HI-TORQUE PILOT 1010480-HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648073861), received between Sep 4, 2018 and May 5, 2025 — classified as 4 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGING OF THE PILOT GUIDE WIRE, THE PHYSICIAN WIPED THE WIRE AND SOME KIND OF MATERIAL WAS NOTED ON THEIR GLOVES. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER PILOT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960514 ↗
• 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 LEFT ANTERIOR DESCENDING ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. AFTER CROSSING THE MID LESION WITH THE HI-TORQUE PILOT GUIDE WIRE, THE 3.5X12MM NC TRAVELER WAS USED FOR PRE-DILATATION. RESISTANCE WAS MET DURING ADVANCEMENT AND REMOVAL ON THE GUIDE WIRE. AFTER STENT DEPLOYMENT, A 4.0X8MM 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. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801532 ↗
• MalfunctionMar 4, 2022Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS VESSEL IN THE LEFT CORONARY ARTERY (LCA). THE HI-TORQUE (HT) PILOT AND (2) BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRES WERE ATTEMPTED TO BE USED, HOWEVER, STENTS AND BALLOONS WERE DIFFICULT TO ADVANCE OVER THE GUIDE WIRES. THE STENT DELIVERY SYSTEM (SDS) AND BALLOON DILATATION CATHETER (BDC) WERE PREPARED AND FLUSHED PRIOR TO USE. IT WAS ALSO NOTED THAT A THIRD BMW GUIDE WIRE WAS INVOLVED IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS SHOWED THAT THE PROXIMAL END OF THE POLYMER COATING WAS SCRATCHED AND TORN OFF FOR APPROXIMATELY 1.5-MM AND WAS NOT RETURNED. COMMUNICATION WITH THE ACCOUNT CONFIRMED THERE WAS NO MATERIAL LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666817 ↗
• InjuryMar 26, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE PILOT GUIDE WIRE WAS ADVANCED WITHOUT DIFFICULTY TO THE CALCIFIED AND TORTUOUS LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY IN THE PATIENT WITH AN ACUTE MYOCARDIAL INFARCTION. THE PHYSICIAN COMMENTED THAT THE GUIDE WIRE WAS VERY LUBRICIOUS AND IT WAS NECESSARY TO HOLD IT. MULTIPLE BALLOONS WERE USED TO PREDILATE THE LESION, BUT A STENT WAS UNABLE TO REACH THE LESION DUE TO THE VESSEL CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY ONLY, BUT A VESSEL PERFORATION OCCURRED. IT IS SUSPECTED THAT THE PILOT GUIDE WIRE IS RELATED TO THE PERFORATION. NO TREATMENT WAS REQUIRED FOR THE PERFORATION. THE PATIENT IS IN STABLE CONDITION. THERE WAS NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 9884068 ↗
• InjuryMar 11, 2020Material Separation; Material Too Soft/Flexible; Material Separation; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION VIA THE RIGHT RADIAL ARTERY ACCESS. THE PILOT 50 GUIDEWIRE LOOPED. THE GUIDE WIRE SEPARATED 3CM FROM THE TIP DURING RETRIEVAL. THE DISTAL PORTION WAS LEFT IN THE ARM, APPROXIMATELY 10CM FROM THE WRIST. MEDICATION WAS GIVEN AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9818349 ↗
• InjuryJan 9, 2020Difficult 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 PROVIDED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE HI TORQUE PILOT 50 GUIDE WIRE FACED RESISTANCE DURING ADVANCEMENT WITH AN UNSPECIFIED GUIDING CATHETER. THEN THE GUIDE WIRE FACED RESISTANCE DURING REMOVAL WITH THE SAME GUIDING CATHETER, SO FORCE WAS APPLIED. THE TIP SEPARATED, SO A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED TIP. A NEW HI TORQUE PILOT 50 GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571862 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 2 HOURS POST A CORONARIOGRAPHY, THE PATIENT EXPERIENCED TWO SYNCOPAL EPISODES AND WAS HYPOTENSIVE. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) NOTED A SEVERE PERICARDIAL EFFUSION WITH CARDIAC TAMPONADE. FROM THE PILOT 50 GUIDE WIRE. SURGICAL INTERVENTION WAS PERFORMED AND THE PATIENT WAS TREATED WITH 2 UNITS PACKED RED BLOOD CELLS, WITH A GOOD PATIENT OUTCOME. ON (B)(6) 2019, THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Syncope

  MAUDE report 9522112 ↗
• MalfunctionDec 23, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING ARTERY. THE PILOT 50 GUIDE WIRE MET RESISTANCE WITH AN UNSPECIFIED BALLOON CATHETER. RESISTANCE WAS ALSO NOTED DURING RETRIEVAL AND FORCE WAS APPLIED. ALTHOUGH IT WAS REPORTED THAT DURING USE, THE POLYMER COATING PEELED OFF OF THE GUIDE WIRE AND WAS RETRIEVED WITH THE BALLOON CATHETER AS A SINGLE UNIT, THE IMAGE PROVIDED SHOWS THE SEPARATED [POLYMER COATING] IS A CLEAR TUBING WHICH IS NOT A COMPONENT OF THE PILOT 50 GUIDE WIRE. 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 9511241 ↗
• MalfunctionJun 28, 2019Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CONCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH MODERATE TORTUOSITY AND 70% STENOSIS. A 014 HI-TORQUE PILOT 50 GUIDE WIRE LOST LUBRICITY AND STUCK TO AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC). THE GUIDE WIRE AND BDC WERE REMOVED TOGETHER AS A SINGLE UNIT. A BALANCE MIDDLE WEIGHT GUIDE WIRE WAS ADVANCED WITH THE SAME BDC TO SUCCESSFULLY COMPLETE LESION ANGIOPLASTY AND AN UNSPECIFIED XIENCE ALPINE STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746176 ↗
• MalfunctionJun 6, 2019Difficult to Remove; Material Too Rigid or Stiff; Difficult to Remove; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY THAT WAS 60% STENOSED. DURING THE PROCEDURE AND USE OF A 014 WHISPER GUIDE WIRE, THE LUBRICITY OF THE GUIDE WIRE WAS LOST AND BEGAN TO STICK TO THE UNSPECIFIED BALLOON THAT WAS USED. RESISTANCE WAS REPORTED DURING REMOVAL WITH AN UNSPECIFIED BALLOON CATHETER. THE SAME OCCURRED FOR A HI-TORQUE PILOT GW. A 014 ASAHI SOFT 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 8676634 ↗
• MalfunctionMay 14, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 60% STENOSED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. A 014 HI-TORQUE PILOT GUIDE WIRE WAS ADVANCED IN A NON-ABBOTT BALLOON CATHETER; HOWEVER, THE GUIDE WIRE WAS UNABLE TO BE REMOVED FROM THE BALLOON CATHETER DUE TO RESISTANCE. BOTH THE BALLOON CATHETER AND GUIDE WIRE HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW WHISPER MS GUIDE WIRE AND BALLOON ANGIOPLASTY. 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 8609936 ↗
• MalfunctionJan 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT REGARDING HI-TORQUE (HT) PILOT 50 GUIDE WIRES STICKING TO BALLOON CATHETERS DURING ADVANCEMENT, AND HAVING TO REMOVE THE GUIDE WIRE WITH THE BALLOON CATHETER AS A SINGLE UNIT. A NEW PILOT GUIDE WIRE AND UNSPECIFIED BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAYS IN ANY OF THE PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219219 ↗
• MalfunctionJan 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT REGARDING HI-TORQUE (HT) PILOT 50 GUIDE WIRES STICKING TO BALLOON CATHETERS DURING ADVANCEMENT, AND HAVING TO REMOVE THE GUIDE WIRE WITH THE BALLOON CATHETER AS A SINGLE UNIT. A NEW PILOT GUIDE WIRE AND UNSPECIFIED BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAYS IN ANY OF THE PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219186 ↗
• MalfunctionJan 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT REGARDING HI-TORQUE (HT) PILOT 50 GUIDE WIRES STICKING TO BALLOON CATHETERS DURING ADVANCEMENT, AND HAVING TO REMOVE THE GUIDE WIRE WITH THE BALLOON CATHETER AS A SINGLE UNIT. A NEW PILOT GUIDE WIRE AND UNSPECIFIED BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAYS IN ANY OF THE PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219164 ↗
• MalfunctionJan 4, 2019Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PHYSICIAN MADE A GENERAL COMMENT REGARDING HI-TORQUE (HT) PILOT 50 GUIDE WIRES STICKING TO BALLOON CATHETERS DURING ADVANCEMENT, AND HAVING TO REMOVE THE GUIDE WIRE WITH THE BALLOON CATHETER AS A SINGLE UNIT. A NEW PILOT GUIDE WIRE AND UNSPECIFIED BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAYS IN ANY OF THE PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8219091 ↗
• MalfunctionDec 3, 2018Product 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 DE NOVO LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 80% STENOSED. THE LESION WAS CROSSED WITH A HI-TORQUE PILOT 50 GUIDE WIRE. THE MINI TREK RX 2.0 X12 MM BALLOON DILATATION CATHETER (BDC) CROSSED AND THE LESION WAS PRE-DILATED, HOWEVER, DURING WITHDRAWAL OF THE BDC, RESISTANCE WAS MET WITH THE GUIDE WIRE AND IT WAS REMOVED WITH DIFFICULTY. A NON-SPECIFIED STENT DELIVERY SYSTEM WAS ADVANCED BUT IT COULD NOT CROSS LESION BECAUSE OF RESISTANCE WITH THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND THE COATING OF THE PILOT 50 WAS FOUND TO HAVE A STICKY FEELING. THERE WAS A DELAY IN THE PROCEDURE, HOWEVER, IT WAS NOT CLINICALLY SIGNIFICANT AS IT WAS STATED THERE WERE NO PATIENT EFFECTS. NO MEDICATION WAS GIVEN TO THE PATIENT DUE TO AN ISSUE WITH THE USE OF THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126562 ↗
• MalfunctionNov 28, 2018Product Quality Problem; Difficult to Remove; Difficult to Advance; Product Quality Problem; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD TORTUOSITY, MILD CALCIFICATION AND 80% STENOSIS. FOLLOWING ADVANCEMENT OF A HI-TORQUE PILOT 50 GUIDE WIRE TO THE LESION, AN UNSPECIFIED BALLOON DILATION CATHETER (BDC) WAS ADVANCED FOR PRE-DILATATION. ON REMOVAL OF THE BDC, RESISTANCE WITH THE GUIDE WIRE WAS MET. AN UNSPECIFIED STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED OVER THE SAME GUIDE WIRE; HOWEVER, RESISTANCE WITH THE WIRE WAS MET AND THE SDS COULD NOT CROSS THE LESION. RESISTANCE WAS ALSO MET ON REMOVAL OF THE SDS, THEREFORE, THE GUIDE WIRE AND SDS WERE REMOVED TOGETHER AS A SINGLE UNIT. FOLLOWING REMOVAL, THE COATING OF THE GUIDE WIRE WAS NOTED TO FEEL STICKY. A NEW UNSPECIFIED GUIDE WIRE WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. WHILE A DELAY IN THE PROCEDURE OCCURRED, THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8111507 ↗
• MalfunctionSep 12, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH 95% STENOSIS. A 014 HI-TORQUE PILOT GUIDEWIRE WAS ADVANCED TO THE LESION. AN UNSPECIFIED 2.0X15 MM SEMI COMPLIANT BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION WITH RESISTANCE ON THE GUIDEWIRE. AN ATTEMPT TO MOVE THE GUIDEWIRE WHILE THE BALLOON WAS INFLATED WAS MADE. THE BDC WAS REMOVED INDEPENDENTLY WITH RESISTANCE FROM THE GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY DEPLOYING AN UNSPECIFIED 3.5X24 MM DRUG ELUTING STENT USING THE SAME GUIDEWIRE. THERE WERE NO PROBLEMS ADVANCING THE STENT DELIVERY SYSTEM OVER THE GUIDEWIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7870221 ↗
• MalfunctionSep 4, 2018Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 95% STENOSED AND DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY. A 014 HI-TORQUE PILOT GUIDE WIRE WAS ADVANCED TO THE LESION AND A 2.0X15MM UNSPECIFIED BALLOON DILATATION CATHETER (BDC) WAS ADVANCED; HOWEVER, RESISTANCE WAS MET AND THE BDC BECAME STUCK ON THE GUIDE WIRE AND COULD NOT BE REMOVED. THE GUIDE WIRE AND BDC WERE REMOVED AS A SINGLE UNIT. THE LESION WAS PRE-DILATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A 3.0X32MM UNSPECIFIED DRUG ELUTING STENT. 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 7843442 ↗