HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009666JRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 08717648118777), received between Mar 8, 2018 and Jul 28, 2026 — classified as 13 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (25 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Difficult to Remove; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059533 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT II GUIDEWIRE RUPTURED [SEPARATED] DURING USE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054404 ↗
• MalfunctionMar 13, 2025Break; Material Separation; Difficult to Advance; Break; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNKNOWN VESSEL. A 190CM HT BMW GUIDEWIRE WAS ADVANCE INTO THE ANATOMY; HOWEVER, RESISTANCE WAS NOTED AT THE WELD POINT ON THE DEVICE WHEN A BALLOON CATHETER WAS ADVANCED OVER THE WIRE. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH A WHISPER GUIDEWIRE AND THE PROCEDURE WAS COMPLETED . THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. SUBSEQUENT TO THE INITIALLY REPORTED EVENT, THE DEVICE WAS RECEIVED AND THE ANALYSES REVEALED THE DISTAL SOLDER TIP WAS SEPARATED FROM DISTAL END OF COILS. THERE WAS REMNANT OF SOLDER ON THE DISTAL END OF COILS. THE SOLDER TIP WAS NOT RETURNED, AND THERE WAS A BREAK IN THE COILS AT 5CM (CENTIMETERS) PROXIMALLY FROM DISTAL END OF GUIDEWIRE. CONFIRMATION OF THE ADDITIONAL DAMAGES WERE UNABLE TO BE CONFIRMED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598354 ↗
• InjuryFeb 20, 2025Difficult to Remove; Material Separation; Failure to Advance; Difficult to Advance; Material Too Soft/Flexible; Difficult to Remove; Material Separation; Failure to Advance; Difficult to Advance; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY WITH MILD CALCIFICATION. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE HAD RESISTANCE WITH THE ANATOMY AND GUIDING CATHETER DURING ADVANCEMENT. THE TIP WAS FLOPPY AND MATERIAL FATIGUE WAS NOTED. THEREFORE, A DECISION WAS MADE TO REMOVE THE GUIDEWIRE, BUT RESISTANCE WAS FELT WITH THE GUIDING CATHETER. THEN THE JUNCTION BETWEEN THE TIP AND THE RIGID BODY OF THE GUIDEWIRE [SHAFT] BECAME SEPARATED DURING REMOVAL. INTERVENTION WAS PERFORMED USING A SNARE DEVICE AND SEPARATED PORTION WAS REMOVED FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 21422466 ↗
• InjuryFeb 7, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II W/O MARK 190CM J GUIDE WIRE (GW) WAS USED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE GUIDE WIRE MET RESISTANCE WITH AN UNSPECIFIED SOURCE WHILE ADVANCING TO THE LESION. THE WIRE BECAME SEPARATED IN THE DISTAL PART OF THE LESION AND WAS OBSERVED ON FLUOROSCOPY. A SNARE DEVICE WAS ADVANCED VIA THE FEMORAL ROUTE AND USED TO REMOVE PART OF THE GUIDE WIRE; HOWEVER, A FRAGMENT OF THE WIRE REMAINED IN THE VESSEL WITHOUT COMPROMISING THE FLOW. AN INCREASE IN THE USE OF ANTIPLATELET MEDICATION WAS PROVIDED TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21334676 ↗
• InjuryJan 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE DETACHED AT THE TIP WHILE IN THE VESSEL. TREATMENT, IF ANY, WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21268554 ↗
• MalfunctionNov 19, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE BMW UNIVERSAL II GUIDE WIRE WAS ADVANCED INTO THE PATIENT ANATOMY AND AN ATTEMPT WAS MADE TO ADVANCE A NON-ABBOTT BALLOON CATHETER OVER THE GUIDE WIRE HOWEVER RESISTANCE WAS NOTED THEREFORE THE BALLOON CATHETER WAS REMOVED. A SECOND BMW UNIVERSAL II GUIDE WIRE WAS USED HOWEVER THE SAME NON-ABBOTT BALLOON CATHETER MET RESISTANCE AND BECAME STUCK ON THE GUIDE WIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THE PROCEDURE WAS COMPLETED USING A WHISPER GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS OF THE SECOND BMW UNIVERSAL II GUIDE WIRE NOTED CORROSION ON THE PROXIMAL SOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722598 ↗
• InjuryOct 21, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED POSTERIOR DESCENDING BRANCH OF THE RIGHT CORONARY ARTERY (RCA). DURING REMOVAL, WHEN THE GUIDE WIRE MET WITH RESISTANCE, FORCE WAS APPLIED. THE SEPARATED PORTION OF THE GW WAS EMBEDDED IN THE DISTAL PORTION OF THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20497285 ↗
• MalfunctionJun 27, 2024Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  RETURNED DEVICE ANALYSIS NOTED THAT THE NC TREK BALLOON OUTER MEMBER RETURNED TORN AND THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE POLYMER COATING WAS SEPARATED; HOWEVER, STILL HELD BY THE GUIDE WIRE CORE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19628559 ↗
• MalfunctionFeb 8, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE HT BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE BECAME FRAYED DURING THE PASSAGE OF THE BALLOON CATHETER. THEREFORE, A NEW UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672746 ↗
• InjuryDec 19, 2023Peeled/Delaminated; Difficult to Remove; Difficult to Advance; Peeled/Delaminated; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED DURING THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS ANTERIOR DESCENDING ARTERY. THE HT BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS ALREADY IN POSITION AND UNSPECIFIED BALLOON COULD NOT LONGER PROGRESS NOR RETRACT; THEREFORE, THE ENTIRE ASSEMBLY WAS REMOVED. ONCE REMOVED, PART OF THE TEFLON COATING HAD PEELED OFF AND CANNOT BE CONFIRMED IF ANY COATING WAS LEFT IN THE PATIENT. ANOTHER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18356611 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144989 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED IN A GENERAL COMMENT THAT DURING PROCEDURES OF GREATER COMPLEXITY, THE BALANCE MIDDLEWEIGHT (BMW), BMW UNIVERSAL II, BALANCE HEAVYWEIGHT, WHISPER MS AND WHISPER EXTRA SUPPORT GUIDE WIRES LOSE THEIR HYDROPHILICITY. THERE IS RESISTANCE WITH BALLOONS, STENTS AND IMAGING CATHETERS AND THE GUIDE WIRES ARE SIMPLY REMOVED WITH THE OTHER DEVICE AS A SINGLE UNIT BECAUSE THE DEVICES ARE STUCK TO EACH OTHER. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LENGTH OF THE PROCEDURE IS EXTENDED AND THERE IS GREATER EXPOSURE TO X RAYS BUT THERE IS NO CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144730 ↗
• MalfunctionOct 10, 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 A LESION IN THE CIRCUMFLEX (CX) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE WAS NOTED TO HAVE DELAMINATED CATCHING ON THE ULTRASOUND GUIDED CATHETER. THE BLACK POLYMER COATING WAS NOTED TO HAVE PEELED. THE GUIDE WIRE AND THE ULTRASOUND GUIDED CATHETER WERE REMOVED AS A UNIT AND MANAGING TO BE REMOVED WITH ABRUPT FORCE. ANOTHER NON-ABBOTT 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 17908948 ↗
• MalfunctionSep 20, 2023Peeled/Delaminated; Difficult to Advance; Peeled/Delaminated; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE 60% STENOSED LESION IN THE MIDDLE THIRD RIGHT CORONARY ARTERY AND CIRCUMFLEX ARTERY. THE HT BMW UNIVERSAL II GUIDE WIRE WAS POSITIONED; HOWEVER, THE BALLOON CATHETER COULD NOT BE PROGRESSED AND RESISTANCE BETWEEN THE DEVICES WAS FELT DURING ADVANCEMENT. WHEN REMOVING THE ENTIRE ASSEMBLY, IT WAS NOTICED THAT THE GUIDE WIRE TIP POLYMER WAS PEELED. NO POLYMER WAS LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786297 ↗
• MalfunctionSep 18, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE DESCENDING ARTERY. THE HT BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE WAS PLACED AND THE HYDROPHILIC COATING BEGAN TO GRAB [HAVE RESISTANCE] DURING ADVANCEMENT AND REMOVAL; HOWEVER, WAS REMOVED AS A SINGLE UNIT. ANOTHER PILOT 50 GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE; HOWEVER, THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769489 ↗
• MalfunctionSep 18, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE ACCOUNT STATED THAT THERE WAS NO ADVERSE PATIENT EFFECT DUE TO THE ADDITIONAL CONTRAST AND FLUOROSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17768993 ↗
• MalfunctionAug 30, 2023Contamination /Decontamination Problem; Difficult to Advance; Contamination /Decontamination Problem; Difficult to Advance

  IT WAS REPORTED THAT THE HT BMW UNIVERSAL II GUIDE WIRE (GW) WAS USED IN A CORONARY ANGIOPLASTY PROCEDURE AND RESISTANCE WAS MET WHEN AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED ON THE GW. WHEN THE GW WAS REMOVED FROM THE PATIENT, A WHITISH SUBSTANCE WAS OBSERVED ON THE GW. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653176 ↗
• InjuryAug 14, 2023Stretched; Material Split, Cut or Torn; Stretched; Material Split, Cut or Torn

  SUBSEQUENT TO INITIAL REPORT BEING FILED ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED COILS BECAME "EXPOSED" MEANT THE COILS OF THE GUIDE WIRE WERE STRETCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 17541635 ↗
• MalfunctionJul 20, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75-90% STENOSED LESION IN THE MID DIAGONAL CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. DURING USE OF A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE, THE WIRE BECAME STUCK WITH AN UNSPECIFIED BALLOON CATHETER DURING DESCENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THERE WAS RESISTANCE WITH THE BALLOON DURING ADVANCEMENT AND REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17364096 ↗
• MalfunctionJul 20, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE HAD CROSSED THE LESION BUT AN UNSPECIFIED BALLOON WAS STUCK ON THE GUIDE WIRE DURING ADVANCEMENT AND REMOVAL. THE DEVICES WERE REMOVED TOGETHER AND A NEW GUIDE WIRE WAS USED TO 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 17357475 ↗
• InjuryJul 19, 2023Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID DESCENDING CORONARY ARTERY WITH NO CALCIFICATION AND SIGNIFICANT TORTUOSITY. DURING USE OF A BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE, THE WIRE BECAME STUCK WITH AN UNSPECIFIED BALLOON. UPON INDEPENDENT REMOVAL OF THE GUIDE WIRE, IT WAS NOTED THAT THE TIP COVER HAD PEELED OFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THE TEFLON WAS PEELING. THERE IS THE POTENTIAL SOME MATERIAL REMAINS IN THE PATIENT AS IT CANNOT BE SEEN ON FLUOROSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17351935 ↗
• MalfunctionJul 7, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A FIBRO-CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH MILD TORTUOSITY AND NO CALCIFICATION. THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE CROSSED THE LESION, HOWEVER, A BALLOON GOT STUCK WITH THE GUIDE WIRE AND THE TWO DEVICES WERE REMOVED AS A SINGLE UNIT. ANOTHER SAME SIZE HT BMW UNIVERSAL II GUIDE WIRE WAS 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 17282740 ↗
• InjuryJan 16, 2023Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Stretched; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. AFTER STENTING AND REMOVING THE BALLOON, DURING REMOVAL OF THE HI-TORQUE (HT) BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE, THE GUIDEWIRE BECAME STUCK IN THE POSTERIOR LATERAL BRANCH OF THE RCA. AFTER A FEW ATTEMPTS OF PULLING THE GUIDEWIRE WITH SLIGHT FORCE, IT UNRAVELED AS IT WAS REMOVED FROM THE GUIDE CATHETER. THE RADIOPAQUE TIP OF THE GUIDEWIRE WAS VISIBLE ON ANGIOGRAM IN THE DISTAL PORTION OF THE RCA EXTENDING THROUGHOUT THE ENTIRE VESSEL. AN ATTEMPT WAS MADE TO REMOVE THE LOST PIECE OF GUIDEWIRE; HOWEVER, IT WAS UNSUCCESSFUL. THE PATIENT WAS KEPT AN ADDITIONAL NIGHT IN THE HOSPITAL TO RETURN TO THE CATH LAB THE NEXT DAY AS THE PHYSICIAN REQUESTED HELP FROM ANOTHER PHYSICIAN AND NEEDED ADDITIONAL SUPPLIES. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GUIDEWIRE WITH A SNARE DEVICE AND THE ADDITIONAL SUPPLIES BUT THE ATTEMPTS WERE UNSUCCESSFUL AND THE GUIDEWIRE WAS LEFT FREE-FLOATING IN THE PATIENT ANATOMY. THE PHYSICIAN THINKS THE GUIDEWIRE BROKE OFF AT THE RADIOPAQUE WELD AND UNRAVELED IN THE VESSEL AS IT WAS PULLED OUT OF THE GUIDE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16174100 ↗
• MalfunctionOct 26, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE FIRST DIAGONAL (1ST) ARTERY. A 2.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR POST-DILATATION, HOWEVER THE BDC MET RESISTANCE WITH THE HT BMW UNIVERSAL II GUIDE WIRE (GW) AND BECAME STUCK ON THE GUIDE WIRE PREVENTING IT FROM REACHING THE TARGET LESION. THE BDC WAS INFLATED ONE TIME, CLOSE TO THE TARGET LESION, HOWEVER THE BALLOON DID NOT DEFLATE. DAMAGE WAS NOTED TO THE SHAFT OF THE BDC WHICH WAS PREVENTING THE BALLOON FROM DEFLATING. THE INFLATED BALLOON AND THE GUIDE WIRE WERE REMOVED FROM THE ANATOMY. A 190CM J BMW UNIVERSAL II GW WAS THEN ADVANCED TO THE TARGET LESION WITH RESISTANCE MET FROM THE ANATOMY AND AN ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE TEFLON COATING WAS SCRATCHED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677706 ↗