HI-TORQUE PILOT 1010480-HRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08717648073854), received between Dec 1, 2016 and Nov 4, 2025 — classified as 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE HI TORQUE PILOT 50 GUIDE WIRE WAS ADVANCED TO THE LESION. THE LESION WAS THEN PRE-DILATED WITH A 2.5X12 MM SEMI-COMPLIANT BALLOON. THE BALLOON WAS ATTEMPTED TO BE REMOVED BUT IT WAS STUCK WITH THE GUIDE WIRE SO THE DEVICES WERE REMOVED TOGETHER. ANOTHER PILOT 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 23469528 ↗
• MalfunctionNov 4, 2025Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE HI TORQUE PILOT GUIDE WIRE COULD NOT CROSS THE LESION DUE TO THE ANATOMY. UPON REMOVAL FROM THE ANATOMY IT WAS NOTED THAT THE POLYMER COATING WAS PEELING. A NON-ABBOTT 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 23467431 ↗
• MalfunctionMay 7, 2025Peeled/Delaminated; Stretched; Peeled/Delaminated; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 80% STENOSED. THE .014 HI-TORQUE PILOT 50 GUIDE WIRE WAS ATTEMPTED TO BE SHAPED PRIOR TO USE, BUT THE TIP COIL BECAME STRETCHED THE BLACK COATING PEELED FROM THE TIP. ANOTHER PILOT 50 GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977691 ↗
• InjuryNov 11, 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 PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A HI-TORQUE PILOT GUIDEWIRE (GW) WAS ADVANCED THROUGH THE LESION AND USED DURING THE PROCEDURE; HOWEVER, DURING RETRACTION, RESISTANCE WITH THE GUIDING CATHETER WAS FELT THEREFORE FORCE WAS APPLIED. IT WAS NOTED THAT THE GUIDING SUPPORT POSITION DEVIATED CAUSING THE GW TO SEPARATE AT THE TIP. THE SEPARATED PIECE WAS RETRIEVED USING OTHER GUIDE WIRES. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652973 ↗
• InjuryAug 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, THE HT PILOT GUIDEWIRE CROSSED THE HEAVILY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY WITHOUT RESISTANCE, BUT PART OF THE SHAFT AND THE RADIOPAQUE TIP OF THE GUIDE WIRE SEPARATED IN THE RCA. THE SEPARATED SEGMENT TRAVELED TO THE DISTAL PORTION OF THE LESION IN THE RCA. ATTEMPTS TO REMOVE THE SEPARATED SEGMENT WERE MADE, BUT NOT SUCCESSFUL. ANOTHER PILOT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN IMPLANTED ONE LONG STENT TO EMBED THE SEPARATED PORTION OF THE WIRE INTO THE VESSEL WALL AND ALSO TO TREAT THE TARGET LESION. THE PATIENT WAS ADMITTED TO THE CARDIAC INTENSIVE CARE UNIT AND WAS DISCHARGED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19942334 ↗
• InjuryAug 8, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE HT PILOT GUIDE WIRE SEPARATED AT THE LOCATION OF INTRAVASCULAR THROMBUS. THE CORRECTED LOT NUMBER FOR THIS DEVICE IS 3110971. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19941505 ↗
• MalfunctionApr 1, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN THE HI TORQUE PILOT GUIDE WIRE WAS OPENED, THE DISTAL PORTION OF THE GUIDE WIRE COATING WAS NOTED TO BE INSUFFICIENT AS IT WAS MISSING FROM THE DEVICE. THEREFORE, THE GUIDE WIRE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. 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 19015725 ↗
• InjuryOct 19, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OCCLUSION OF THE MIDDLE LEFT CIRCUMFLEX (LCX) ARTERY. THE HI-TORQUE (HT) PILOT 50 GUIDE WIRE WAS ADVANCED BUT WITH RESISTANCE WITH THE ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL WITH THE GUIDE CATHETER AND FORCE WAS APPLIED. IT WAS NOTED THAT THE GUIDE WIRE SEPARATED AND ABOUT 45MM AWAY FROM THE TIP COULD NOT BE WITHDRAWN FROM THE ANATOMY DURING REMOVAL. THERE WAS NO ATTEMPT TO RETRIEVE THE SEPARATED PORTION AND WAS LEFT EMBEDDED IN THE VESSEL WALL. THE OPERATION ENDED. THE PATIENT WAS OBSERVED AND COMPLAINED OF NO DISCOMFORT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17966553 ↗
• InjuryMar 30, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  DESCRIBE THE EVENT OR PROBLEM: PATIENT CAME IN AS STEMI (ST-ELEVATION MYOCARDIAL INFARCTION). PATIENT WAS TAKEN TO CCL (CARDIAC CATHETERIZATION LAB). A RADIAL APPROACH WAS USED. TIGER CATHETER WAS USED TO DILATE BOTH THE RIGHT AND LEFT SYSTEMS. A GUIDE WHICH WAS AN ALI, WAS ADVANCED IN A SIMILAR FASHION INTO THE OSTIUM OF THE RCA (RIGHT CORONARY ARTERY) WITH THE HELP OF CROSSFIT WIRE AS WELL AS A PILOT WIRE. THE RCA (RIGHT CORONARY ARTERY) WAS TOTALLY OCCLUDED; IT WAS CANNULATED. A BALLOON WAS ADVANCED FOLLOWED BY ANOTHER BALLOON; MULTIPLE INFLATIONS WERE CARRIED OUT ALONG THE COURSE OF THE TOTAL OCCLUSION. AT THAT TIME, IT WAS NOTED THAT THE TIP OF THE PILOT WIRE WAS BROKEN INSIDE THE RCA. PLAN WAS TO SNARE OUT THE TIP OF THE PILOT WIRE. THE SNARE WAS ADVANCED OVER EACH DELIVERY SYSTEM AND WAS RELEASED INSIDE THE RCA. AFTER MANIPULATION, THE TIP OF THE WIRE WAS SUCKED INTO THE DELIVERY SYSTEM OF THE SNARE AND BOTH THE SNARE AND DELIVERY SYSTEM WERE PULLED OUT PULLING THE TIP OF THE WIRE ALONG WITH THEM. PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATION. NO PATIENT HARM. POST PROCEDURE: PATIENT TRANSFERRED TO ICU PAIN-FREE AND STABLE, PATIENT REMAINED STABLE AND PAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645591 ↗
• MalfunctionMar 13, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE FIRST DIAGONAL CORONARY ARTERY, WITH HEAVY CALCIFICATION, HEAVY TORTUOSITY AND 100% STENOSIS. THE 3CM 014 HI-TORQUE PILOT 50 FAILED TO CROSS THE LESION DUE THE ANATOMY. AFTER BEING REMOVED THE DISTAL TIP OF THE WIRE WAS NOTED WAVY. THERE WAS RESISTANCE MET DURING REMOVAL. ANOTHER NON-ABBOTT 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 16529659 ↗
• MalfunctionJul 12, 2022Difficult 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 THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 014 HI-TORQUE PILOT GUIDE WIRE (GW) WAS ADVANCED BEYOND THE TARGET LESION WITH RESISTANCE NOTED FROM THE LESION. DURING PULLBACK, THE PROXIMAL SHAFT OF THE WIRE KINKED. THE GW WAS REMOVED FROM THE PATIENT WITH RESISTANCE AGAIN FROM THE LESION. THERE WAS NOT ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. THE PROCEDURE WAS CONTINUED WITH ANOTHER PILOT GW. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14990070 ↗
• MalfunctionJun 7, 2022Product 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 100% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 014 HI-TORQUE (HT) PILOT GUIDE WIRE (GW) WAS ADVANCED TO THE TARGET LESION; HOWEVER A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED ON THE GW WITH DIFFICULTY. THE BDC BECAME STUCK 30MM FROM THE PROXIMAL POINT FROM THE DISTAL EDGE OF THE GW. THEREFORE THE GW AND BDC WERE REMOVED TOGETHER FROM THE PATIENT. A BUMP WAS OBSERVED BETWEEN THE CORE AND POLYMER COVER OF THE GW. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER HT PILOT GW AND WITH THE BDC FOR PRE-DILATATION FOLLOWED BY STENT DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621925 ↗
• InjuryFeb 2, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE RIGHT CORONARY ARTERY (RCA) POSTERIOR LEFT VENTRICULAR BRANCH. THE PILOT 50 GUIDE WIRE WAS ADVANCED INTO THE RCA AND INTO THE POSTERIOR BRANCH. A 2.0 X 12 MM TREK DILATATION CATHETER WAS ADVANCED INTO THE RCA, BUT WAS UNABLE TO CROSS TO THE LESION IN THE POSTERIOR BRANCH AND WAS REMOVED WITHOUT DIFFICULTY. A 6FRENCH NON-ABBOTT GUIDE CATHETER EXTENSION WAS ADVANCED INTO THE RCA FOR SUPPORT AND A 1.5 X 20 MM NON-ABBOTT DILATATION CATHETER WAS ADVANCED, BUT WAS UNABLE TO CROSS THE TARGET LESION. THE DILATATION CATHETER AND GUIDE CATHETER EXTENSION WERE PULLED BACK INTO THE GUIDE CATHETER. THE DECISION WAS MADE TO STOP THE PROCEDURE AND ALL DEVICES WERE REMOVED FROM THE ANATOMY. NO DIFFICULTY WAS NOTED DURING REMOVAL; HOWEVER, AT THAT TIME, IT WAS NOTED THAT THE GUIDE WIRE HAD SEPARATED, WITH A PORTION OF THE PILOT GUIDE WIRE REMAINING IN THE ANATOMY. THE SEPARATED SEGMENT REMAINED IN THE POSTERIOR BRANCH, WITH A PORTION SEEN IN THE PROXIMAL RCA. THE PATIENT WAS THEN TRANSFERRED FOR A SURGICAL CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 13430812 ↗
• MalfunctionFeb 1, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT BEFORE USE, THE TOP OF THE OUTER POUCH OF THE DEVICE PACKAGING FOR THE PILOT 50 190 CM WAS NOTED TO BE UNSEALED/OPENED. THE DEVICE WAS NOT 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 13419761 ↗
• MalfunctionJul 27, 2021Break; Difficult to Remove; Stretched; Break; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE PILOT 50 GUIDE WIRE WAS USED AND WHEN THE PROCEDURE WAS COMPLETED, THE GUIDE WIRE WAS REMOVED. RESISTANCE WAS NOTED BUT IT COULD NOT BE DETERMINED IF IT WAS WITH THE ANATOMY OR THE GUIDING CATHETER. THE COILS HAD STRETCHED AWAY FROM THE CORE OF THE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. PHOTOS PROVIDED SHOW THE COILS ARE STRETCHED OUT, BUT THE TIP OF THE GUIDE WIRE IS INTACT. COMMUNICATION WITH THE ACCOUNT CONFIRMED NO PORTION REMAINED IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226534 ↗
• MalfunctionApr 28, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS 80% STENOSED. DURING ADVANCEMENT, WITHOUT RESISTANCE, OF THE 014 HI-TORQUE PILOT 50 GUIDE WIRE, IT APPEARED TO BE PEELING SO IT WAS REMOVED RAPIDLY, WITHOUT RESISTANCE. IT WAS CONFIRMED THAT THERE WERE NO PEELINGS LEFT IN THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER PILOT 50 WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739677 ↗
• MalfunctionApr 5, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX (CX) ARTERY THAT WAS MODERATELY CALCIFIED, HEAVILY TORTUOUS AND 99% STENOSED. THE PILOT GUIDE WIRE FAILED TO CROSS THE LESION; THUS, DID NOT ADVANCE TO THE DESIRED LOCATION. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11617030 ↗
• MalfunctionSep 13, 2019Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT A HI TORQUE PILOT 50 GUIDE WIRE FELT RESISTANCE WITH AN UNSPECIFIED INTRAVASCULAR ULTRASOUND CATHETER, AND THE GUIDE WIRE FELT STICKY. RESISTANCE WAS FELT REMOVING THE GUIDE WIRE FROM THE CATHETER. HOWEVER, THE DEVICES WERE ABLE TO BE REMOVED SEPARATELY WITHOUT OTHER ISSUES. A NEW UNSPECIFIED 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 Consequences Or Impact To Patient

  MAUDE report 9036656 ↗
• MalfunctionMay 20, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN ATTEMPTING TO BACK LOAD AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER ONTO THE 014 HI-TORQUE PILOT GUIDE WIRE AND RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE IVUS CATHETER FROM THE GUIDE WIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT, AND A NEW 014 HI-TORQUE PILOT GUIDE WIRE WAS ADVANCED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626171 ↗
• MalfunctionAug 10, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AT THE END OF PROCEDURE, A NEW HT PILOT 50 GUIDE WIRE WAS ADVANCED TO THE LESION WITHOUT ANY ISSUES NOTED. A NON-ABBOTT INTRAVASCULAR ULTRASOUND (IVUS) DEVICE MADE ONE SUCCESSFUL PASS OVER THE HT PILOT 50 GUIDE WIRE. DURING THE SECOND PASS, RESISTANCE WAS FELT BETWEEN THE HT PILOT 50 GUIDE WIRE AND THE IVUS DURING ADVANCEMENT. THE IVUS HAD TO BE PULLED USING FORCE TO BE REMOVED FROM THE GUIDE WIRE DURING WITHDRAWAL. BOTH DEVICES WERE REMOVED INDIVIDUALLY FROM THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773949 ↗
• InjuryJun 11, 2018Detachment Of Device Component; Difficult To Position

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE RE-STENOSED STENT IN THE PROXIMAL OBTUSE MARGINAL, THE HI-TORQUE PILOT 50 GUIDE WIRE MET RESISTANCE DURING ADVANCING IN THE NON-ABBOTT GUIDELINER. WHILE ATTEMPTING TO REMOVE THE PILOT 50 THE RADIOPAQUE TIP BECAME SEPARATED FROM THE WIRE; REMAINING IN THE AORTA. A SNARE DEVICE WAS USED TO RETRIEVE THE TIP FRAGMENT FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589860 ↗
• InjuryMay 11, 2018Failure to Advance; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE WAS PLACED IN THE LEFT ANTERIOR DESCENDING (LAD). USING A BUDDY WIRE TECHNIQUE, A HI-TORQUE PILOT GUIDE WIRE WAS ADVANCED TO THE BMW WITHOUT ISSUE, HOWEVER, THE DEVICE FAILED TO CROSS THE MODERATELY CALCIFIED LESION AS A PERFORATION OCCURRED AT THE HT PILOT LAD SITE. THE DEVICE WAS REMOVED WITHOUT REPORTED ISSUE AND BALLOON ANGIOPLASTY WAS PERFORMED FOR 2 MINUTES AS TREATMENT. THE PERFORATION WAS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 7507724 ↗
• InjuryFeb 5, 2018Failure to Advance

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTION TO TREAT A CHRONIC TOTAL OCCLUSION IN THE DISTAL RIGHT CORONARY ARTERY, THE PILOT GUIDE WIRE WAS ADVANCED TO THE DISTAL POSTERIOR DESCENDING CORONARY ARTERY WHEN A PERFORATION OCCURRED. THE PERFORATION WAS TREATED WITH A COLLAGEN PLUG. THE PATIENT IS REPORTEDLY WELL AND THE EVENT RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS ISSUE.

  Patient problems: Perforation

  MAUDE report 7241411 ↗
• MalfunctionSep 1, 2017Detachment Of Device Component; Failure to Advance; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED OBTUSE MARGINAL AND RIGHT CORONARY ARTERY. THE PATIENT PRESENTED WITH A ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A PILOT 50 GUIDE WIRE WAS BEING USED WHEN THE GUIDE WIRE MET RESISTANCE DURING ADVANCING AND FELT WEIRD, SO IT WAS REMOVED FROM THE ANATOMY. THE PHYSICIAN FELT THAT THE GUIDE WIRE HAD SEPARATED; ALTHOUGH WHEN REMOVED FROM THE ANATOMY IT APPEARED TO BE IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW GUIDE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6840083 ↗
• MalfunctionMar 9, 2017Detachment Of Device Component; Difficult To Position; Difficult to Remove

  USER FACILITY MEDWATCH REPORT, MW5067496, RECEIVED THAT STATES THE FOLLOWING:WHILE USING FLEXTONE 4.0X15 IN RCA THRU ALR 1.26 FT MEDTRONIC- WOULDN'T CROSS AND PILOT 50 190 GUIDE USED AS BODDY - WOULDN'T PASS- PLATINUM TIP OF WIRE WAS STRIPPED FROM WIRE- X-RAY SHOWED TIP INGUIDE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2016, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT CORONARY ARTERY (RCA), HEAVILY CALCIFIED, 99% RE-STENOSED LESION CONTAINING PREVIOUS, UNSPECIFIED STENTS. A PILOT GUIDEWIRE ADVANCED TO THE RCA LESION WITHOUT ISSUE. FOLLOWING A NON-ABBOTT CUTTING BALLOON ATTEMPTED TO ADVANCE ON THE PILOT GUIDEWIRE MULTIPLE TIMES WITHOUT SUCCESS. DURING PILOT GUIDEWIRE REMOVAL, RESISTANCE WAS NOTED WITH THE CUTTING BALLOON AND THE TIP SEPARATED AND REMAINED INSIDE THE GUIDE CATHETER. ALL WAS REMOVED WITHOUT ISSUE. NOTHING WAS LEFT IN THE PATIENTS ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6393684 ↗