HI-TORQUE BALANCE MIDDLEWEIGHT 1001780JRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648025976), received between Feb 20, 2018 and Jun 5, 2025 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (13 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 25 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2025Off-Label Use; Material Separation; Failure to Advance; Off-Label Use; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE GREAT SAPHENOUS VEIN. DURING THE USE OF A 3CM 014 HT BALANCE MIDDLE WEIGHT GUIDE WIRE (GW) THE TIP OF THE WIRE WAS NOTED TO SEPARATE. THE SEPARATED PORTION WAS LEFT IN THE ANATOMY AND A COMPRESSIVE COBAN BANDAGE WAS APPLIED TO THE UPPER THIGH ALONG WITH A COMPRESSION SOCK TO ENSURE THE SEPARATED PORTION OF THE WIRE WOULD NOT MIGRATE. AFTER THE LOCATION OF THE SEPARATED WIRE WAS CONFIRMED UNDER ULTRASOUND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152722 ↗
• MalfunctionMay 16, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE HAD RESISTANCE DURING ADVANCEMENT AND NOTED TO HAVE DIFFICULTY DELIVERING ONTO A BALLOON AND STENT. TORQUE MOVEMENT WAS DIFFICULT DUE TO THE AMOUNT OF FORCE APPLIED AT THE PROXIMAL END WAS NOT TRANSFERRING TO THE DISTAL END. THE COATING WAS ALSO NOTED TO BE STICKING BETWEEN THE HARDWARE'S WITH RESISTANCE DURING REMOVAL BUT REMOVED INDEPENDENTLY. THE SAME GUIDE WIRE WAS 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 22039721 ↗
• MalfunctionOct 31, 2024Peeled/Delaminated; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHILE INSERTING THE HT BALANCE BMW GUIDEWIRE (GW) INTO THE INTRODUCER, A GREEN SUBSTANCE WAS NOTED TO BE PEELING IN THE INTRODUCER. THE GW WAS IMMEDIATELY REMOVED AND 3 ADDITIONAL BMW GW WERE ATTEMPTED TO BE USED AFTER THE SAME PEELING WAS NOTED; HOWEVER, ALL WERE NOTED TO HAVE THE SAME GREEN PEELING DURING INSERTION. ANOTHER GW WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20577670 ↗
• MalfunctionOct 31, 2024Peeled/Delaminated; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHILE INSERTING THE HT BALANCE BMW GUIDEWIRE (GW) INTO THE INTRODUCER, A GREEN SUBSTANCE WAS NOTED TO BE PEELING IN THE INTRODUCER. THE GW WAS IMMEDIATELY REMOVED AND 3 ADDITIONAL BMW GW WERE ATTEMPTED TO BE USED AFTER THE SAME PEELING WAS NOTED; HOWEVER ALL WERE NOTED TO HAVE THE SAME GREEN PEELING DURING INSERTION. ANOTHER GW WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20577669 ↗
• MalfunctionOct 31, 2024Peeled/Delaminated; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHILE INSERTING THE HT BALANCE BMW GUIDEWIRE (GW) INTO THE INTRODUCER, A GREEN SUBSTANCE WAS NOTED TO BE PEELING IN THE INTRODUCER. THE GW WAS IMMEDIATELY REMOVED AND 3 ADDITIONAL BMW GW WERE ATTEMPTED TO BE USED AFTER THE SAME PEELING WAS NOTED; HOWEVER ALL WERE NOTED TO HAVE THE SAME GREEN PEELING DURING INSERTION. ANOTHER GW WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20577639 ↗
• MalfunctionOct 31, 2024Peeled/Delaminated; Improper or Incorrect Procedure or Method; Peeled/Delaminated; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). WHILE INSERTING THE HT BALANCE BMW GUIDEWIRE (GW) INTO THE INTRODUCER, A GREEN SUBSTANCE WAS NOTED TO BE PEELING IN THE INTRODUCER. THE GW WAS IMMEDIATELY REMOVED AND 3 ADDITIONAL BMW GW WERE ATTEMPTED TO BE USED AFTER THE SAME PEELING WAS NOTED; HOWEVER ALL WERE NOTED TO HAVE THE SAME GREEN PEELING DURING INSERTION. ANOTHER GW WAS USED AND THE PROCEDURE WAS COMPLETED. 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 20577524 ↗
• MalfunctionApr 30, 2024Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THAT ONCE OPENING THE HT BALANCE MIDDLEWEIGHT GUIDE WIRE, IT WAS OBSERVED THAT THE DISTAL END (3 CENTIMETERS FROM THE TIP) THE COILS WERE STRETCHED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. RETURN DEVICE ANALYSIS NOTED THAT THE DISTAL SOLDER TIP WAS SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214512 ↗
• InjuryNov 19, 2023Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance; Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED WITH UNSPECIFIED RESISTANCE NOTED AND THEN WHEN REMOVED, THE GUIDE WIRE WAS UNRAVELED. ADDITIONALLY THE SHAPE RETENTION OF THE WIRE WAS NOT NORMAL AS WHEN THE WIRE WAS TAKEN OUT OF THE ANATOMY, IT WAS IN A "U" SHAPE. A SNARE WAS USED TO REMOVE THE GUIDE WIRE AS THERE WAS UNSPECIFIED RESISTANCE DURING REMOVAL. AN UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 18167278 ↗
• MalfunctionNov 19, 2023Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance; Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED AND THEN WHEN REMOVED, THE GUIDE WIRE WAS UNRAVELED. THERE WAS UNSPECIFIED RESISTANCE DURING ADVANCEMENT FOR BOTH WIRES. ADDITIONALLY THE SHAPE RETENTION OF THE WIRE WAS NOT NORMAL AS THE SHAPE WAS A "U" WHEN THE GUIDE WIRE WAS TAKEN OUT OF THE ANATOMY. THIS OCCURRED WITH A SECOND BMW GUIDE WIRE AS WELL. THERE WAS UNSPECIFIED RESISTANCE DURING REMOVAL FOR BOTH WIRES. REPORTEDLY, A SNARE WAS REQUIRED TO PULL BACK ONE OF THE WIRES. AN UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167274 ↗
• InjuryNov 19, 2023Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance; Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED AND THEN WHEN REMOVED, THE GUIDE WIRE WAS UNRAVELED. THERE WAS UNSPECIFIED RESISTANCE DURING ADVANCEMENT FOR BOTH WIRES. ADDITIONALLY THE SHAPE RETENTION OF THE WIRE WAS NOT NORMAL AS THE SHAPE WAS A "U" WHEN THE GUIDE WIRE WAS TAKEN OUT OF THE ANATOMY. THIS OCCURRED WITH A SECOND BMW GUIDE WIRE AS WELL. THERE WAS UNSPECIFIED RESISTANCE DURING REMOVAL FOR BOTH WIRES. REPORTEDLY, A SNARE WAS REQUIRED TO PULL BACK ONE OF THE WIRES. AN UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167272 ↗
• InjuryNov 19, 2023Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance; Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED WITH RESISTANCE NOTED JUST WITH THE GUIDE WIRE ITSELF AND THEN WHEN REMOVED THERE WAS RESISTANCE AGAIN WITH JUST THE GUIDE WIRE. THE GUIDE WIRE WAS UNRAVELED. A SNARE WAS USED TO REMOVE THE GUIDE WIRE AS IT WAS UNRAVELED. ADDITIONALLY THE SHAPE RETENTION OF THE WIRE WAS NOT NORMAL AS WHEN THE WIRE WAS TAKEN OUT OF THE ANATOMY, IT WAS IN A "U" SHAPE. THIS OCCURRED WITH A SECOND BMW GUIDE WIRE AS WELL BUT ONLY THE FIRST WIRE WAS REMOVED VIA SNARE. AN UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 18167268 ↗
• MalfunctionNov 19, 2023Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance; Break; Product Quality Problem; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED WITH RESISTANCE NOTED JUST WITH THE GUIDE WIRE ITSELF AND THEN WHEN REMOVED THERE WAS RESISTANCE AGAIN WITH JUST THE GUIDE WIRE. THE GUIDE WIRE WAS UNRAVELED. A SNARE WAS USED TO REMOVE THE GUIDE WIRE AS IT WAS UNRAVELED. ADDITIONALLY THE SHAPE RETENTION OF THE WIRE WAS NOT NORMAL AS WHEN THE WIRE WAS TAKEN OUT OF THE ANATOMY, IT WAS IN A "U" SHAPE. THIS OCCURRED WITH A SECOND BMW GUIDE WIRE AS WELL BUT ONLY THE FIRST WIRE WAS REMOVED VIA SNARE. AN UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 18167265 ↗
• MalfunctionMay 12, 2023Difficult to Remove; Difficult to Remove

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THE NC TREK BALLOON WAS SLOW TO DEFLATE AND REMOVED FULLY DEFLATED THROUGH THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920185 ↗
• MalfunctionApr 24, 2023Product 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 RIGHT CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. AFTER CROSSING THE MID LESION WITH A BALANCE MIDDLEWEIGHT (BMW) .014 GUIDE WIRE, THE 3.0X12MM NC TRAVELER WAS USED FOR PRE-DILATATION. RESISTANCE WAS MET DURING ADVANCEMENT AND REMOVAL ON THE GUIDE WIRE. AFTER STENT DEPLOYMENT, A 3.5X8MM NC TRAVELER WAS USED FOR POST-DILATATION. THE SAME RESISTANCE WAS FOUND DURING ADVANCEMENT AND RETRACTION AND THE BALLOON BECAME STUCK ON THE BMW GUIDE WIRE. BOTH THE BALLOON AND GUIDE WIRE WERE REMOVED TOGETHER FROM THE GUIDE CATHETER TO PREVENT DAMAGING THE ARTERY. AFTER REMOVAL OF THE DEVICES, BASED ON THE TACTILE FEEL OF THE GUIDE WIRE, IT WAS THOUGHT THAT THE NC TRAVELER BALLOON WAS CATCHING THE GUIDE WIRE FIRMLY AND WAS REMOVING HYDROPHILIC COATING ON THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16799756 ↗
• MalfunctionFeb 20, 2023Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THROUGH A RADIAL APPROACH, A 3.5X38 MM XIENCE PRIME STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, THE SDS COULD NOT MOVE FORWARD FROM A PARTICULAR POINT OF THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE EVEN AFTER CONTINUOUS ATTEMPTS. THE BMW GUIDE WIRE WAS REMOVED WITH RESISTANCE NOTED WITH THE GUIDE CATHETER SO THEY WERE REMOVED TOGETHER AND UPON INSPECTION THERE WAS COATING PEELED OFF. ANOTHER BMW GUIDE WIRE WAS USED; HOWEVER IT HAD THE SAME RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404591 ↗
• MalfunctionFeb 20, 2023Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THROUGH A RADIAL APPROACH, A 3.5X38 MM XIENCE PRIME STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, THE SDS COULD NOT MOVE FORWARD FROM A PARTICULAR POINT OF THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE EVEN AFTER CONTINUOUS ATTEMPTS. THE BMW GUIDE WIRE WAS REMOVED WITH RESISTANCE NOTED WITH THE GUIDE CATHETER SO THEY WERE REMOVED TOGETHER AND UPON INSPECTION THERE WAS COATING PEELED OFF. ANOTHER BMW GUIDE WIRE WAS USED; HOWEVER IT HAD THE SAME RESULT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404571 ↗
• InjuryNov 22, 2022Difficult to Remove; Material Separation; Deformation Due to Compressive Stress; Difficult to Remove; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). THE 0.014 BMW GUIDEWIRE (GW) WAS POSITIONED WITHOUT ISSUE. AFTER STENT PLACEMENT AND POST DILATATION WITH A NON-COMPLIANT BALLOON, DURING REMOVAL OF THE GW, RESISTANCE WAS NOTED. UPON REMOVAL, THE GW WAS NOTED TO HAVE SOME DEFORMITY AND THE TIP OF THE GW SEPARATED BUT REMAINED AT THE ENTRANCE OF THE RCA. UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE SEPARATED TIP, AS THE PIECE WAS TOO SMALL AND COULD NOT BE SNARED. ANGIOPLASTY WAS PERFORMED IN AN ATTEMPT TO EMBED THE SEPARATED PORTION OF WIRE INTO THE VESSEL WALL, BUT INSTEAD OF EMBEDDING THE SEPARATED PORTION, IT MIGRATED TO THE LEVEL OF THE VALSALVA SINUS. THE PATIENT REMAINED HOSPITALIZED, UNRELATED TO THE ANGIOPLASTY, BUT IT WAS NOTED THAT THE SEPARATED PORTION OF WIRE REMAINED STABLE WITHOUT FURTHER EMBOLIZATION OR MIGRATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15849191 ↗
• InjuryNov 22, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 014 HT BMW J GUIDE WIRE (GW) WAS ADVANCED; HOWEVER, RESISTANCE WAS MET WITH THE CALCIFIED VESSEL AND WHILE PUSHING TOWARDS THE TARGET LESION, IT WAS NOTED THAT HALF OF THE RADIO OPAQUE TIP SEPARATED IN THE ANATOMY. THE GUIDE WIRE WAS REMOVED FROM THE ANATOMY, WITH THE SEPARATED SEGMENT REMAINING IN THE MRCA. A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND THE SEPARATED TIP WAS EMBEDDED IN THE VESSEL WALL WITH AN UNSPECIFIED STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15848779 ↗
• InjuryOct 5, 2022Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 60% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 014 BMW 3CM GUIDE WIRE (GW) WAS ADVANCED BEYOND THE TARGET LESION AND USED FOR THE PROCEDURE WITHOUT ISSUE. DURING REMOVAL, THE GUIDE WIRE BECAME STUCK AT THE DISTAL LEVEL OF THE VESSEL AND COULD NOT BE REMOVED. AN UNSPECIFIED BALLOON WAS ADVANCED TO TRY TO FREE THE GUIDE WIRE, BUT THE RADIOPAQUE PART OF THE GUIDE WIRE SEPARATED AND FRAYED IN THE ANATOMY. TWO STENTS WERE IMPLANTED, ONE DOWNSTREAM AND ONE UPSTREAM OF THE SEPARATED GUIDE WIRE SEGMENT, TO EMBED IT IN THE WALL OF THE VESSEL AND PREVENT FUTURE MIGRATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15547505 ↗
• InjuryOct 5, 2022Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: MDR REPORT #: MW5111748. DURING PCI (PERCUTANEOUS CORONARY INTERVENTION) FOR AN ACUTE MI (MYOCARDIAL INFARCTION), THE END OF THE GUIDEWIRE CAUGHT ON THE STENT LEAVING A PORTION OF THE GUIDEWIRE REMAINING CAUGHT ON THE STENT. 0.014" GUIDEWIRE. FDA SAFETY REPORT ID # (B)(4). ADDITIONALLY, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. AFTER THE GUIDE WIRE SEPARATED, A SNARE WAS ADVANCED TO THE SEPARATED PORTION OF WIRE AND A SMALL PIECE WAS ABLE TO BE SNARED AND REMOVED; HOWEVER, ANOTHER SMALL PIECE OF WIRE WAS LEFT EMBEDDED BEHIND THE IMPLANTED STENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR SECOND OPINION RELATED TO THIS INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15547142 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SITU AT POINT OF ELBOW (VIA RADIAL ACCESS). A BALLOON INITIALLY PASSED ON THE GUIDE WIRE WITHOUT COMPLICATIONS, BUT THEN BECAME STUCK AT THE SOLDER POINT OF THE GUIDE WIRE. AFTER PULLING OUT THE GUIDE WIRE FROM THE ANATOMY, IT WAS NOTED THERE WAS A PALPABLE LUMP ON THE SOLDER POINT OF THE WIRE. SOLDER POINT APPEARED TO EXPAND WITH BODY HEAT. THE ACCOUNT CONFIRMED THERE WAS NO DEVICE SEPARATION OR PEELING OF THE COATING. ANOTHER BMW 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14982663 ↗
• InjurySep 20, 2021Material Separation; Material Separation

  USER FACILITY MEDWATCH REPORT (B)(4) RECEIVED THAT STATES: GUIDE WIRE SHEARED OFF IN THE CORONARY. AFTER MULTIPLE ATTEMPTS WITH SNARE DEVICE, WIRE PIECE WAS ABLE TO BE RETRIEVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12499554 ↗
• MalfunctionMay 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A MULTI-VESSEL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED ON AN 80% STENOSED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY AND A MILDLY TORTUOUS LESION IN THE LEFT CIRCUMFLEX ARTERY. IN TRYING TO TREAT THE MILDLY TORTUOUS RIGHT CORONARY ARTERY, THE 014 HI-TORQUE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS BEING RE- INTRODUCED INTO THE GUIDING CATHETER; HOWEVER, THE DISTAL PORTION OF THE GUIDE WIRE WAS NOTED TO HAVE SEPARATED BEFORE ENTERING THE PATIENT ANATOMY AND WAS SIMPLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED BMW GUIDE WIRE. 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 10068119 ↗
• MalfunctionFeb 20, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. IT WAS NOTED THAT DURING AN ATTEMPT TO SHAPE THE TIP OF A BALANCE MIDDLEWEIGHT 014 (BMW) GUIDE WIRE (OUTSIDE OF THE ANATOMY), THE TIP WAS NOTED TO BE PEELING. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER BMW 014 GUIDE WIRE; BUT PEELING OF THE TIP WAS ALSO NOTED ON THIS DEVICE. ANOTHER UNSPECIFIED BMW GUIDE WIRE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7282482 ↗
• MalfunctionFeb 20, 2018Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. IT WAS NOTED THAT DURING AN ATTEMPT TO SHAPE THE TIP OF A BALANCE MIDDLEWEIGHT 014 (BMW) GUIDE WIRE (OUTSIDE OF THE ANATOMY), THE TIP WAS NOTED TO BE PEELING. THEREFORE, THE DEVICE WAS REPLACED WITH ANOTHER BMW 014 GUIDE WIRE; BUT PEELING OF THE TIP WAS ALSO NOTED ON THIS DEVICE. ANOTHER UNSPECIFIED BMW GUIDE WIRE WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7282407 ↗