COUGAR® XT CGRXT190HS (UDI 00643169453326)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169453326), received between Jun 15, 2017 and Feb 17, 2023 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 17, 2023Device Contamination with Chemical or Other Material; Material Deformation; Device Contamination with Chemical or Other Material; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO COUGAR XT 0.014¿ GUIDEWIRES TO TREAT A LESION. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED TO THE DEVICES WHEN BEING REMOVED FROM THE PACKAGING PER THE IFU. THE DEVICES WERE NOT INSPECTED. THERE WAS NO DEFORMATION TO THE TIP OF THE COUGAR DEVICES. THERE WAS NO DAMAGE NOTED TO ANY OTHER PART OF THE DEVICES. THE NEW COUGAR DEVICE WAS PREPPED AS PER THE IFU PRIOR TO USE. THE BALLOON WAS PREPPED AS PER THE IFU PRIOR TO USE. THE TIP WAS NOT FORMED BY THE HEALTH CARE PROFESSIONAL. IT WAS REPORTED THAT THE DEVICES WERE NOT SMOOTH, THERE WAS AN ISSUE WITH THE STRUCTURE ON THE TIP SIDE OF THE DEVICES. IT WAS STATED THAT THE DEVICE DID NOT WORK PROPERLY DURING THE PROCEDURE AS THE WIRE WAS STUCK UP IN THE BALLOON. IT WAS ALSO NOTED THAT THE COUGAR DEVICES WERE ENTRAPPED IN THE BALLOON AND THAT THE COUGAR GUIDEWIRES CAUSED DAMAGE TO THE BALLOON DEVICES. BOTH COUGAR DEVICES WERE USED WITH TWO SEPARATE BALLOONS. THE DEVICES WERE USED IN THE PATIENT. THE DEVICES CAUSED NO DAMAGE TO THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395973 ↗
• MalfunctionAug 11, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT, ONE COUGAR GUIDEWIRE AND ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A NON-TORTUOUS LESION IN THE PROXIMAL LM ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE COUGAR AND THE LAUNCHER WERE PREPPED PER IFU WITH NO ISSUES. THE COUGAR WIRE TIP WAS FORMED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE RESOLUTE ONYX AND LAUNCHER DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE COUGAR DEVICE DID PASS THROUGH A DEPLOYED RESOLUTE ONYX. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE COUGAR DEVICE WAS NOT USED WITH OTHER DEVICES PRIOR TO DIFFICULTIES OCCURRING. IT WAS REPORTED THAT A LAUNCHER WAS USED WITH A NON-MEDTRONIC GUIDEWIRE TO DELIVER THE RESOLUTE ONYX TO THE LEFT MAIN. AFTER THE PROCEDURE WAS COMPLETED AND WIRE WAS REMOVED ANOTHER ANGIOGRAM WAS TAKEN. A NON-MEDTRONIC OCT DEVICE WAS USED TO IMAGE THE STENT. USING THE LAUNCHER GUIDE CATHETER, THE COUGAR WIRE WAS USED TO CROSS THE NEWLY IMPLANTED STENT. NO ISSUES WERE NOTED. THE DEPLOYED RESOLUTE ONYX WAS CROSSED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306717 ↗
• InjuryJun 8, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ONE COUGAR GUIDE WIRE WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING REMOVAL OF THE DEVICE AND DEVICE DETACHMENT OCCURRED. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain; Pseudoaneurysm; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 11957677 ↗
• InjuryMar 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDEWIRE TO TREAT A MILDLY CALCIFIED LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE WAS NOT INSPECTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE TIP OF THE WIRE DETACHED DURING DELIVERY TO THE LESION. IT WAS STATED THAT IT WAS NOT POSSIBLE TO REMOVE THE DETACHED TIP AS A SNARE WAS NOT AVAILABLE. A STENT WAS IMPLANTED TO BLOCK THE DETACHED TIP. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11420629 ↗
• InjuryMar 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDEWIRE TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE TIP OF THE WIRE DETACHED DURING DELIVERY TO THE LESION. IT WAS STATED THAT ONE PART OF THE DEVICE WAS RETRIEVED USING A SNARE AND THE OTHER PART OF THE DEVICE WAS BLOCKED BY IMPLANTING A STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11420147 ↗
• InjuryFeb 17, 2021Material Split, Cut or Torn

  WHILE PERFORMING AN ACUTE MI INTERVENTION, ONCE THE STENT WAS PLACED UPON WIRE REMOVAL IT SEEMED TO HAVE CAUGHT ON THE STENT STRUT AND SHEERED WIRE APART. A SECOND STENT WAS PLACED TO OPPOSE WIRE TO VESSEL WALL. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343683 ↗
• MalfunctionOct 27, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDEWIRE TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PREDILATED USING A NON MEDTRONIC BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE WIRE BECAME UNRAVELED IN THE PATIENT WHEN NOTICED IT WAS ABLE TO BE PULLED OUT COMPLETELY. A DEVICE DETACHMENT WAS NOTED. OCT IMAGING WAS USED. THE ISSUE WAS NOTICED WHEN A STENT WAS BEING ADVANCED TO THE LESION. EVERYTHING WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10741994 ↗
• InjuryOct 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE COUGAR GUIDE WIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A NON-TORTUOUS LESION IN THE PROXIMAL LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED TO THE DEVICE DURING REMOVAL FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. AN EBU 4.5 GUIDE CATHETER WAS ALSO USED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE WIRE TIP DETACHED WHILE IN THE PATIENT. AFTER STENTING THE LAD, THE PHYSICIAN WENT TO WITHDRAW THE WIRE AND NOTICED THAT THE TIP HAD BROKEN OFF. THE PHYSICIAN THEN RE-WIRED THE VESSEL AND JAILED THE DETACHED SEGMENT AGAINST VESSEL WALL IN THE LAD WITH ANOTHER STENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Insufficient Information

  MAUDE report 10703700 ↗
• MalfunctionFeb 13, 2020Material Deformation; Material Deformation

  A COUGAR GUIDEWIRE DEVICE WAS BEING USED TO TREAT A MAMMARY GRAFT IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED WITH 95% STENOSIS. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER THE IFU. THE DEVICE WAS INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION AND DELIVERY. IT WAS REPORTED THAT THE LAD WAS WIRED THROUGH A LIMA GRAFT WITH THE COUGAR XT 190CM WIRE INSIDE A NON MEDTRONIC MICROCATHETER. RESISTANCE WAS FELT WHEN WIRING THE VESSEL AND IT WAS FELT THAT THE WIRE WAS STARTING TO UNCOIL AT THAT POINT. AS THE COUGAR WIRE WAS BEING REMOVED RESISTANCE WAS ENCOUNTERED. THE WIRE WAS REMOVED SAFELY FROM THE PATIENT HOWEVER IT WAS OBSERVED THAT THE WIRE STARTED TO UNCOIL. THE UNCOILING OCCURRED WHEN THE DEVICE WAS IN THE PATIENT. THE COILS BECAME STRETCHED. THERE WAS NO FRACTURE OF THE COIL. THERE WAS NOT A COMPLETE DETACHMENT OF THE WIRE. NO PATIENT INJURY WA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9705038 ↗
• MalfunctionJan 30, 2020Material Deformation; Material Deformation

  ONE STR HYDRO MODEL COUGAR GUIDE WIRE WAS USED DURING A PROCEDURE TO TREAT A LESION IN A MODERATELY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION HAD 50-75% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUE NOTED WHEN THE DEVICE WAS REMOVED FROM PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE DILATED WITH A 2.25 EUPHORA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. ONE 2.25 X 26 RESOLUTE ONYX DRUG ELUTING STENT WAS DEPLOYED AT 14 ATM FOR 15 SEC. THE RESOLUTE ONYX WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PREFORMED WITH NO ISSUES NOTED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE STENT BALLOON, RESISTANCE WAS ENCOUNTERED. THE STENT BALLOON WAS THEN TAKEN BACK UP TO 3 ATM AND DIALED BACK DOWN AGAIN, BUT STILL COULD NOT BE REMOVED. THE COUGAR WIRE AND THE ONYX STENT BALLOON WERE REMOVED TOGETHER. WHEN OUT SIDE OF THE PATIENT BODY FORCE WAS USED TO REMOVED THE WIRE FROM THE STENT BALLOON AND A KINK WAS FELT IN THE WIRE. PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646441 ↗
• MalfunctionJan 8, 2020Material Deformation; Material Deformation

  A COUGAR GUIDE WIRE WAS USED DURING A PROCEDURE TO TREAT A SEVERELY TORTUOUS, NON CALCIFIED LESION EXHIBITING 100% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE PATIENT WAS STEMI AND THE PHYSICIAN FELT THE WIRE WASN'T STEERING WELL AND WHEN THE DEVICE WAS REMOVED THE WIRE WAS UNRAVELED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564105 ↗
• MalfunctionJan 23, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A COUGAR GUIDEWIRE WAS ATTEMPTED TO BE USED. IT IS REPORTED THAT A PORTION OF THE GUIDEWIRE DETACHED IN VIVO. THE DETACHMENT OCCURRED WITHIN A GUIDE CATHETER. THE COUGAR GUIDEWIRE WAS REMOVED TOGETHER WITH THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270381 ↗
• InjuryJan 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A COUGAR WIRE WAS ATTEMPTED TO BE USED TO TREAT A CALCIFIED LESION WITH 90% STENOSIS IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE TIP OF THE DEVICE DETACHED AFTER PCI. THE PATIENT WENT TO SURGERY TO REMOVE THE DETACHED PORTION. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8216554 ↗
• InjurySep 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A COUGAR GUIDEWIRE WAS INTENDED TO BE USED DURING A PROCEDURE FOR A LESION LOCATED IN THE MID LAD, EXHIBITING NO TORTUOSITY, MILD CALCIFICATION AND 100% STENOSIS. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING DEVICE FROM PACKAGING AS PER IFU. DEVICE WAS INSPECTED AND PREPPED PER IFU WITHOUT ISSUE. DEVICE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS FELT AND EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE DEVICE DETACHED IN VIVO. THE VERY TIP OF THE WIRE CAME OFF AND WAS TRAPPED BETWEEN THE VESSEL WALL AND STENT. NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7901566 ↗
• InjuryMar 29, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN INTENDED TO USE A COUGAR XT 0.014" GUIDE WIRE TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED DISTAL LESION IN THE CIRCUMFLEX. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THERE WAS NO RESISTANCE MOVING THE WIRE FORWARD. EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN WAS WORKING FROM THE RIGHT RADIAL ARTERY AND WAS USING A MEDTRONIC EBU GUIDE CATHETER. THE DISTAL WIRE BECAME FOLDED UP ON ITSELF IN THE DISTAL VESSEL. IT IS REPORTED THAT DURING REMOVAL THE WIRE BROKE, AND A PORTION OF THE DEVICE DETACHED AND APPEARED TRAPPED UNDER THE STENT OR IN THE CALCIUM. NO INTERVENTION WAS PERFORMED, THE DEVICE PORTION REMAINS TRAPPED IN THE PATIENT. NO FURTHER PATIENT INJURY IS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7380612 ↗
• InjuryOct 3, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A CARDIAC CATHETERIZATION INTERVENTION OF THE RIGHT CORONARY ARTERY (RCA), THE DISTAL PORTION OF THE COUGAR GUIDE WIRE BEING USED SHEARED OFF INTO THE RCA. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE PORTION OF THE GUIDE WIRE THAT BECAME LODGED IN THE VESSEL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6910468 ↗
• MalfunctionAug 17, 2017Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN WAS USING A COUGAR WIRE WHEN PLACING LV-LEADS IN A LESION SITUATED IN THE MID/ DISTAL LM. NO DAMAGE WAS NOTED TO THE COUGAR WIRE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE WIRE FROM THE HOOP. THE WIRE WAS INSPECTED AND PREPPED PER IFU. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. NO PREVIOUSLY STENT WAS PRESENT IN THE LESION. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND NO FORCE WAS APPLIED. IT WAS SEEN DURING RADIOGRAPHY THAT THE WIRE BECAME DAMAGED DURING PLACEMENT. THERE WAS NO DAMAGE TO THE LEAD. THE SAME LEAD WAS USED WITH A DIFFERENT GUIDE WIRE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799848 ↗
• InjuryJun 28, 2017Detachment of Device or Device Component; Material Distortion; Detachment of Device or Device Component; Material Distortion

  NO DAMAGE WAS NOTED TO THE COUGAR GUIDE WIRE (GW) PACKAGING. NO ISSUES WERE NOTED REMOVING THE WIRE FROM THE HOOP. THE WIRE WAS INSPECTED AND PREPPED PER IFU. THE TIP WAS FORMED BY THE PHYSICIAN. THE INTENDED LESION WAS IN THE PROXIMAL LAD AND EXHIBITED MILD TORTUOSITY, MODERATE CALCIFICATION AND WAS 100% OCCLUDED. THE LESION WAS PRE-DILATED. THE GUIDEWIRE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE THROUGH THE STENT DELIVERY SYSTEM, NO FORCE WAS APPLIED. THE GUIDEWIRE WAS ADVANCED THROUGH THE DILATED LESION, A STENT WAS DEPLOYED AND WHEN THE BALLOON WAS DEFLATED AND PULLED BACK, THE WIRE WAS PULLED BACK AND NOTED TO BE UNCOILED. NO RESISTANCE WAS ENCOUNTERED WHEN RETRACTING THE STENT DELIVERY SYSTEM (SDS) OVER THE WIRE. THE CORE OF THE WIRE WAS KINKED AND BROKEN AND THE WIRE WAS UNCOILED PROXIMAL TO THE RADIOPAQUE PART, SITUATED AT THE APPLICABLE PART OF THE LAD. A BALLOON WAS ADVANCED OVER THE VERY THIN UNCOILED WIRE DOWN TO THE RADIOPAQUE PART, IT WAS KEPT TAUT AND THE WIRE WAS PULLED BACK IN ONE PIECE. THE WIRE DID NOT GET CAUGHT ON THE DEPLOYED STENT. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6672617 ↗
• MalfunctionJun 15, 2017Material Distortion; Material Distortion

  THE PHYSICIAN INTENDED TO USE A COUGAR GUIDE WIRE DURING A PROCEDURE. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE WIRE FROM THE HOOP. THE WIRE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. DAMAGE WAS NOTED TO THE WIRE ON REMOVAL FROM THE PATIENT. ANALYSIS OF THE RETURNED WIRE IDENTIFIED STRETCHED COILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6642795 ↗