TelescopeRecalls & reported problems across all models

We found 2 models of Telescope by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Jul 17, 2019 and Mar 25, 2026 — classified as 2 deaths, 22 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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 Telescope problems

Telescope models

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

• Telescope™ TELE6F

  Catheter, percutaneous
  2 deaths50 reports
• Telescope™ TELE7F

  Catheter, percutaneous
  3 reports

Recent Telescope adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionNov 22, 2024Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) AND A DEVICE DETACHMENT OCCURRED. IT WAS STATED THAT DURING ADVANCEMENT THROUGH THE GUIDE THE TELESCOPE BROKE. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER AS IT WAS STILL CONNECTED. THE DEVICE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. THE PATIENT IS ALIVE WITHNO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757474 ↗
• 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 ↗
• InjuryApr 4, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 7F TELESCOPE GUIDE EXTENSION CATHETER 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 SHAFT DETACHED AT THE ENTRY PORT DURING DELIVERY TO/AT THE LESION. THE DETACHED FRAGMENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040757 ↗
• 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 ↗

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