SPRINTER LEGENDRecalls & reported problems across all models

We found 19 models of SPRINTER LEGEND by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Jun 23, 2017 and Nov 13, 2025 — classified as 1 death, 17 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (16 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 SPRINTER LEGEND problems

SPRINTER LEGEND models

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

• SPRINTER® LEGEND SPL25015X

  Catheters, transluminal coronary angioplasty, percutaneous
  6 reports
• SPRINTER® LEGEND SPL25012X

  Catheters, transluminal coronary angioplasty, percutaneous
  5 reports
• SPRINTER® LEGEND SPL20012X

  Catheters, transluminal coronary angioplasty, percutaneous
  4 reports
• SPRINTER® LEGEND SPL12510X

  Catheters, transluminal coronary angioplasty, percutaneous
  4 reports
• SPRINTER® LEGEND SPL20015X

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• SPRINTER® LEGEND SPL15020X

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• SPRINTER® LEGEND SPL12515X

  Catheters, transluminal coronary angioplasty, percutaneous
  3 reports
• SPRINTER® LEGEND SPL25020X

  Catheters, transluminal coronary angioplasty, percutaneous
  2 reports
• SPRINTER® LEGEND SPL12506X

  Catheters, transluminal coronary angioplasty, percutaneous
  2 reports
• SPRINTER® LEGEND SPL12512X

  Catheters, transluminal coronary angioplasty, percutaneous
  2 reports
• Sprinter Legend™ SPL12515WL

  Catheters, transluminal coronary angioplasty, percutaneous
  1 death2 reports
• SPRINTER® LEGEND SPL30020X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® LEGEND SPL30015X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® LEGEND SPL20020X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® LEGEND SPL15012X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® LEGEND SPL20006X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® LEGEND SPL15015X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• SPRINTER® LEGEND SPL22512X

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report
• Sprinter Legend™ SPL12510WL

  Catheters, transluminal coronary angioplasty, percutaneous
  1 report

Recent SPRINTER LEGEND adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2025Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE SPRINTER LEGEND RX BALLOON, THE BALLOON DETACHED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THE LESION BEING TREATED WAS A MODERATELY TORTUOUS, SEVERELY CALCIFIED WITH 100% CHRONIC TOTAL OCCLUSION (CTO) INTHE DISTAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE SPRINTER LEGEND BALLOON WAS ADVANCED TO THE LESION SITE USING A TELESCOPE GUIDE EXTENSION CATHETER (GEC). THERE WERE MULTIPLE INFLATIONS TO 12ATM PERFORMED. UPON RETRIEVAL, THE SPRINTER LEGEND BALLOON SHEARED AT THE MARKER, RESULTING IN A PORTION OF THE MID MARKER AND SOME BALLOON MATERIAL REMAINING IN THE DISTAL END OF THE OBTUSE MARGINAL BRANCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23542349 ↗
• MalfunctionOct 15, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE SPRINTER LEGEND BALLOON, THE CATHETER/DELIVERY SYSTEM WAS FOUND TO BE DEFORMED AND A KINK WAS NOTED AT THE LUER/HUB. IT WAS ALSO REPORTED THAT THE CATHETER SHAFT WAS BROKEN. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276421 ↗
• InjuryMar 26, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE SPRINTER LEGEND BALLOON CATHETER DETACHED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED WITH 90% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY AND OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION AND THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS INSERTED INTO THE MID CIRCUMFLEX CORONARY IN PREPARATION FOR STENT PLACEMENT. WHEN PLACING THE BALLOON, SOME MANEUVERABILITY WAS REQUIRED BUT NOTHING THAT WOULD BE UNEXPECTED. THE BALLOON WAS INFLATED TO 20 ATM FOR 30 SECONDS. AFTER INFLATION AN ATTEMPT WAS MADE TO WITHDRAW THE BALLOON AT WHICH TIME THE BALLOON DISCONNECTED FROM THE WIRE BREAKING FREE. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE BALLOON WITHOUT SUCCESS. BALLOONS AND WIRES WERE INSERTED TO TRY AND REMOVE THE DETACHED DEVICE AND GET IT TO A PLACE WHERE IT COULD BE SNARED. HOWEVER, THE DETACHED BALLOON REMAINS IN THE

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 21695681 ↗
• InjuryJan 9, 2025Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING THE REMOVAL OF ONE SPRINTER LEGEND DEVICE FOLLOWING INFLATION AT NOMINAL PRESSURE IN A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 60% STENOSIS IN THE DISTAL DIAGONAL BRANCH OF THE ARTERY, A DETACHMENT AT THE TIP OF THE BALLOON CATHETER OCCURRED. DUE TO THE EXTREME CALCIUM, THE BALLOON CATHETER WAS DELIVERED WITH SLIGHT DIFFICULTY. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE AND UPON REMOVAL SHEERED OFF. ATTEMPTS WERE MADE TO SNARE, REWIRE, AND USE A SUCTION DEVICE TO REMOVE THE DETACHED PORTION, BUT THE DISTAL PORTION OF THE CATHETER REMAINED IN THE PATIENT'S DISTAL DIAGONAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE OR EXCESSIVE FORCE WAS NOT ENCOUNTERED DURING DELIVERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 21109774 ↗
• InjuryOct 11, 2024Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND CORONARY BALLOON CATHETER TO TREAT A LESION WITH CHRONIC TOTAL OCCLUSION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS NOT DIFFICULT TO REMOVE THE PROTECTIVE SHEATH OR THE PACKAGING STYLETTE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED THROUGHOUT MULTIPLE TIMES WITH A 1MM NON-MEDTRONIC BALLOON WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. DIFFICULTIES WERE NOTED DURING INFLATION OF THE DEVICE, AS THE BALLOON DID NOT INFLATE EVENLY. AN INFLATION PRESSURE OF 10 ATM WAS APPLIED, AND DEFLATION DIFFICULTIES OCCURRED AFTER THE FIRST INFLATION. THE BALLOON FAILED TO DEFLATE AND REMAINED WEDGED WITHIN THE ARTERY. ATTEMPTS WERE MADE TO TRY AND DEFLATE AND REINFLATE THE BALLOON, BUT THIS DID NOT CHANGE ANYTHING. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE BALLOON WAS INFLATED BEYOND THE RATED BURST PRESSURE TO TRY AND I

  Patient problems: Insufficient Information

  MAUDE report 20425681 ↗
• InjuryMar 7, 2024Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX CORONARY BALLOON CATHETER TO TREAT A LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BROKE AND PERFORATED THE LM ARTERY. THE BALLOON'S INITIAL INFLATION RESULTED IN THE PERFORATION OF THE LM ARTERY. IT WAS STATED THAT PART OF THE BALLOON REMAINS IN THE BODY. A STENT WAS PLACED AND PINNED UP THE PIECE OF BALLOON LEFT IN THE CORONARY ARTERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18855164 ↗
• MalfunctionJan 8, 2024Inflation Problem; Leak/Splash; Material Deformation; Inflation Problem; Leak/Splash; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX BALLOON CATHETER TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION AT 8ATM. IT WAS DETAILED THAT THE BALLOON WOULD NOT INFLATE DURING INFLATION, IT WAS THEN OBSERVED UNDER FLUOROSCOPY THAT THE BALLOON WAS LEAKING. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462247 ↗
• MalfunctionAug 15, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT A BALLOON BURST OR BALLOON LEAK OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548902 ↗
• MalfunctionJun 1, 2022Deflation Problem; Material Deformation; Deflation Problem; Material Deformation

  ONE SPRINTER LEGEND BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A LESION WITH 90% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED TO 12 ATM FOR 22 SECONDS AND THEN FOR 21 SECONDS.  IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE BALLOON WAS INFLATED TO 12 ATM, AN ATTEMPT WAS MADE TO COME DOWN AND GO BACK UP TO 12 ATM AND THEN ATTEMPTED TO COME DOWN AGAIN. THE INFLATION DEVICE WAS CHANGED BUT THAT DID NOT WORK SO THE BALLOON WAS THEN PULLED BACK INTO THE GUIDE AND REMOVED FROM THE PATIENT. A RESOLUTE ONYX STENT WAS DEPLOYED IN THE DISTAL RCA DURING THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14562535 ↗
• InjuryApr 22, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A SEVERELY CALCIFIED AND FIBROTIC LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE BALLOON MATERIAL AND BALLOON SHAFT DETACHED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. IT WAS STATED THAT THE BALLOON WAS PASSED OVER THE GUIDEWIRE AND PROLONGED ATTEMPTS WERE MADE TO CROSS THE FIBROTIC LESION. THE BALLOON DID NOSE INTO THE LESION WITH THE BALLOON MARKER PROXIMALLY LOCATED IN THE MID-SEGMENT OF THE LESION. THE BALLOON WAS INFLATED ABOUT 15 TO 20 TIMES AT PRESSURES UP TP 20 ATM. HOWEVER, THE BALLOON STILL COULD NOT FULLY PASS THE LESION. IT WAS REPORTED THAT ATTEMPTS WERE MADE TO REMOVE THE BALLOON AND DURING REMOVAL ATTEMPTS THE BALLOON TORE AND COULD NOT BE REMOVED FROM THE LESION. IT WAS ALSO REPORTED THAT THE BALLOON SHAFT SNAPPED AT THE PROXIMAL END OF THE BALLOON, AND WAS REMOVED INTACT. AN ATTEMPT WAS THEN MADE TO PASS A 1.5MM NON-MEDTRONIC BALLOON ACROSS THE LESION IN ORDER TO

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

  MAUDE report 14185571 ↗
• MalfunctionJan 18, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE SPRINTER LEGEND BALLOON CATHETER WERE ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 75% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX BUT EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE SPRINTER LEGEND AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED, IT WAS CRUSHED AGAINST THE VESSEL WALL. IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES OCCURRED WITH THE SPRINTER LEGEND DEVICE FOLLOWING BALLOON INFLATION. THERE WAS AN ISSUE REMOVING THE BALLOON FROM THE CATHETER AS IT WAS TIGHT. THE PHYSICIAN INDICATED THAT THE CO-PILOT CLAMPED DOWN ON THE SPRINTER LEGEND AND STRETCHED THE CATHETER.  NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13277994 ↗
• MalfunctionNov 8, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND BALLOON CATHETER TO TREAT A LESION IN THE RCA. THERE WAS NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP AND THE PACKAGING AND PROTECTIVE SHEATH AND STYLETTE LOOKED NORMAL. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WAS INFLATED TO 14 ATMS. THE INDEFLATOR SHOWED 14 ATM BUT SLOWLY LOST PRESSURE. THERE WAS NO CONTRAST NOTED IN THE VESSEL. THE BALLOON WAS REMOVED FROM THE PATIENT AND A SYRINGE OF SALINE WAS ATTACHED AND HAND PUSHED. A PINPOINT STEAM OF SALINE WAS NOTED TO COME OUT OF THE BALLOON. THE LEAK WAS LOCATED NEAR THE SHAFT OF THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770968 ↗
• MalfunctionSep 20, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS INTENDED TO USE ONE SPRINTER LEGEND DEVICE TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO DAMAGE WAS NOTED TO THE PACKAGING, NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING BALLOON INFLATION AT 10 ATM. ONE INFLATION HAD BEEN APPLIED PRIOR TO THE ISSUE BEING IDENTIFIED. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES CALCIUM IN THE LESION CAUSED A TEAR IN THE BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495117 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE SPRINTER LEGEND RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A 75% CALCIFIED, NON TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. IT WAS DIFFICULT TO REMOVE THE PROTECTIVE SHEATH, THERE WAS NO DIFFICULTY REMOVING THE PACKAGING STYLETTE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE TRAVERSE GUIDEWIRE WAS 300CM. THE GUIDEWIRE WAS USED SUCCESSFULLY WITH OTHER DEVICES PRIOR TO THE DIFFICULTY OCCURRING. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE WIRE ENTRY PORT. THERE WERE NO DIFFICULTIES NOTED WHEN LOADING THE DEVICE ONTO THE GUIDEWIRE. IT WAS REPORTED THAT THERE WAS POOR GUIDE WIRE MOVEMENT DURING THE PROCEDURE. IT WAS ATTEMPTED TO RE-POSITION THE WIRE AND BRING IT BACK TO THE BALLOON. IT WAS STATED THAT THE TRAVERSE WIRE GOT STUCK IN THE BALLOON. THE WIRE AND THE BALLOON WERE THEN REMOVED AS ONE UNIT. IT WAS INDICATED THAT THE SPRINTER LEGEND DEVICE LOOKED DAMAGED DUE TO THE ATTEMPTS TO REMOVE THE WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11818399 ↗
• InjuryMay 4, 2021Deflation Problem; Deflation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE DEVICE MOVED IN THE LESION WHILE INFLATED. THE DEVICE WAS PULLED OUT. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY. THE EVENT RESULTED IN STELEVATION AND THE PATIENT IS IN HOSPITAL ON ECMO.

  Patient problems: Non specific EKG/ECG Changes; Unspecified Tissue Injury

  MAUDE report 11768456 ↗

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