COUGAR® LS CGRLS190HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169452893), received between Jun 30, 2017 and Mar 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE OF A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDEWIRE AND ONE LEFT VENTRICULAR (LV) LEAD IN A NON-TORTUOUS, NON-CALCIFIED LESION IN THE LATERAL POSTERIOR VEIN IN THE SUBCLAVIAN VEIN ACCESS. THE GUIDEWIRE WAS INSPECTED WITH NO ISSUES NOTED. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE LESION WAS NOT PRE-DILATED. THE GUIDEWIRE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE GUIDEWIRE WAS STUCK INSIDE THE LEAD WHEN THE VEIN WAS ALREADY CANNULATED. DIFFICULTIES WERE NOT ENCOUNTERED WHEN THE GUIDEWIRE WAS LOADED INTO THE LEAD, HOWEVER, IT BECAME STUCK IN THE LEAD. THE GUIDEWIRE AND ELECTRODE WERE REMOVED. THE PRODUCTS COULD BE PULLED APART AND SEPARATED ONCE OUT OF THE PATIENT. THE TIP WAS FRAYED. A NEW HYBRID GUIDEWIRE AND A NEW LEAD WERE THEN USED, AND THE IMPLANT ENDED WITH NO FURTHER ISSUES. THE GUIDEWIRE WAS NOT SUCCESSFULLY USED PRIOR TO THE DIFFICULTIES OCCURRING. NO OTHER DEVICES WERE BEING USED WITH THE GUIDEWIRE WHEN THE ISSUE OCCUR RED. IT WAS DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485227 ↗
• MalfunctionJun 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED THAT A COUGAR GUIDE WIRE RUPTURED INSIDE AN ATTAIN LEAD DURING A LEAD PLACEMENT PROCEDURE. THE LEAD WAS BEING PLACED IN THE CS, POST LAT VEIN. THE VESSEL WAS MILDLY TORTUOUS WITH NO CALCIFICATION. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT A NEW ATTAIN LEAD WAS USED. NO DAMAGE WAS NOTED TO PACKAGING OF THE COUGAR WIRE. THE WIRE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS NOT PREPPED PER IFU. THE WIRE TIP WAS NOT FORMED BY THE PHYSICIAN. THE WIRE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE WIRE, AND EXCESSIVE FORCE WAS NOT USED. THE WIRE DETACHED DURING REMOVAL. ALL PORTIONS OF THE COUGAR WIRE SUCCESSFULLY REMOVED FROM THE PATIENT. THE WIRE WAS REMOVED WITH THE LEAD. ONE PORTION IS INSIDE THE LEAD. THE LEAD WAS REMOVED. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THE EVENT BUT THE PATIENT STATUS IS REPORTED AS ALIVE - NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680845 ↗