COUGAR® XT CGRXT190HS (UDI 00763000570132)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000570132), received between Nov 21, 2023 and Feb 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRT IMPLANTATION PROCEDURE THE PATIENT SUFFERED A TAMPONADE FROM A PERFORATION IN THE NON-TORTUOUS, NO N-CALCIFIED CORONARY SINUS (CS). THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE RV LEAD AND RA LEAD WERE SUCCESSFULLY POSITIONED. ALL MEASUREMENTS WERE WITHIN THE NORMAL RANGE. THE CS CAT HETER WAS FLUSHED AND ADEQUATELY PREPARED. A 0.035" NON-MEDTRONIC WIRE, A 6250VI-MP CATHETER AND AN AL1, 6F GUIDING CATHETER WERE ADVANCED TO THE CS. THE CS WAS PROBED WITH THE WIRE AND THE AL1, AND THE 6250VI-MP CATHETER WAS INTRODUCED OVER THE WIRE. CONTRAST MEDIUM WAS INJECTED TO CONFIRM THE POSITIONING. THE 6215 BALLOON CATHETER WAS THEN INTRODUCED TO VISUALIZE THE CS. THE 6215 BALLOON CATHETER WAS FLUSHED AND ADVANCED USING A COUGAR XT GUIDEWIRE OVER THE EXISTING CS CATHETER. THE COUGAR GUIDEWIRE WAS INSPECTED BEFORE USE AND PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. AFTER ADVANCING THE 6215 BALLOON CATHETER, THE COUGAR XT GUIDEWIRE WAS REMOVED, AND THE 6215 BALLOON WAS INFLATED AFTER POSITIONING WAS CONFIRMED WITH CONTRAST MEDIUM. A CS VISUALIZATION W

  Patient problems: Cardiac Tamponade; Chest Pain; Insufficient Information; Low Blood Pressure/ Hypotension; Perforation; Vascular Dissection

  MAUDE report 21372280 ↗
• InjuryNov 21, 2023Entrapment of Device; Detachment of Device or Device Component; Device Damaged by Another Device; Entrapment of Device; Detachment of Device or Device Component; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDEWIRE DURING A PROCEDURE TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE WIRE TIP WAS FORMED BY THE PHYSICIAN. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE DETACHED INSIDE THE PATIENT. AFTER DEPLOYING TWO STENTS AN ATTEMPT WAS MADE TO REMOVE THE COUGAR WIRE FROM THE VESSEL. HOWEVER, RESISTANCE WAS NOTICED AND THE WIRE APPEARED TO GET TANGLED IN THE MORE DISTAL STENT. THE WIRE HAD BEEN PROLAPSED OVER IN THE DISTAL VESSEL WHILE STENTING, AND IT IS POSSIBLE THE LOOP FROM THE PROLAPSED WIRE CAUGHT A STENT STRUT UPON REMOVAL. THE WIRE WAS FRACTURED IN AN ATTEMPT TO REMOVE THE WIRE FROM THE VESSEL. THE VESSEL WAS THEN RE-WIRED AND THE ENTIRE VESSEL WAS STENTED FROM 15MM DISTAL TO THE TWO ORIGINALLY DEPLOYED STENTS, ALL THE WAY TO THE OSTIUM OF THE RCA. THE PLAN WAS TO TRAP WHAT WAS POSSIBLY LEFT OF THE FRACTURED WIRE IN THE VES

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

  MAUDE report 18180193 ↗