HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009660Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 08717648014338), received between Jan 5, 2017 and Jul 20, 2026 — classified as 34 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (50 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25873527 ↗
• MalfunctionJan 23, 2026Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY. THE BMW UNIVERSAL WAS USED DURING THE PROCEDURE ALONG WITH A RUN THROUGH GUIDE WIRE HOWEVER DURING REMOVAL THE WIRES BECAME ENTANGLED AND THE TIP OF THE BMW UNIVERSAL BROKE OFF. 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 24160321 ↗
• MalfunctionDec 29, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  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) UNIVERSAL GUIDEWIRE CROSSED A STENT WAS IMPLANTED A COUPLE OF DAYS AGO; HOWEVER, THERE WAS RESISTANCE AT THE LOCATION OF THE STENT UPON RETRIEVAL OF THE GUIDEWIRE. THE BMW UNIVERSAL WAS REMOVED INDEPENDENTLY BUT THE TIP/COILS WERE STRETCHED/STRIPPED AND CORE BROKEN BUT HELD BY THE STRETCHED COILS. ANOTHER NON-ABBOTT GUIDEWIRE 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 23908911 ↗
• MalfunctionDec 17, 2025Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING REMOVAL OF THE BMW UNIVERSAL GUIDE WIRE, RESISTANCE WAS MET WITH THE LESION. ONCE REMOVED FROM THE PATIENT, IT WAS NOTED THE TIP COILS WERE STRETCHED. ANOTHER GUIDE WIRE 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 23827932 ↗
• InjuryDec 10, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE 190 CM BMW GUIDE WIRE TIP WAS SEPARATED AND NOT RETURNED. THE ACCOUNT STATED THAT THE WIRE SEPARATED AT THE BEGINNING OF THE CASE AFTER THE WIRE BECAME STUCK ON CALCIUM. THE SEPARATED PIECE COULD NOT BE LOCATED OR SEEN ON FLUORO. THE 300CM GUIDE WIRE TIP WAS ALSO SEPARATED AND NOT RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23773855 ↗
• MalfunctionDec 10, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALANCE MIDDLEWEIGHT GUIDEWIRE WAS USED WITH A NON-ABBOTT BALLOON AND HAD TO BE REMOVED TOGETHER AS ONE UNIT. AN UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 23767169 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THE SEPARATED PIECE WAS REMOVED WHEN THE WIRE WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619381 ↗
• MalfunctionOct 28, 2025Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED AND TORTUOUS CIRCUMFLEX ARTERY. THE 2.50X15MM NC SCOREFLEX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE BMW UNIVERSAL GUIDE WIRE TO THE TARGET LESION. AFTER SUCCESSFUL DILATATION, AN ATTEMPT WAS MADE TO REMOVE THE SCOREFLEX FROM THE GUIDE WIRE HOWEVER IT REMAINED STUCK. THE DEVICES WERE REMOVED TOGETHER AND OUTSIDE THE ANATOMY IT WAS NOTED THE GUIDE WIRE WAS STRETCHED AND UNRAVELED HOWEVER REMAINED IN ONE PIECE. 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 23401964 ↗
• MalfunctionAug 27, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT MAIN (LM) ARTERIES. AFTER ROTABLATION, THE 3.5X20MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON A HI-TORQUE BMW UNIVERSAL 190CM GUIDE WIRE (GW). THE BDC WAS USED IN THE PROCEDURE; HOWEVER, WHEN ATTEMPTING TO DEFLATE THE BALLOON FOR 2-3 SECONDS, THE BALLOON WOULD NOT FULLY DEFLATE. AN ATTEMPT WAS MADE TO REMOVE THE BDC FROM THE GW; HOWEVER, THE DEVICE COULD NOT BE REMOVED FROM EACH OTHER AND RESISTANCE WAS NOTED BETWEEN THE DEVICES. AFTER, SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO REMOVED THE PARTIALLY DEFLATED BALLOON WITH THE GW AND 7 FR GUIDE CATHETER (GC) AS AS A SINGLE UNIT. THE PROCEDURE WAS CONTINUED WITH ANOTHER NC TREK NEO BDC. 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 22910186 ↗
• MalfunctionJul 31, 2025Break; Stretched; Material Twisted/Bent; Break; Stretched; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO USE TO THE HI-TORQUE BMW UNIVERSAL 190CM GUIDE WIRE (GW), THE GW STARTED TO BREAK BUT REMAINED IN ONE PIECE. THE GW WAS NOT USED IN THE PROCEDURE. ANOTHER BMW GW WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674747 ↗
• MalfunctionJul 8, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE HT COMMAND 14 GUIDE WIRE WAS ADVANCED WITH A 2.50X15MM BALLOON CATHETER TO THE TARGET LESION. AFTER INFLATING THE BALLOON TO 18 ATMOSPHERES, THE GUIDE WIRE STUCK TO THE BALLOON CATHETER AND THE TIP SEPARATED. THE SEPARATED GUIDE WIRE WAS REMOVED WITH THE BALLOON CATHETER. 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 22435315 ↗
• InjuryApr 24, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BMW GUIDE WIRE (GW) WAS ADVANCED; HOWEVER THE TIP BECAME CAUGHT. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GW BUT THE TIP SEPARATED. A STENT WAS DEPLOYED TO SECURE THE SEPARATED PORTION OF THE GW AGAINST THE VESSEL WALL. A SECOND BMW GW WAS ADVANCED WITHOUT RESISTANCE BUT THE TIP OF THE GW BECAME CAUGHT AND ALSO SEPARATED. THE SEPARATED TIP WAS LEFT IN THE PATIENT. A SECOND PROCEDURE WAS PERFORMED 3 DAYS LATER WHERE ANOTHER STENT WAS IMPLANTED TO SECURE THE SEPARATED TIP AGAINST THE VESSEL WALL. 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 21899498 ↗
• InjuryApr 24, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE BMW GUIDE WIRE (GW) WAS ADVANCED; HOWEVER THE TIP BECAME CAUGHT. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GW BUT THE TIP SEPARATED. A STENT WAS DEPLOYED TO SECURE THE SEPARATED PORTION OF THE GW AGAINST THE VESSEL WALL. A SECOND BMW GW WAS ADVANCED WITHOUT RESISTANCE BUT THE TIP OF THE GW BECAME CAUGHT AND ALSO SEPARATED. THE SEPARATED TIP WAS LEFT IN THE PATIENT. A SECOND PROCEDURE WAS PERFORMED 3 DAYS LATER WHERE ANOTHER STENT WAS IMPLANTED TO SECURE THE SEPARATED TIP AGAINST THE VESSEL WALL. 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 21899495 ↗
• MalfunctionApr 2, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. A BALANCE MIDDLEWEIGHT GUIDE WIRE WAS IN PLACE IN THE LAD AND DURING WITHDRAWAL OF THE 4X20 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) ALONG THE GUIDE WIRE, THERE WAS RESISTANCE. UPON SIMPLE REMOVAL WITHOUT FORCE FROM THE ANATOMY IT WAS NOTED A PIECE OF THE BMW GUIDE WIRE HAD TORN OFF. NO MATERIAL WAS LEFT IN THE PATIENT. 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 21756103 ↗
• MalfunctionApr 2, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. ACCESS TO THE LESION WAS GAINED USING A NON-ABBOTT GUIDE WIRE (GW), THEN THE HI- TORQUE BMW UNIVERSAL GW WAS ADVANCED AS A BUDDY WIRE TO THE TARGET LESION. THE LESION WAS SUCCESSFULLY TREATED WITH A NON- ABBOTT STENT; HOWEVER, DURING THE REMOVAL OF THE BMW GW RESISTANCE WAS NOTED WITH THE GUIDE CATHETER; SUBSEQUENTLY, CAUSING THE CORE [COILS] OF THE GW TO UNRAVEL AND BECOME SEPARATED INSIDE THE GUIDE CATHETER. THEREFORE, THE GUIDING CATHETER AND SEPARATED GW WERE REMOVED AS A SINGLE UNIT. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755665 ↗
• MalfunctionDec 16, 2024Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON CALCIFIED, NON TORTUOUS RIGHT CORONARY ARTERY. THE 0.014" 190CM HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDEWIRE WAS NOTED NOT TO ADVANCE IN THE DIRECTION DESIRED; HOWEVER, NO RESISTANCE WAS NOTED. AFTER ADVANCING AND RETRACTING THE GUIDEWIRE SEVERAL TIMES, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE UNRAVELED DURING REMOVAL AND THE CORE BROKE, HOWEVER REMAINED IN ONE PIECE. THE GUIDEWIRE WAS THEN WITHDRAWN AND ANOTHER UNSPECIFIED GUIDEWIRE 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 20943202 ↗
• InjuryNov 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN THE HI-TORQUE BMW UNIVERSAL 190CM GUIDE WIRE WAS INSERTED INTO THE PATIENT, IT WAS NOTED ON X-RAY THAT THE TIP OF THE GUIDE WIRE SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED TIP. ANOTHER BMW GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. 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 20790931 ↗
• InjuryApr 9, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  MEDWATCH UF/IMPORTER REPORT# MW5152302 STATES: PATIENT WAS HAVING A CARDIAC CATHETERIZATION. A DRUG-ELUTING STENT WAS BEING PLACED IN THE OBTUSE MARGINAL. PROCEDURE WAS COMPLICATED BY GUIDEWIRE FRACTURE RESULTING IN A 15CM BREAK IN THE WIRE. THE COMPUTED TOMOGRAPHY ANGIOGRAPHY POST PROCEDURE CONFIRMED AN INTRA-AORTIC WIRE SHAPED FOREIGN BODY ORIGINATING IN THE LEFT CORONARY ARTERY EXTENDING INTO THE ASCENDING THORACIC AORTA AND TERMINATING IN THE MID TO DISTAL DESCENDING THORACIC AORTA. INDIVIDUAL HAD TO BE TRANSFERRED TO ANOTHER FACILITY WITH TCV SERVICES. ADDITIONAL INFORMATION WAS PROVIDED: IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE OBTUSE MARGINAL. A DRUG-ELUTING STENT WAS PLACED. THE BMW UNIVERSAL GUIDE WIRE WAS ADVANCED HOWEVER MET RESISTANCE AT THE CORONARY ARTERY BY PASS GRAFT. RESISTANCE WAS MET DURING RETRACTION AND THE GUIDE WIRE SEPARATED. ATTEMPTS TO RETRIEVE THE SEPARATED PORTION WERE UNSUCCESSFUL AND THE GUIDE WIRE REMAINED EMBEDDED IN THE MID TO DISTAL DESCENDING THORACIC AORTA. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19071389 ↗
• InjuryMar 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED OSTIUM-PROXIMAL SEGMENT AND THE DISTAL OSTIUM MARGINAL WAS NOTED TO BE TORTUOUS. DURING THE REMOVAL OF THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DISTAL END SEPARATED (APPROXIMATELY 30MM) AND REMAINED IN THE ANATOMY. ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION (SNARING, BALLOON TRAPPING, MULTIPLE WIRE WRAPPING); HOWEVER, WERE UNSUCCESSFUL; THEREFORE, A STENT WAS DEPLOYED TO EMBED THE SEPARATED PORTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18880704 ↗
• InjuryFeb 1, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE BMW GUIDE WIRE WAS ADVANCED. A STENT WAS ATTEMPTED TO BE ADVANCED, BUT COULD NOT ADVANCE ON GW. THE GUIDE WIRE WAS REMOVED FROM THE PATIENT AND A KINK WAS NOTED 15 CM FROM THE TIP OF THE GW. ANOTHER BMW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. RETURN DEVICE ANALYSIS FOUND THE POLYMER COATING WAS NOTED TO BE FOLDED OVER ITSELF IN THE NITINOL CORE AREA. THE POLYMER COATING MATERIAL IN THE FOLDED OVER WAS NOTED TO HAVE MULTIPLE TEARS. AS BLUE POLYMER CODING IS NOT VISIBLE IN THE PATIENT IT IS UNKNOWN IF ANY COATING REMAINED INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18624558 ↗
• InjuryFeb 1, 2024Entrapment of Device; Stretched; Difficult to Advance; Entrapment of Device; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE HI-TORQUE BMW UNIVERSAL 190CM GUIDEWIRE (GW) WAS ADVANCED TO THE TARGET LESION AND RESISTANCE WAS NOTED WITH ANATOMY AND THE GW BECAME STUCK [TRAPPED] IN THE VESSEL. ANOTHER BMW GUIDEWIRE WAS USED TO REMOVE THE GUIDEWIRE. THERE WAS NO ADVERSE PATIENT ADVERSE PATIENT SEQUELA. ANOTHER GUIDEWIRE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624328 ↗
• MalfunctionDec 13, 2023Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT HT BALANCE MIDDLEWEIGHT GUIDE WIRE SHAFT FRACTURED WHEN ADVANCING OVER THE GUIDE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY 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 18319588 ↗
• MalfunctionOct 4, 2023Difficult to Remove; Material Separation; Material Too Soft/Flexible; Difficult to Remove; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE BMW UNIVERSAL GUIDEWIRE WAS ADVANCED TO THE DISTAL LAD AND INTO A SMALL DIAGONAL BRANCH. THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ADVANCED AND AN OPTICAL COHERENCE TOMOGRAPHY (OCT) RUN WAS OBTAINED. WHEN REMOVING THE OCT CATHETER, THE GUIDEWIRE WAS UNINTENTIONALLY WITHDRAWN WITH THE DRAGONFLY CATHETER TO THE POINT THAT THE COIL OF THE GUIDEWIRE WAS INSIDE THE RAPID EXCHANGE PORTION OF THE DRAGONFLY CATHETER AND THE GUIDEWIRE TIP WAS OBSERVED TO HAVE SEPARATED. A FLUOROSCOPE WAS USED TO LOCATE THE SEPARATED TIP, IT WAS RETAINED INSIDE THE PROXIMAL SHAFT OF THE GUIDING CATHETER AND INSIDE THE HEMOSTATIC VALVE. THE HEMOSTATIC VALVE WITH THE COIL TIP IN IT, WERE REMOVED. IT IS BELIEVED THAT WHEN THE DRAGONFLY CATHETER WAS REMOVED THE BMW COIL PROLAPSED, AND BECAME ENTANGLED IN THE DRAGONFLY CATHETER. WHEN THE DOCTOR WITHDREW THE DRAGONFLY CATHETER, THE GUIDEWIRE WITHDREW WITH IT, ALL THE WAY INTO THE GUIDE CATHETER. WHEN THE DRAGONFLY CATHETER WAS REMOVED FROM THE HEMOSTATIC VALVE, THE COIL OF THE WIRE SEPARATED AND REMAINED INSIDE THE GUIDE CATHETER. THERE WAS NO CLINICALLY SIGNIFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869544 ↗
• InjuryJun 27, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 190CM HI-TORQUE BALANCED MIDDLE WEIGHT (BMW) UNIVERSAL GUIDE WIRE (GW) WAS BEING PULLED OUT OF THE GUIDING CATHETER, AT AN ANGLE, TO RESHAPE THE TIP, WITH THE GUIDE WIRE INTRODUCER LEFT IN PLACE, AND THE GUIDE WIRE RUBBED UP AGAINST THE GUIDE WIRE INTRODUCER, CAUSING THE GREEN TEFLON COATING TO SHRED OFF THE PROXIMAL TO THE TIP OF THE GUIDE WIRE, OUTSIDE OF THE ANATOMY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17209970 ↗
• InjuryJun 6, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 190CM HI-TORQUE BALANCED MIDDLE WEIGHT (BMW) UNIVERSAL GUIDE WIRE (GW) WAS ADVANCED WITHOUT ISSUE AND A NON-ABBOTT BALLOON WAS USED WITHOUT ISSUE. DURING REMOVAL OF THE BMW GW FROM THE ANATOMY, THE GW TIP BECAME STUCK WITH THE NON-ABBOTT BALLOON AND SEPARATED FROM THE REST OF THE WIRE INSIDE THE DRCA. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL TO ATTEMPT TO SNARE THE GW OUT OF THE ANATOMY, HOWEVER THE SEPARATED TIP WAS NOT ABLE TO BE REMOVED AND REMAINED FREE FLOATING IN THE DRCA. THE PATIENT IS CURRENTLY IN THE HOSPITAL IN STABLE CONDITION BUT WILL BE UNDERGOING SURGERY TO REMOVE THE REMAINING TIP OF THE GUIDE WIRE. AS OF 05/17/2023, THE PATIENT HAS NOT UNDERGONE SURGERY FOR THE REMOVAL OF THE SEPARATED PORTION IN THE ANATOMY. THE PATIENT REMAINS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17072674 ↗