES. THE GUIDE WIRES AND BALLOONS STUCK WERE REMOVED FROM THE ANATOMY. ADDITIONAL GUIDE WIRES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED 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 18592768 ↗
• InjuryJan 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH 90-99% STENOSIS. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) HYDRO GUIDE WIRE HAD NO RESISTANCE DURING ADVANCEMENT. PRE-DILATATION WAS PERFORMED AND A STENT WAS IMPLANTED. HOWEVER, THE FLOPPY PART [TIP] SEPARATED EVEN THOUGH THERE WAS NO RESISTANCE DURING REMOVAL. THE SEPARATED PORTION REMAINED IN THE ANATOMY WITH A SECOND STENT BEING IMPLANTED TO SECURE THE SEPARATED PIECE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18465465 ↗
• InjuryAug 9, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION. THE HI-TORQUE BALANCE MIDDLEWEIGHT HYDRO 014 GUIDEWIRE WAS ATTEMPTED TO BE ADVANCED; HOWEVER, IT WAS NOTED SEPARATED; THEREFORE, THE DEVICE WAS RETRIEVED. ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA 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 17491210 ↗
• InjuryJun 20, 2023Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN AN UNSPECIFIED ARTERY. AFTER PUNCTURE, THERE WAS UNSUCCESSFUL RADIAL ACCESS WITH A 0.035 GUIDE WIRE, THEREFORE, A HI-TORQUE .014 BMW GUIDE WIRE WAS USED. DURING ADVANCEMENT, RESISTANCE WAS FELT IN THE RADIAL ARTERY OF THE FOREARM AND WHEN THE GUIDE WIRE WAS REMOVED, IT WAS NOTICED THAT THE WIRE HAD BROKEN INTO TWO PIECES. THE SMALLER PIECE, (SLIGHTLY LARGER THAN THE RADIOPAQUE TIP) REMAINED IN THE PATIENT'S ARTERY. A VASCULAR SURGEON WAS REQUIRED TO MAKE AN INCISION AND REMOVE THE SEPARATED PIECE. THERE WAS NO MAJOR COMPLICATIONS; HOWEVER A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS REPORTED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167816 ↗
• MalfunctionMay 10, 2023Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT AN ANGIOPLASTY WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NONE TORTUOSITY AND NONE CALCIFICATION. THE 3CM HI-TORQUE 014 BMW HYDRO GUIDE WIRE WAS INTRODUCED WITH A 2.0X15MM NON-ABBOTT BALLOON AND AT THE DISTAL PART OF THE GUIDE THE NON-ABBOTT BALLOON BECAME STUCK AND COULD NOT ADVANCE FURTHER. BOTH DEVICES WERE REMOVED TOGETHER. ANOTHER HI-TORQUE 014 BMW HYDRO GUIDE WIRE WAS INTRODUCED WITH A 1.25X15MM NON-ABBOTT BALLOON; HOWEVER, ENCOUNTERED THE SAME ISSUE AND WERE REMOVED. IT WAS NOTED THAT THE DISTAL WELDS OF THE GUIDE WIRES WERE MORE EVIDENT VISUALLY AND TO THE TOUCH. ANOTHER HI-TORQUE 014 BMW 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 16903778 ↗
• MalfunctionMay 10, 2023Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT AN ANGIOPLASTY WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NONE TORTUOSITY AND NONE CALCIFICATION. THE 3CM HI-TORQUE 014 BMW HYDRO GUIDE WIRE WAS INTRODUCED WITH A 2.0X15MM NON-ABBOTT BALLOON AND AT THE DISTAL PART OF THE GUIDE THE NON-ABBOTT BALLOON BECAME STUCK AND COULD NOT ADVANCE FURTHER. BOTH DEVICES WERE REMOVED TOGETHER. ANOTHER HI-TORQUE 014 BMW HYDRO GUIDE WIRE WAS INTRODUCED WITH A 1.25X15MM NON-ABBOTT BALLOON; HOWEVER, ENCOUNTERED THE SAME ISSUE AND WERE REMOVED. IT WAS NOTED THAT THE DISTAL WELDS OF THE GUIDE WIRES WERE MORE EVIDENT VISUALLY AND TO THE TOUCH. ANOTHER HI-TORQUE 014 BMW 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 16903775 ↗