COUGAR XTRecalls & reported problems across all models

We found 7 models of COUGAR XT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2017 and Feb 13, 2025 — classified as 17 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported COUGAR XT problems

COUGAR XT models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• COUGAR® XT CGRXT190HS

  WIRE, GUIDE, CATHETER
  19 reports
• COUGAR® XT CGRXT190HJ

  WIRE, GUIDE, CATHETER
  8 reports
• COUGAR® XT CGRXT300HS

  WIRE, GUIDE, CATHETER
  3 reports
• COUGAR® XT LVCXT190J

  WIRE, GUIDE, CATHETER
  3 reports
• COUGAR® XT CGRXT190S

  WIRE, GUIDE, CATHETER
  2 reports
• COUGAR® XT CGRXT190HS

  Wire, guide, catheter
  2 reports
• COUGAR® XT CGRXT190J

  WIRE, GUIDE, CATHETER
  1 report

Recent COUGAR XT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 THE DISTAL RCA. IT WAS REPORTED THAT THE TIP DETACHED WHILE IN THE PATIENT. IT WAS STATED THAT THE PHYSICIAN WAS UNABLE TO GET A STENT DOWN TO TRAP ENTIRELY. THE DETACHED PORTION REMAINS IN THE PATIENT. NO FURTHER PATIENT INJURY REPORTED.

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

  MAUDE report 10703736 ↗
• 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 ↗

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