HI-TORQUE BALANCE MIDDLEWEIGHT 1001780Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648013836), received between Jan 20, 2017 and Sep 21, 2026 — classified as 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Separation

  It was reported the procedure was to treat a lesion in the Right Coronary Artery. The Hi-Torque BMW guide wire was advanced into the patient however the radiopaque tip was not visible on fluoro as it had separated. As a result, the procedure could not be completed due to the absence of the radiopaque feature. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841068 ↗
• InjuryDec 18, 2025Difficult to Remove; Material Separation; Stretched; Difficult to Remove; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST OBTUSE MARGINAL (OM1) AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES WITH 85-95% STENOSIS AND CALCIFICATION. LEFT RADIAL ACCESS WAS GAINED AND A 6FR 4.5 GUIDE CATHETER WAS ADVANCED AND SEATED COAXIALLY IN THE OSTIUM OF THE LEFT MAIN (LM). THE BLANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS INSERTED AND ADVANCED WITHOUT DIFFICULTY TO THE DISTAL OM1. A 2.5X15 MM TREK BALLOON WAS USED FOR PRE-DILATATION AND THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ADVANCED. ONE RUN WAS SUCCESSFULLY IMAGED. UPON REMOVAL OF THE DRAGONFLY, THERE WAS A LOT OF RESISTANCE. THE GUIDE WIRE AND DRAGONFLY HAD TO BE REMOVED TOGETHER AS A UNIT. ONCE OUTSIDE THE ANATOMY, THE WIRE WAS FOUND TO BE FRAYED AND COILED LIKE A RIBBON. THE ANATOMY WAS IMAGED AGAIN WITH FLUORO AND A PIECE OF WIRE WAS SEEN IN THE VESSEL. A SNARE WAS UNSUCCESSFUL. A 2.75X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO EMBED THE WIRE PIECE INTO THE VESSEL WALL; HOWEVER, IT COULD NOT CROSS. A 2.5 MM TREK BALLOON WAS ULTIMATELY USED TO TACK THE WIRE PIECE TO THE VESSEL WALL AND A NON-ABBOTT STENT WAS IMPLANTED. A FINAL OCT RUN WAS PERFORMED WITH A NEW DR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23844706 ↗
• MalfunctionJan 16, 2025Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS NOTED THAT IT WAS GREEN TEFLON COATING THAT WAS OBSERVED TO BE SCRATCHED AS THERE IS NO POLYMER COATING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170322 ↗
• MalfunctionNov 13, 2024Product Quality Problem; Difficult to Remove; Product Quality Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE BMW GUIDE WIRE (GW) WAS USED IN THE PROCEDURE WITH A NON-ABBOTT BALLOON DILATATION CATHETER (BDC). HOWEVER, DURING REMOVAL THE BDC AND THE GW BECAME STUCK TOGETHER; THEREFORE, THE GW AND BDC WERE REMOVED AS A SINGLE UNIT. AFTER REMOVAL, THE TRANSITION WELD 30 CM PROXIMAL TO THE GW TIP APPEARED UNUSUAL. 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 20678523 ↗
• InjuryOct 29, 2024Difficult 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 PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN A CORONARY ARTERY. DURING PLACEMENT OF A RADIAL INTRODUCER SHEATH ON THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE, THERE WAS A SEPARATION OF THE GUIDE WIRE. THERE WAS RESISTANCE DURING REMOVAL WITH THE GUIDING CATHETER AND FORCE WAS APPLIED. A 30 CM FRAGMENT REMAINED IN THE ARTERY AND WAS REMOVED WITH A LASSO VIA THE FEMORAL ROUTE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559313 ↗
• MalfunctionOct 24, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WAS ADVANCED AND PLACED; HOWEVER, WHEN ATTEMPTING TO ADVANCE AN UNSPECIFIED BALLOON OVER THE WIRE, THE BALLOON BECAME STUCK AT THE FIRST JUNCTION BEFORE THE DISTAL TIP. THE GUIDE WIRE WAS NOT ABLE TO BE REMOVED INDEPENDENTLY AND BOTH DEVICES WERE REMOVED TOGETHER. A NEW GUIDE WIRE WAS USED TO CONTINUE 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 20525741 ↗
• MalfunctionOct 14, 2024Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BMW GUIDE WIRE WAS ADVANCED HOWEVER BECAME STUCK IN THE LESION AND THE TIP KINKED AND FORMED A KNOT. RESISTANCE WAS MET WITH THE ANATOMY DURING REMOVAL OF THE GUIDE WIRE. THE PROCEDURE CONTINUED USING A WHISPER GUIDE WIRE. 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 20440667 ↗
• MalfunctionNov 21, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING USE, WHEN REMOVING THE HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) GUIDEWIRE, THE GUIDEWIRE LOOPED AROUND THE DRAGONFLY OPTIS IMAGING CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835643 ↗
• InjuryOct 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A BIFURCATION LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE TO HEAVY CALCIFICATION AND >70% STENOSIS. AFTER IMPLANTATION OF THE STENT, THE HI-TORQUE (HT) BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE BECAME JAILED AND WHEN PULLED BACK, THE GUIDE WIRE BECAME TRAPPED. IT WAS NOTED TO BE UNCOILED [UNRAVELED] AND THE TIP SEPARATED INSIDE THE ANATOMY. THE PROCEDURE WAS DONE UNDER FLUOROSCOPY BUT NO CINE IMAGES WERE TAKEN. ATTEMPTED TO SNARE THE SEPARATED TIP BUT WAS UNSUCCESSFUL AND WAS LEFT IN THE BODY. NO FINAL IMAGES WERE TAKEN OF THE MATERIAL LEFT IN THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT AN ADDITIONAL HT BMW GUIDE WIRE WAS RETURNED UNRAVELED AND TIP SEPARATED. THE SEPARATED TIP WAS NOT RETURNED THEREFORE THERE IS A POSSIBILITY THAT THE SEPARATED TIP REMAINS IN THE PATIENT ANATOMY. FOLLOW-UP WITH THE SITE WAS PERFORMED; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.(THEREFORE, THE BMW GUIDEWIRE IS BEING REPORTED UNDER THIS MEDWATCH REPORT.)

  Patient problems: Foreign Body In Patient

  MAUDE report 15523674 ↗
• InjuryMay 27, 2022Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE BRACHIAL VEIN WITH TORTUOSITY. DURING INSERTION OF THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE INTO THE SHEATH, RESISTANCE WAS MET AND FORCE WAS APPLIED. THE GUIDE WIRE SEPARATED AT THE MID CORE. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED PORTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND ACCESS SITES WERE CHANGED. THERE WERE NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521951 ↗
• MalfunctionNov 3, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOSITY DE NOVO LEFT ANTERIOR DESCENDING ARTERY. THE BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE COATING WAS NOTED TO BE PEELING DURING THE PROCEDURE; HOWEVER, IT DID NOT SEPARATE. ANOTHER BMW WAS USED TO SUCCESSFULLY 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 12745859 ↗
• MalfunctionMar 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A NON-CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. THE BALANCE MIDDLEWEIGHT GUIDEWIRE WAS ADVANCED WITHOUT ISSUE. DURING REMOVAL, RESISTANCE WAS FELT WITH THE OPTICAL COHERENCE TOMOGRAPHY (OCT) DRAGONFLY OPSTAR IMAGING CATHETER. THE GUIDEWIRE, OCT CATHETER, AND GUIDE CATHETER ALL HAD TO BE REMOVED TOGETHER AS A SINGLE UNIT. A NEW BMW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE PATIENT WAS MOVING A LOT THROUGHOUT THE ENTIRE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11592371 ↗
• InjuryFeb 17, 2020Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THIS WAS A PERIPHERAL CASE TO TREAT A HEAVY CALCIFIED LESION IN THE SUPERIOR FEMORAL ARTERY. A BMW WIRE WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE GUIDING CATHETER AND THE DISTAL END OF THE WIRE BROKE OFF. TO REMOVE THE WIRE, A SYRINGE WAS ATTACHED TO THE PROXIMAL END OF THE CATHETER AND NEGATIVE PRESSURE WAS APPLIED. BOTH THE WIRE AND THE CATHETER WERE REMOVED AT THE SAME TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716967 ↗
• InjuryJan 27, 2020Difficult 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 PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE NON-TORTUOUS, MODERATELY CALCIFIED, 70% STENOSED DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE, AND THE BMW WAS USED AT THE SAME TIME AS A NON-ABBOTT STENT, A NON-ABBOTT BALLOON, AND ANOTHER BMW GUIDE WIRE. DURING REMOVAL, THE BMW FACED RESISTANCE WITH THE ANATOMY, SO FORCE WAS APPLIED. THE TIP OF THE GUIDE WIRE SEPARATED AND REMAINS FLOATING IN THE PATIENT'S ANATOMY. NO TREATMENT WAS PERFORMED, THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS FINE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9631664 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED THAT DURING UNPACKING, THE TIP OF A 3 CM BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS NOTED TO BE BROKEN. THEREFORE, THE DEVICE WAS REPLACED WITH A NON-ABBOTT GUIDE WIRE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9104390 ↗
• MalfunctionAug 2, 2019Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MARGINAL CIRCUMFLEX CORONARY ARTERY WITH NO REPORTED TORTUOSITY. A HIGH TORQUE BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE LESION WITH NO REPORTED RESISTANCE. FOLLOWING THE DEPLOYMENT OF AN UNSPECIFIED STENT, THE GUIDE WIRE WAS ATTEMPTED TO BE REMOVED; HOWEVER, RESISTANCE WITH THE STENT WAS MET AND THE TIP [COILS] OF THE GUIDE WIRE STRETCHED. THE GUIDE WIRE REPORTEDLY REMAINED IN ONE PIECE AND WAS NOT NOTED TO HAVE UNRAVELED. THE GUIDE WIRE WAS REMOVED INDEPENDENTLY WITH NO REPORTED FORCE 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 Consequences Or Impact To Patient

  MAUDE report 8857833 ↗
• InjuryJul 11, 2019Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Too Soft/Flexible; Entrapment of Device; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Too Soft/Flexible

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES: PER MD'S NOTES: PATIENT HAS A SIGNIFICANT CORONARY ARTERY DISEASE, STATUS POST STRESS TEST WHICH SHOWED SIGNIFICANT ANTERIOR WALL ISCHEMIA. PT WAS BROUGHT IN FOR HEART CATHETERIZATION ABOUT A MONTH AGO, WAS FOUND TO HAVE 3-VESSEL CORONARY DISEASE. PT WAS TURNED DOWN BY SURGERY DUE TO THE FACT PATIENT WAS FRAIL AND HAD POOR TARGETS. PT WAS BROUGHT BACK TODAY FOR A PCI. PER MD'S NOTES: COMPLICATIONS - RETAINED TIP OF THE BMW WIRE AND A SLOW FLOW IN THE DISTAL OBTUSE MARGINAL BRANCH, LIKELY DUE TO THE DISTAL EDGE DISSECTION AT THE STENT LEVEL. ADDITIONAL INFORMATION WAS RECEIVED STATING: REPORTEDLY, THE HEART CATHETERIZATION ABOUT A MONTH AGO THAT WAS ABORTED DUE TO FRAIL AND POOR TARGETS WAS THE PATIENT'S FIRST OPEN HEART SURGERY. THE PATIENT WAS RE-HOSPITALIZED ON (B)(6) 2019 FOR A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS ADVANCED TO THE DISTAL LAD FOLLOWED BY A 2X12MM UNSPECIFIED BALLOON, WHICH WAS USED FOR PRE-DILATATION, AND A 2.5X16MM NON-ABBOTT STENT THAT WAS DEPLOYED. NO ISSUES WERE NOTED.

  Patient problems: Intimal Dissection; Ischemia; Vessel Or Plaque, Device Embedded In

  MAUDE report 8780876 ↗
• InjuryFeb 13, 2018Detachment Of Device Component; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO IMPLANT AN UNSPECIFIED BIVENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BI-V ICD) IN THE MODERATELY TORTUOUS, NON-CALCIFIED, MID CORONARY SINUS BRANCH. A HI-TORQUE (HT) BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS SELECTED FOR THE PROCEDURE. DURING WITHDRAWAL FROM THE ANATOMY, THE HT BMW GUIDE WIRE BECAME ENTANGLED WITH SCREW OF THE UNSPECIFIED SCREW-IN LEFT VENTRICULAR (LV) LEAD AND THE DISTAL TIP OF THE GUIDE WIRE BROKE OFF. IT WAS DETERMINED THAT THE BROKEN TIP WAS TANGLED TO A POINT THAT LEAVING IT ALONE WAS THE SAFEST WAY TO ENSURE IT DID NOT DISLODGE AND EMBOLIZE ELSEWHERE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7266783 ↗
• MalfunctionAug 16, 2017Difficult to Remove

  REPORTEDLY, AN UNKNOWN STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUES; HOWEVER, WHEN ATTEMPTING TO REMOVE THE 014 BMW GUIDE WIRE RESISTANCE REMOVING IT WAS FELT AND IT FELT LIKE IT BECAME STUCK WITH SOMETHING. MORE FORCE THAN USUAL WAS REQUIRED, BUT THE GUIDE WIRE WAS REMOVED. THERE WAS NO NOTED DAMAGE TO THE IMPLANTED STENT OR VESSEL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798115 ↗
• MalfunctionAug 16, 2017Difficult to Remove

  REPORTEDLY, AN UNKNOWN STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUES; HOWEVER, WHEN ATTEMPTING TO REMOVE THE 014 BMW GUIDE WIRE RESISTANCE REMOVING IT WAS FELT AND IT FELT LIKE IT BECAME STUCK WITH SOMETHING. MORE FORCE THAN USUAL WAS REQUIRED, BUT THE GUIDE WIRE WAS REMOVED. THERE WAS NO NOTED DAMAGE TO THE IMPLANTED STENT OR VESSEL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798090 ↗
• MalfunctionAug 16, 2017Difficult to Remove

  REPORTEDLY, AN UNKNOWN STENT WAS DEPLOYED AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUES; HOWEVER, WHEN ATTEMPTING TO REMOVE THE 014 BMW GUIDE WIRE RESISTANCE REMOVING IT WAS FELT AND IT FELT LIKE IT BECAME STUCK WITH SOMETHING. MORE FORCE THAN USUAL WAS REQUIRED, BUT THE GUIDE WIRE WAS REMOVED. THERE WAS NO NOTED DAMAGE TO THE IMPLANTED STENT OR VESSEL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798088 ↗
• MalfunctionMay 22, 2017Break

  IT WAS REPORTED THAT AFTER REMOVING THE DEVICE FROM THE PROTECTIVE HOOP WITHOUT RESISTANCE, THE TIP COILS WERE NOTED UNRAVELED FROM THE CORE; HOWEVER, THEY REMAINED ATTACHED TO THE GUIDEWIRE. THERE WAS NO DEVICE SEPARATION. THE DEVICE WAS DISCARDED AND NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 6583094 ↗
• MalfunctionJan 20, 2017Difficult To Position; Difficult to Remove; Improper or Incorrect Procedure or Method; Physical Property Issue

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. DURING PREP, VISUAL AND TACTILE INSPECTION WERE PERFORMED ON A 014 BALANCE MIDDLEWEIGHT (BMW) 3CM GUIDE WIRE AND A LITTLE STEP WAS NOTED 30 CM FROM THE DISTAL TIP. THE BMW DEVICE WAS ADVANCED INTO THE PATIENT ANATOMY. WHEN ADVANCING A NON-ABBOTT STENT DELIVERY SYSTEM (SDS) OVER THE BMW, THE SDS WAS UNABLE TO BE ADVANCED PAST THE STEP ON THE BMW AND WAS ALSO DIFFICULT TO RETRACT FROM THAT STEP. ALL DEVICES WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. THE BMW GUIDE WIRE WAS REPLACED WITH A NEW UNSPECIFIED GUIDE WIRE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6268423 ↗