COUGAR® XT CGRXT190HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169452824), received between Aug 17, 2017 and Apr 16, 2021 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 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 COUGAR GUIDEWIRE TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH NO STENOSIS LOCATED IN THE DISTAL CORONARY SINUS VEIN. THE DEVICE WAS BEING USED TO DELIVER AN LV LEAD IN A BIV IMPLANT. 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 NOT FORMED BY THE PHYSICIAN. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT THE DISTAL RADIOPAQUE DETACHED DURING REMOVAL OF THE DEVICE. THE DEVICE WAS LEFT IN THE PATIENT AND NO INTERVENTION WAS CARRIED OUT. IT WAS ALSO REPORTED THAT STRETCHED COILS WERE NOTED DURING REMOVAL AND THE COILS WERE UNRAVELED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676905 ↗
• MalfunctionApr 4, 2019Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  A COUGAR GUIDEWIRE WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A NON TORTUOUS, NON CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE PROXIMAL RCA. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING AS PER IFU. THE DEVICE WAS NOT INSPECTED. THE DEVICE WAS NOT PREPPED AS PER IFU. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE COUGAR WAS BEING USED WITH A 1.5X10MM EUPHORA BALLOON CATHETER. THE GUIDEWIRE WAS INTRODUCED INTO THE ARTERY. LATER THE BALLOON WAS INTRODUCED INTO THE ARTERY. THERE WAS NO PROBLEM DURING INSERTION. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE. AN IMAGE PROVIDED INDICATES THAT THE EUPHORA BALLOON CAUGHT ON THE GUIDE WIRE AND BECAME SEVERELY DEFORMED. IT WAS REPORTED THAT THE DAMAGE TO THE EUPHORA WAS DUE TO THE COUGAR WIRE. WHEN IT WAS TIME TO REMOVE THE MATERIAL FROM THE PATIENT'S BODY, THE BALLOON BECAME ENTRAPPED ON THE WIRE AND COULD N OT BE REMOVED, AND THE EUPHORA BECAME DAMAGED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483069 ↗
• MalfunctionMar 23, 2018Kinked; Material Deformation; Kinked; Material Deformation

  THE PHYSICIAN INTENDED TO USE A COUGAR XT J-TIP GUIDE WIRE. IT IS REPORTED THAT THE PHYSICIAN STATED MALFUNCTION OF THE GUIDEWIRE DURING ATTEMPTED LEAD IMPLANT. THE PHYSICIAN ALSO SPECIFIED THAT IT WAS NOT A LEAD ISSUE. THE PHYSICIAN NOTED THAT THERE WAS NO CALCIFICATIONS AS THE DEVICE WAS USED IN THE VEIN FOR CRT WITH ONE OF THE LV LEADS. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365147 ↗
• InjuryMar 14, 2018Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  THE PHYSICIAN IMPLANTED AN RESOLUTE ONYX STENT IN THE 1ST DIAGONAL. IT IS REPORTED THAT THE STENT HAD FORE- SHORTENING, AND THAT A COUGAR XT GUIDEWIRE BECAME ENTANGLED IN THE STENT. DURING THE PROCEDURE THE DISTAL TIP OF THE COUGAR XT GUIDEWIRE BROKE OFF, WITH APPROXIMATELY 3 CM OF THE DISTAL TIP REMAINING IN THE PATIENT. THE WIRE WAS TRAPPED IN THE VESSEL BECAUSE IT COULD NOT BE RETRIEVED OR SNARED AT THAT TIME. NO RESISTANCE WAS FELT AT THE TIME OF WIRE PLACEMENT, BUT WAS GOING THROUGH THE ENTANGLED STENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN A STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7337191 ↗
• MalfunctionJan 17, 2018Break; Material Deformation; Break; Material Deformation

  THE PHYSICIAN INTENDED TO USE A COUGAR GUIDEWIRE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING FROM THE PACKAGING PER IFU. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS NOT PREPPED PER IFU. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. THE LESION WAS IN THE POSTERO-LATERAL TRUNK. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT DURING REMOVAL THE DISTAL END WAS DAMAGED BUT DID NOT COME OFF THE DEVICE.THE DEVICE WAS REMOVED BY PULLING IT OUT OF THE PATIENT. NO INTERVENTION WAS REQUIRED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7199541 ↗
• MalfunctionNov 21, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A COUGAR GUIDEWIRE TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU WITH NO ISSUES. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT WHEN THE PHYSICIAN WENT TO EXTRACT THE DEVICE FROM THE PATIENT IT BEGAN TO UNRAVEL. THERE WAS NO RESISTANCE WHEN THE PHYSICIAN WAS EXTRACTING THE WIRE. NO PORTION OF THE WIRE REMAINS IN THE PATIENT, WHICH WAS CONFIRMED THROUGH FLUOROSCOPY. THERE IS NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047864 ↗
• InjuryNov 14, 2017Delamination; Detachment of Device or Device Component; Material Deformation; Delamination; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN USED A COUGAR WIRE DURING A PRIMARY ANGIOPLASTY PROCEDURE IN A MILD TORTUOSITY, NON-CALCIFIED VESSEL. NO DAMAGE WAS NOTED TO PACKAGING (SHELF CARTON, INNER PACKAGING, HOOP). NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING IT FROM THE PACKAGING AS PER IFU. THE WIRE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE COATING WAS MOISTENED PRIOR TO USE. IT IS REPORTED THAT WHILE DELIVERING THE WIRE TO THE LESION THE GREEN OUTER COATING HAD GIVEN WAY AND THE WIRE WAS DELAMINATING. THE WIRE WAS STUCK IN THE DIAGONAL ARTERY, AND WHILST TRYING TO PUT IT BACK INTO THE LAD, IT WAS NOTICED THAT THE TORQUE WAS NOT GETTING TRANSMITTED. DURING THE ATTEMPT TO REMOVE THE ENTIRE SYSTEM, IT WAS NOTICED THAT WIRE DELAMINATION OCCURRED EITHER AT THE JUNCTION OF THE DISTAL 30 MM AND THE HARDER PART OF THE WIRE OR A BIT MORE PROXIMALLY AT THE LEVEL OF THE PROXIMAL LAD. HENCE THE WIRE WAS REMOVED DUE TO COATING ISSUES. AS THE WIRE WAS RETRACTED, IT IS INDICATED THAT THE WIRE CONTINUED TO STRETCH. NO DEVICE HAD BEEN LOADED ONTO THE WIRE WHEN THIS EVENT OCCURRED. THE PATIENT UNDERWENT EMERGENCY CABG. ONE PIECE OF THE WIRE WAS RETRIEVED I

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7028039 ↗
• MalfunctionAug 17, 2017Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  THE PHYSICIAN USED A COUGAR GUIDE WIRE WHEN TREATING A LESION IN THE MID LAD; LESION WAS NON-TORTUOUS AND MODERATELY CALCIFIED. THE LESION WAS PRE-DILATED. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING PER IFU. THE GUIDEWIRE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE GUIDEWIRE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE, EXCESSIVE FORCE WAS NOT APPLIED. DURING THE PROCEDURE THE GUIDEWIRE WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED MEDTRONIC STENT HOWEVER THE TIP OF THE GUIDEWIRE GOT CAUGHT IN A STENT STRUT. THE PREVIOUSLY DEPLOYED STENT WAS NOT DISPLACED, THE GUIDEWIRE GOT STUCK BETWEEN THE STRUT OF THE STENT PREVIOUSLY IMPLANTED AND THE VESSEL. IT IS INDICATED THAT THE GUIDE WIRE TIP DID NOT BREAK OFF, IT GOT STUCK AND THE FIBRES BECAME LOOSE. THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799836 ↗