Telescope™ TELE6FRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00763000156954), received between Jul 17, 2019 and Mar 25, 2026 — classified as 2 deaths, 21 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (24 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Entrapment of Device; Peeled/Delaminated; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS STATED THAT THE ONYX FRONTIER STENT CAME OFF INSIDE THE TELESCOPE WHEN THE STENT COULD NOT BE DELIVERED TO THE LESION. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS. BOTH DEVICES WERE INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE ONYX FRONTIER DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE ONYX FRONTIER DEVICE AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE. EXCESSIVE FORCE WAS USED DURING DELIVERY OF BOTH DEVICES. IT WAS NOTED THAT THE STENT FELT TIGHT IN THE TELESCOPE DURING REMOVAL OF THE STENT. THE DISLODGED STENT WAS REMOVED WITHIN THE TELESCOPE TOGETHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686902 ↗
• MalfunctionMar 9, 2026Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER, STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE ONYX FRONTIER STENT GOT CAUGHT ON THE BRAIDED INNER SECTION OF THE DISTAL PORTION OF THE TELESCOPE. WHEN THE ONYX FRONTIER STENT WAS PULLED OUT OF THE 6F TELESCOPE, THE BRAIDING UNRAVELED. THE TARGET LESION WAS LOCATED IN THE MID OBTUSE MARGINAL (OM) ARTERY WHICH EXHIBITED SEVERE TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO THE ATTEMPTED STENT DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE. THE DISLODGED STENT WAS REMOVED WHEN THE GUIDE EXTENSION CATHETER WAS WITHDRAWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543070 ↗
• InjuryJan 14, 2026Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE TELESCOPE GUIDE EXTENSION CATHETER, THE TIP OF THE CATHETER DETACHED DURING DELIVERY TO/AT LESION IN THE DIAGONAL BRANCH. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES NOTED. DURING ATTEMPTED LITHOPLASTY OF DIAGONAL, A BALLOON AND A TELESCOPE GEC BECAME ENTRAPPED IN LESION AND COULD NOT BE REMOVED. THE TELESCOPE TIP BROKE OFF. A SECOND GUIDE WAS ADVANCED IN PARALLEL USING FEMORAL ACCESS. A GUIDEWIRE AND A BALLOON WAS ADVANCED NEXT TO THE RETAINED TELESCOPE AND BALLOON. PTCA WAS PERFORMED. THE RETAINED BALLOON AND TELESCOPE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE SMALL TIP OF TELESCOPE STILL REMAINED IN THE DIAGONAL BRANCH AT THE END OF THE CASE. IVUS ON BUDDY WIRE SHOWED NO CATHETER EXTENDING BACK INTO LM OR AORTA. THE DIAGONAL WAS 100% OCCLUDED AT THE END OF THE CASE AND UNABLE TO REWIRE AND DILATE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR SUPPORTIVE MANAGEMENT OF DIAGONAL BRANCH TERRITORY INFARCT. IT WAS REPORTED THAT IT OCCURRED DUE TO DIFFICULT PATIENT ANATOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 24071760 ↗
• InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CORONARY INTERVENTION INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. AS THE RESOLUTE ONYX DEVICE WAS BEING PULLED BACK INTO THE TELESCOPE, THE STENT CAME OFF THE BALLOON AT THAT POINT. THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY WHICH EXHIBITED MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 100% LESION STENOSIS. A DISSECTION WAS NOTED DISTAL TO THE LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DISLODGED STENT WAS NOT REMOVED AND REMAINS IN THE PATIENT. A 1.25MM SPRINTER BALLOON WAS USED AS AN INTERVENTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Dyspnea; Ischemia; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Pulmonary Edema

  MAUDE report 23804142 ↗
• InjuryJun 13, 2025Difficult to Remove; Detachment of Device or Device Component; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE 6F TELESCOPE EXTENSION GUIDE CATHETER (GEC), POSITIONING DIFFICULTIES WERE EN COUNTERED AND THE TIP OF THE TELESCOPE DETACHED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MODERATELY-SEVERELY CALCIFIED, ECCENTRIC FOCAL LESION WITH 90% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE TELESCOPE GEC WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE TELESCOPE GEC WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. ONE COMPLIANT BALLOON RUPTURED AT THE LESION BUT WAS RELEASED USING A NON-COMPLAINT BALLOON WITH A LOCAL DISSECTION NOTED. BALLOON DILATION WAS PERFORMED OUTSIDE THE TELESCOPE GEC, HOWEVER THE TELESCOPE GEC WOULD NOT PASS BEYOND THIS POINT IN ARTERY BUT WITH THE GUIDE GAVE ADEQUATE SUPPORT TO PLACE THE DISTAL STENT. UPON PLACEMENT OF THE SECOND STENT THAT EXTENDED PROXIMAL TO THE TELESCOPE GEC, THE TIP CAME OFF THE TELESCOPE DURING REMOVAL WITH ONLY MILD EXTRACTION PRESSURE WITH THE GUIDE FOR PROXIMAL STENT POSITIONING. THE PATIENT UNDERWENT AN URGENT CORONARY ARTERY BYPASS GRAFT (CABG). NO FURTHE

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

  MAUDE report 22201560 ↗
• InjuryApr 4, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) DETACHED DURING REMOVAL. THE LESION BEING TREATED WAS MILDLY TORTUOUS, SEVERELY CALCIFIED WITH 80-90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE HAD BEEN PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PATIENT HAD A PREVIOUSLY DEPLOYED STENT IN THE AREA. A BALLOON WAS INFLATED OVER THE PROXIMAL LESION TO INCHWORM THE TELESCOPE TIP TO THE DISTAL LESION. THE TELESCOPE TIP GOT STUCK IN THE DISTAL LESION AND DURING ATTEMPTS TO REMOVE THE DEVICE THE TIP DETACHED. A SMALL BALLOON WAS ADVANCED THROUGH THE TELESCOPE TIP, INFLATED, AND AN ATTEMPT WAS MADE TO EXTRACT THE TIP BY PULLING THE INFLATED BALLOON BACK TOWARD THE GUIDE, BUT THIS WAS UNSUCCESSFUL. THE TELESCOPE TIP COULD NOT TRAVERSE BACK THROUGH THE PROXIMAL LESION. THE PATIENT WAS TRANSFERRED TO A QUALIFIED FACILITY FOR POSSIBLE SURGICAL REMOVAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21772050 ↗
• InjuryFeb 21, 2025Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO/AT THE LESION. THE STENT WAS BEING USED WITH ONE TELESCOPE GUIDE EXTENSION CATHETER WHEN THE STENT CAME OFF THE DELIVERY SYSTEM. THERE WAS DAMAGE TO THE STENT DEVICE. THE DISLODGED STENT WAS NOT REMOVED. THE PATIENT WENT TO SURGERY TO OPEN THE SHUT DOWN VESSEL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 21431733 ↗
• InjurySep 20, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. THE PATIENT WAS NOTED TO HAVE VERY BAD ANATOMY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED DURING DELIVERY TO THE LESION. MULTIPLE BALLOONS AND SHOCKWAVE WERE USED TO TRY AND RETRIEVE THE DETACHED PORTION. A LOT OF PUSH FORCE HAD TO BE USED TO GET THE VARIOUS BALLOONS DOWN. EVENTUALLY, IT WAS FELT GIVE AND IT WAS POSSIBLE TO BRING BACK IN THE GUIDE AND RETRIEVE ALL THE PIECES. THE DEVICE WAS TAKEN OUT ALONG WITH THE BALLOON SLIGHTLY INFLATED WHICH ACTED AS A BACK STOP. THE GUIDE WAS CUT OUTSIDE OF THE BODY TO VERIFY NOTHING WAS LEFT IN THE BODY. ALL THE DETACHED PIECES WERE REMOVED. THE LESION WAS ULTIMATELY STENTED WITH NO PATIENT INJURY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20265694 ↗
• MalfunctionMay 3, 2024Entrapment of Device; Component Missing; Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Advance; Material Deformation; Entrapment of Device; Component Missing; Detachment of Device or Device Component; Device Damaged by Another Device; Difficult to Advance; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC)AND ONE 6F LAUNCHER GUIDE CATHETER DURING A PROCEDURE IN A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING USE WITH THE TELESCOPE PRIOR TO EXITING THE GUIDE CATHETER INTO THE ARTERY. THE TELESCOPE WAS NOT EXCESSIVELY TORQUED. UPON REMOVAL OF THE TELESCOPE AND THE GUIDE CATHETER IT WAS NOTED THERE APPEARED TO BE A KINK TO THE DISTAL ASPECT OF THE GUIDE CATHETER JUST AT THE CURVE AND THERE APPEARED TO BE A FLAT SPOT TOWARDS THE PROXIMAL END. IT WAS REPORTED THAT THE KINK OCCURRED INSIDE THE PATIENT WHILE CANNULATING THE RCA. IT WAS SUGGESTED THAT THIS CAUSED THE TELESCOPE TO UNRAVEL ON REMOVAL FROM THE PATIENT PRIOR TO THE PROCEDURE BEING FINISHED. THE PROCEDURE WAS COMPLETED WITH A NEW LAUNCHER AND NEW TELESCOPE DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19238279 ↗
• MalfunctionMay 1, 2024Difficult to Remove; Component Missing; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Advance; Material Deformation; Difficult to Remove; Component Missing; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Advance; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUE. IT WAS REPORTED THAT THE TIP OF THE TELESCOPE BROKE OFF DURING DELIVERY TO/AT THE LESION. IT WAS ALSO REPORTED THAT A FRAGMENT REMAINS IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220548 ↗
• MalfunctionApr 16, 2024Defective Device; Detachment of Device or Device Component; Material Deformation; Defective Device; Detachment of Device or Device Component; Material Deformation

  ONE TELESCOPE GUIDE EXTENSION CATHETER WAS RETURNED TO MEDTRONIC. IT WAS INDICATED THAT THE DEVICE WAS DEFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114075 ↗
• InjuryApr 10, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Difficult to Advance; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Difficult to Advance

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER AND ONE 3.5X38MM ONYX FRONTIER STENT TO TREAT A SEVERELY TORTUOUS, NON-CALCIFIED LESION WITH 95% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE TELESCOPE DEVICE WAS INSPECTED WITH NO ISSUES. THE TELESCOPE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING INSERTION/DELIVERY. IT WAS REPORTED A TIP DETACHMENT OF THE TELESCOPE OCCURRED. A RADIAL APPROACH WAS USED. A JR4 LAUNCHER GUIDE CATHETER WAS DEEPLY SEATED INTO THE RCA. THE TELESCOPE MADE IT TO THE MID VESSEL. WHEN RETRACTING THE TELESCOPE AFTER UNSUCCESSFUL DELIVERY OF THE 3.5X38MM ONYX FRONTIER STENT, IT WAS FELT THAT THE TELESCOPE RETRACTED FARTHER THAN EXPECTED BASED ON THE AMOUNT OF DISTANCE IT SHOULD HAVE RETRACTED. IT WAS THEN NOTICED THAT THE TIP HAD SEPARATED. IT WAS POSSIBLE TO RETRIEVE THE DETACHED TIP ON THE UNDELIVERED STENT, AS IT REMAINED ATTACHED TO THE STENT. THEN TWO 3.5X12MM ONYX FRONTIER STENTS WERE USED TO STENT THE AREA WHERE INITIALLY THE 3.5X38MM ONYX FRONTIER STENT WAS ATTEMPTED TO BE DELIVERED. FINALLY, A 4.0X12MM ONYX FRONTIER STENT WAS USED TO COVER AN

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

  MAUDE report 19077208 ↗
• MalfunctionApr 2, 2024Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component; Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) IN A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING REMOVAL OF A 3.5 X 12MM NON-MEDTRONIC INTRAVASCULAR LITHOTRIPSY (IVL) BALLOON THROUGH THE LUMEN OF THE TELESCOPE. IT WAS DETAILED RESISTANCE WAS FELT WHEN WITHDRAWING THE BALLOON BACK INTO THE TIP OF THE TELESCOPE POST INFLATION. THE BALLOON BECAME STUCK DURING REMOVAL. THE IVL BALLOON AND NON-MEDTRONIC GUIDEWIRE WERE ENTRAPPED IN THE TELESCOPE. THE GUIDEWIRE, TELESCOPE AND IVL BALLOON WERE PULLED OUT OF THE VESSEL AND 6F LAUNCHER GUIDE CATHETER TOGETHER SUCCESSFULLY. EXCESSIVE FORCE WAS USED DURING REMOVAL. SUFFICIENT TIME WAS GIVE TO ALLOW THE BALLOON TO FULLY DEFLATE PRIOR TO ATTEMPTING REMOVAL. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES NOTED. THE IVL BALLOON WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018060 ↗
• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE LAUNCHER GUIDE CATHETER, ONE EUPHORA BALLOON CATHETER, FIVE NC EUPHORA BALLOON CATHETERS, AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A SPONTANEOUS MYOCARDIAL INFARCTION (MI) AND CARDIAC ARREST / SUDDEN CARDIAC DEATH. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE, HAD EATEN DINNER AND EVERYTHING WAS NORMAL WHEN SUDDENLY THE PATIENT COLLAPSED ON THE GROUND. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF CHEST PAIN, DIAPHORESIS, NAUSEA, OR VOMITING. ADVANCED LIFE SAVING MEASURES WERE UTILIZED. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND A FAMILY MEMBER TRIED TO DO SOME MOUTH-TO-MOUTH UNTIL THE AMBULANCE ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY DETECTED ELECTROMECHANICAL DISSOCIATION (EMD) AND STARTED CARDIOPULMONARY RESUSCITATION (CPR) FOR 30 MINUTES BEF ORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. T

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947594 ↗
• MalfunctionJan 26, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER AND ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE VESSEL TORTUOSITY AND CALCIFICATION MADE IT DIFFICULT FOR PASSAGE OF EQUIPMENT. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON THE ONYX FRONTIER WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE ONYX FRONTIER DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE TIP OF THE TELESCOPE DEVICE, AND STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE TIP OF THE TELESCOPE TIP WAS TORN. THE STENT SNAGGED ON THE TIP OF THE TELESCOPE CATHETER AND CAME OFF THE DELIVERY SYSTEM. AFTER REMOVING THE TELESCOPE DEVICE, THE STENT WAS ABLE TO BE RETRIEVED BY USING A SMALLER PLATFORM. ALL DEVICES WERE RETRIEVED EVENTUALLY WITH NO ADVERSE EFFECTS ON THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18585801 ↗
• InjuryDec 19, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE TIP OF THE TELESCOPE DETACHED DURING DELIVERY TO/AT THE LESION. IT WAS DETAILED THAT A STENT WAS DELIVERED SUCCESSFULLY HOWEVER, WHEN ATTEMPTING TO ADVANCE A NC BALLOON, THE BALLOON FAILED TO BE DELIVERED AND THE TIP OF THE TELESCOPE BROKE OFF. THE DETACHED TIP FRAGMENT WAS REMOVED WITH A BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18355918 ↗
• MalfunctionDec 18, 2023Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE GEC. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED WHEN THE STENT WAS BEING ADVANCED THROUGH THE TELESCOPE. IT WAS DETAILED THAT THE STENT GOT STUCK ON THE TELESCOPE 6F CATHETER AND WAS DEFORMED. IT WAS NOTED THAT STENT DISLODGEMENT ALSO OCCURRED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350238 ↗
• MalfunctionNov 14, 2023Positioning Failure; Difficult to Advance; Device Dislodged or Dislocated; Positioning Failure; Difficult to Advance; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) DEVICE AND ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION. THE DEVICES WERE REMOVED FROM THE PACKAGING AS PER IFU, WITH NO ISSUES NOTED. THE DEVICES WERE INSPECTED, WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED AS PER IFU, WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED WHEN ADVANCING THE TELESCOPE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE ONYX FRONTIER DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WOULD NOT PASS THROUGH THE TELESCOPE DEVICE. THE STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS STRIPPED OFF THE DELIVERY SYSTEM OUTSIDE THE BODY IN CO-PILOT HEMOSTAT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133129 ↗
• MalfunctionJul 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO DELIVER THE ONYX FRONTIER STENT HOWEVER, IT FAILED TO CROSS THE LESION. A SECOND ATTEMPT WAS MADE TO DELIVER THE STENT USING A TELESCOPE GEC. IT WAS DETAILED THAT THE STENT GOT CAUGHT WHEN IT WAS PULLED BACK INTO THE TELESCOPE ALONG THE GUIDEWIRE. WHEN THE TELESCOPE WAS REMOVED, THE DISLODGED STENT WAS FOUND ON THE TELESCOPE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378496 ↗
• MalfunctionJul 13, 2023Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION WITH 86% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT BECAME STUCK IN THE TELESCOPE 6F GUIDE EXTENSION CATHETER. IT WAS DETAILED THAT AN INITIAL DELIVERY OF THE STENT WAS ATTEMPTED WITHOUT THE USE OF THE TELESCOPE. IT WAS SUSPECTED THAT THE STENT MAY HAVE BEEN DAMAGE WHEN PUSHING AGAINST THE PREVIOUSLY DEPLOYED STENT THAT WAS PLACED MORE PROXIMAL TO THE SECONDARY LESION BEING TREATED. THE DISLODGED STENT WAS REMOVED TOGETHER WITH THE TELESCOPE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320152 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) IN A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% LESION STENOSIS IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE DEVICE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE TELESCOPE BEGAN TO UNRAVEL TOWARDS THE TIP OF THE CATHETER. THE DEFORMATION WAS NOTED WHEN ADVANCING THE DEVICE IN THE VESSEL, AND AFTER THE DEVICE HAD BEEN REMOVED FROM THE PATIENT. A TELESCOPE DETACHMENT WAS NOT NOTED. THE TELESCOPE WAS REMOVED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238565 ↗
• InjuryMay 18, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) IN A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE OSTIUM/PROXIMAL/MID/DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED DURING REMOVAL, AND THE TIP CAME OFF THE CATHETER. AN ATTEMPT WAS MADE TO REMOVE THE DETACHED TIP WITH A SNARE, BUT THE TIP WASN'T REMOVED DURING THE PROCEDURE. THE TIP REMAINS IN THE RCA. THE PATIENT IS STABLE WITH NO FURTHER INJURY.

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

  MAUDE report 16951490 ↗
• MalfunctionMay 10, 2023Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE 6F GUIDE EXTENSION CATHETER TO TREAT A SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE DEVICE. THE DEVICE HAD UNRAVELED. IT WAS ALSO DETAILED THAT A NON-MEDTRONIC WIRE AND SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) WERE USED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900791 ↗
• InjuryApr 24, 2023Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) IN MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. MULTIPLE PRE-DILATIONS OF THE LESION WERE PERFORMED WITH MULTIPLE DIFFERENT MEDTRONIC (MDT) AND NON-MDT BALLOONS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE TIP OF THE TELESCOPE DETACHED DURING DELIVERY TO THE LESION. A BALLOON WAS USED TO PULL THE TIP BACK FROM THE LAD INTO THE LEFT MAIN AND INTO THE GUIDE CATHETER. THE DISLODGED TIP WAS REMOVED FROM THE PATIENT SAFELY. THERE WAS AN OLD STENT IN THE LEFT MAIN THAT EXTENDED INTO THE LEFT CIRCUMFLEX ARTERY, AND THE TELESCOPE GOT CAUGHT IN THIS OLD STENT. IT WAS DETAILED DURING THE PROCEDURE THATA 2.5 X 23MM NON-MDT STENT WAS INSERTED AND DEPLOYED. THEN A 3 X 38MM NON-MDT STENT WAS INSERTED BUT REMOVED UNDEPLOYED. FURTHER PRE-DILATION WAS PERFORMED WITH A 2.5 X 12MM NC EUPHORA BALLOON CATHETER WITH INFLATIONS OF 15 ATM FOR 6 SECONDS, 16 ATM FOR 18 SECONDS, AND 16 ATM

  Patient problems: Insufficient Information

  MAUDE report 16795216 ↗
• InjuryFeb 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE ONYX FRONTIER STENT WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED FOR THE ONYX FRONTIER STENT PRIOR TO ADVANCING THE DEVICE TO THE LESION WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE ONYX FRONTIER STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOTED WHEN ADVANCING THE ONYX FRONTIER STENT BUT EXCESSIVE FORCE WAS NOT USED. THE TELESCOPE GEC WAS INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT IT WAS ATTEMPTED TO DELIVER THE ONYX FRONTIER STENT THROUGH A LESION WITH EXTREME TORTUOSITY AND CALCIFICATION USING THE TELESCOPE. IT WAS BELIEVED THAT THE STENT CAME OFF THE DELIVERY SYSTEM WHEN PULLING THE UNDEPLOYED STENT INTO THE TELESCOPE. THE DISLODGED STENT WAS REMOVED F ROM PATIENT B

  Patient problems: Insufficient Information

  MAUDE report 16320650 ↗