TrailBlazer™ SC-035-135 (UDI 00763000104818)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000104818), received between Jul 16, 2019 and May 1, 2025 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 reports).

1 other recall cover devices cleared under the same FDA submission (K092299); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Difficult to Advance; Material Deformation; Positioning Problem; Difficult to Advance; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PS SC-035-135 TRAILBLAZER, SEVERAL ISSUES WERE ENCOUNTERED. THE PATIENT'S ANATOMY EXHIBITED A SEVERE DEGREE OF TORTUOSITY, AND ABNORMALITIES WERE NOTED SPECIFICALLY WHEN CROSSING THE AORTA BIFURCATION. MODERATE RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. THE DEVICE WAS UNABLE TO CROSS THE LESION. TRACKING DIFFICULTIES WERE ALSO NOTED DURING THE SECOND ADVANCEMENT DUE TO A TIGHT BIFURCATION AND THE PATIENT BEING VERY SMALL. IT WAS ALSO REPORTED THAT THE PHYSICIAN'S WIRE PUNCTURED THE TRAILBLAZER WHILE CROSSING THE BIFURCATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WHICH WAS NOT A MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941157 ↗
• MalfunctionNov 21, 2024Material Deformation; Material Deformation

  A TRAILBLAZER SUPPORT CATHETER WAS INTENDED TO BE USED DURING TREATMENT OF A LESION IN THE PROXIMAL REGION OF THE RIGHT COMMON ILIAC ARTERY. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY AND THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THERE WAS A HOLE IN THE MID PORTION OF THE CATHETER. THE GUIDEWIRE EXITED THE HOLE. NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. ANOTHER TRAILBLAZER WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742839 ↗
• MalfunctionJan 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A TRAILBLAZER TO TREAT A PLAQUE LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY, TIBIAL/POPLITEAL TRUNK. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS 40%. A 5FR 10CM TERUMO SHEATH WAS USED. A .035 ADVANTAGE WIRE WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE CATHETER BROKE OFF WHILE REMOVING IT FORM THE BODY. IT WAS STILL ATTACHED TO THE WIRE. IT DID NOT BREAK IN MULTIPLE SEGMENTS. ALL SEGMENTS/FRAGMENTS RETRIEVED. THE PHYSICIAN WAS ABLE TO PULL THE WIRE BACK TO RETRIEVE THE REST OF THE CATHETER TIP.  A 6FR 45CM DESTINATION SHEATH WAS PUT IN OVER THE ADVANTAGE WIRE AND BELOW THE KNEE WAS BALLOONED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579778 ↗
• InjuryOct 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS BEING USED DURING TREATMENT OF A CALCIFIED PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014 NON MEDTRONIC GUIDEWIRE WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED WHILE TRYING TO CROSS CTO SEVERAL TIMES BY TWISTING WIRE ENDED UP CORK SCREWING INSIDE THE TRAILBLAZER AND GETTING STUCK INSIDE OF IT. THE PHYSICIAN USED A LOT OF FORCE TO GET THE WIRE OUT OF TRAILBLAZER. UPON REMOVAL OF TRAILBLAZER AND WIRE THE PHYSICIAN NOTICED THAT 3 DOTS WERE STILL VISIBLE IN THE VESSEL. IT WAS DETERMINED THAT THE DISTAL END OF TRAILBLAZER BROKE OFF INTO THE VESSEL. THIS PIECE WAS SUCCESSFULLY REMOVED USING A SNARE. NO DAMAGE NOTED TO PATIENT. ONCE RETRIEVED THE PHYSICIAN ELECTED TO TERMINATE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919612 ↗
• MalfunctionApr 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS BEING USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE TIP BROKE OFF DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16729954 ↗
• InjuryMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS BEING USED DURING TREATMENT OF A PLAQUE LESION WITH 80% STENOSIS IN THE MID ILIAC ARTERY. THE DEGREE OR TORTUOSITY AND CALCIFICATION WAS MODERATE. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED THE CATHETER BROKE IN TWO SEGMENTS IN THE BODY OF THE CATHETER. A SNARE WAS USED TO REMOVE THE FRAGMENTED PIECE FROM THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16641534 ↗
• InjuryOct 17, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  A PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER CATHETER DURING TREATMENT OF CALCIFIED AND PLAQUE LESION WITH 60% STENOSIS IN THE DISTAL RIGHT ILIAC ARTERY.  THE ARTERY HAD A DIAMETER OF 7MM WITH SEVERE TORTUOSITY AND MODERATE CALCIFICATION. A 7FR NON MDT SHEATH AND 0.035" NON-MDT GUIDEWIRE WERE USED. THE TRAILBLAZER BROKE DURING PREPARATION ON THE STERILE TABLE AND A SECOND TRAILBLAZER WAS THEN PREPPED AND PUT INTO THE BODY THROUGH THE SHEATH AND UP AND OVER THE AORTIC BIFURCATION AND BROKE AT THAT POINT. BOTH BREAKS OF THE TRAILBLAZER OCCURRED AT THE PROXIMAL MARKER WHERE THE CATHETER COMPLETELY BROKE AND SHEARED OFF. DURING THE FIRST TRAILBLAZER INCIDENT THE SCRUB WAS ATTEMPTING TO PREP THE TRAILBLAZER CATHETER AND COULD NOT FLUSH THE CATHETER AT WHICH POINT THEY FLUSHED HARDER AND THE CATHETER TIP AT THAT PROXIMAL MARKER BROKE COMPLETELY OFF. THERE MAY HAVE BEEN SOME MANUAL MANIPULATION OF THE CATHETER AFTER THE ATTEMPT TO FLUSH DID NOT OCCUR AND AT WHICH POINT THE CATHETER BROKE ON THE TABLE. THE SECOND TRAILBLAZER THAT WAS SUBSEQUENT LY OPENED AND FLUSHED WITH NO INCIDENT WAS PUT INTO THE BODY INTO THE COMMON FEMORAL SHEATH IN A RETROGRADE FASHION AND FOLLOWED THE 035 WIRE AR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614163 ↗
• MalfunctionOct 7, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A TRAILBLAZER SUPPORT CATHETER WAS USED DURING A PROCEDURE FOR TREATMENT OF A 150MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE TORTUOSITY AND CALCIFICATION. IT WAS REPORTED UPON REMOVING THE TRAILBLAZER FROM THE PATIENT THERE WAS A TREMENDOUS AMOUNT OF RESISTANCE IN REMOVING THE CATHETER. THE DEVICE SEPARATED ON THE WIRE OUTSIDE THE SHEATH UPON RETRACTION WITH DETACHMENT OCCURRING. A QUCIK CROSS WAS THEN USED WITHOUT ISSUE OVER THE SAME WIRE. THE SURGERY WAS COMPLETED WITH A HAWK AND DCB INTERVENTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15560639 ↗
• InjuryOct 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER GUIDE CATHETER DURING PROCEDURE TO TREAT A LESION IN THE LEFT FEMORAL SUPERFICIAL ARTERY WITH SEVERE CALCIFICATION. IT WAS REPORTED THAT SEVERE RESISTANCE WAS NOTED DURING ADVANCEMENT. IT WAS REPORTED THAT THE CATHETER BROKE IN THE PATIENTS LEFT FEMORAL SUPERFICIAL ARTERY DURING THE NAVIGATION, 8/10 CM FROM ITS END, THE DISTAL PART OF THE CATHETER (APPROXIMATELY 4 CM) DETACHED, AND REMAINS IN THE PATIENT'S LEFT FEMORAL SUPERFICIAL ARTERY WITH THE IMPOSSIBILITY OF RETRIEVING IT. PART OF THE CATHETER IS STILL INSIDE THE ARTERY WITH THE RISK OF LEG AMPUTATION.

  Patient problems: Insufficient Information

  MAUDE report 15551299 ↗
• InjuryMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER ALONG WITH A NON-MEDTRONIC 6FR X 45CM SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL, MID AND DISTAL COMMON ILIAC ARTERY WITH 70% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL WAS NOT PRE OR POST DILATED. IFU WAS FOLLOWED. BROKEN CATHETER OCCURRED. IT WAS REPORTED THAT THE CATHETER WAS BEING USED IN PLACE OF THE SHEATH DILATOR TO CROSS FROM THE RIGHT ILIAC INTO THE LEFT. THE STIFF-ANGLED NON-MEDTRONIC WIRE WAS REMOVED TO REPLACE WITH A STIFFER NON-MEDTRONIC WIRE. AT THIS POINT, THE WIRE WAS NOT ABLE TO PASS THROUGH THE CATHETER, SUBSTANTIAL FORCE WAS NEEDED WHICH RESULTED IN THE CATHETER BREAKING AT THE MOST PROXIMAL MARKER. THIS RESULTED IN THE LAST 10CM OF THE TRAILBLAZER REMAINING IN PATIENT. THE CATHETER SEGMENT OR FRAGMENTS WAS NOT STUCK ON THE GUIDEWIRE. THE SEGMENTS/FRAGMENTS OF THE CATHETER WERE NOT RETRIEVED. THE LEFT COMMON FEMORAL WAS ACCESSED AND A 10MM GOOSENECK SNARE WAS USED TO ATTEMPT RETRIEVAL OF THE CATHETER TIP. WHEN THIS WAS UNSUCCESSFUL, IT WAS DECIDED THAT THE BEST COURSE OF ACTION WAS TO STENT THE CATHETER IN PLACE WITH A 8X100MM EVERFLEX. SUBSEQUENTLY ANGIOGRAPHY DEMONSTRA

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

  MAUDE report 13857632 ↗
• InjuryOct 12, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE TRAILBLAZER SUPPORT CATHETER DURING PROCEDURE TO TREAT SEVERELY CALCIFIED FIBROUS PLAQUE IN THE DISTAL LEFT COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA). VESSEL EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) AND HAD MODERATE TORTUOSITY. A NON MEDTRONIC 5FR X 11CM SHEATH WAS USED AND A WHOLEY 0.035'' GUIDEWIRE. THE VESSEL WAS NEITHER PRE NOR POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE CATHETER BROKE. IT DID NOT BREAK IN MULTIPLE SEGMENTS. THE WHOLEY WIRE AND TRAILBLAZER WERE OVER THE AORTIC BIFURCATION. AS THE TRAILBLAZER WAS BEING WALKED BACK TO LEAVE THE WIRE IN FOR PLACEMENT OF THE CROSSOVER SHEATH THE PHYSICIAN FELT RESISTANCE AND NOTICED THAT THE DISTAL PORTION OF THE TRAILBLAZER WAS ON THE WIRE AND NOT MOVING WITH THE REST OF THE CATHETER. THE CATHETER SEGMENT WAS STUCK ON THE GUIDEWIRE. A SNARE WAS THREADED OVER THE WIRE UNTIL NEAR THE CATHETER. IT WAS THREADED OVER THE CATHETER AND TIGHTENED. SNARE, CATHETER AND WIRE WERE THEN REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED BY REMOVING THE WIRE AND BROKEN CATHETER AND USING A NEW TRAILBLAZER WITH NO FURTHER ISSUES. NO ISSUE WITH WHOLEY WIRE USED. NO VESSEL DAMAGE NO

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12615215 ↗
• InjuryApr 14, 2021Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE TRAILBLAZER SUPPORT CATHETER ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID COMMON ILIAC ARTERY (CIA) WITH 20% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS WITH 8MM DIAMETER. THE VESSEL WAS NOT PRE OR POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT ONE SEGMENT OF THE CATHETER BROKE WITH THE SEGMENT RETRIEVED WITH SNARE. THE BROKEN PART OF THE TRAILBLAZER WAS RETRIEVED FROM PATIENT BODY SAFELY. PHYSICIAN PROCEEDED TO TREAT. IT WAS REPORTED THAT ACCESS WAS AT RIGHT COMMON FEMORAL. PHYSICIAN WAS USING STIFF GLIDEWIRE AND NON-MEDTRONIC FLUSH CATHETER TO GO TO CONTRALATERAL SIDE-LEFT. ONCE THE WIRE WENT DOWN INTO THE LEFT COMMON FEMORAL, PHYSICIAN REMOVED THE FLUSH CATHETER AND ADVANCED 0.035"X135 TRAILBLAZER OVER THE WIRE. ADVANCING OVER ILIAC BIFURCATION, THERE WAS RESISTANCE FELT. ONCE TRAILBLAZER WAS ADVANCED INTO EXTERNAL/ILIAC COMMON FEMORAL, THE CATHETER WOULD NOT TRACK, THE PHYSICIAN TRIED TO REMOVE TRAILBLAZER CATHETER LEAVING WIRE IN ITS POSITION. WHEN REMOVING TRAILBLAZER, PHYSICIAN FELT SNAP AND WHEN REMOVED, NOTICED NOT THE WHOLE CATHETER WAS REMOVED. PHYSICI

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11662830 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF TRAILBLAZER SUPPORT CATHETER THAT THE TIP DETACHED FROM THE PROBE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10552124 ↗
• InjuryAug 28, 2020Fracture; Difficult to Remove; Detachment of Device or Device Component; Fracture; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A TRAILBLAZER SUPPORT CATHETER DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S PROXIMAL LEFT COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY. SEVERE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED. IT IS REPORTED THE CATHETER BROKE WHILE REMOVING THE DEVICE OVER THE COMMON ILIAC BIFURCATION. THE CATHETER FRAGMENTS REMAINED STUCK ON THE GUIDEWIRE. A 10MM GOOSENECK SNARE WAS USED TO RETRIEVE THE BROKEN CATHETER. WHEN THE TRAILBLAZER WAS REMOVED FROM THE PATIENT, A LONG SHEATH WAS USED TO CROSSOVER BIFURCATION AND TREAT THE INTENDED VESSEL. NO FURTHER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464415 ↗
• MalfunctionApr 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF TRAILBLAZER, THE PROCEDURAL CATHETER BROKE OFF IN THE PATIENT¿S VASCULATURE. THE FLOATING PIECE OF CATHETER WAS RETRIEVED BY PHYSICIAN.

  Patient problems: No Information

  MAUDE report 10005784 ↗
• MalfunctionApr 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF TRAILBLAZER, THE PROCEDURAL CATHETER BROKE OFF IN THE PATIENT¿S VASCULATURE. THE FLOATING PIECE OF CATHETER WAS RETRIEVED BY PHYSICIAN.

  Patient problems: No Information

  MAUDE report 10005745 ↗
• InjuryFeb 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A TRAILBLAZER GUIDE CATHETER ALONG WITH NON MEDTRONIC 6FR SHEATH, .035" GUIDE WIRE AND 6MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A PLAQUE LESION IN THE RIGHT PROXIMAL COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). IT WAS REPORTED THAT DURING PROCEDURE AND WHILE ATTEMPTING TO PASS THE SPIDER FX, PHYSICIAN NOTICED CATHETER SEPARATION AT THE PROXIMAL MARKER. A GOOSENECK SNARE WAS USED TO RETRIEVE DETACHED COMPONENT. ALL FRAGMENTS OF THE CATHETER WERE RETRIEVED. A NEW CATHETER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 9664164 ↗
• InjuryJan 13, 2020Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking; Difficult to Insert; Difficult to Remove; Detachment of Device or Device Component; Physical Resistance/Sticking

  PHYSICIAN USED A TRAILBLAZER CATHETER AS PART OF A PROCEDURE ON THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE MID, CALCIFIED LESION HAD SEVERE TORUOSITY AND SEVERE CALCIFICATION. THE IFU WAS FOLLOWED. RESISTANCE WAS FELT DURING WITHDRAWAL OF THE DEVICE. IT WAS REPORTED THAT UPON REMOVAL OF THE DEVICE, THE TIP OF THE TRAILBLAZER DETACHED. A SNARE WAS USED TO SUCCESSFULLY REMOVED THE DETACHED PORTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAILBLAZER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580155 ↗
• MalfunctionOct 9, 2019Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  PHYSICIAN USED A TRAILBLAZER DEVICE DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S DISTAL AORTA. MODERATE CALCIFICATION AND SEVERE TORTUOSITY ARE REPORTED. NO STENOSIS REPORTED. IFU WAS FOLLOWED. IT IS REPORTED A KINK OCCURRED DISTAL ON CATHETER DURING INITIAL ADVANCEMENT OF THE DEVICE. THE CATHETER WAS NOT GRIPPED AT THE DISTAL TIP. MINIMAL RESISTANCE WAS EXPERIENCED DURING WITHDRAWAL, BUT REMOVED WITHOUT ISSUE. A DIFFERENT CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION, IT WAS NOTED THAT THE SHAFT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171755 ↗
• MalfunctionJul 16, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING AN EVERCROSS PTA CATHETER WITH A TRAILBLAZER SUPPORT CATHETER TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE MID PROXIMAL COMMON ILIAC ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THEIR TRAY/HOOP. THE DEVICES WERE PREPPED PER IFU WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. MINIMAL RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT OF THE EVERCROSS. THE EVERCROSS WAS INFLATED TO 8ATM WITH A NON-MEDTRONIC (BOSTON SCIENTIFIC) INFLATION DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, BUT RESISTANCE WAS ENCOUNTERED BUT NO EXCESSIVE FORCE USED ON ADVANCING THE DEVICE TO THE TARGET LESION. THE EVERCROSS IS REPORTED TO HAVE BURST. SEVERE RESISTANCE WAS ENCOUNTERED DURING REMOVAL. THE 2 DEVICES WERE REMOVED TOGETHER AND THEN IT WAS NOTED THAT THE TRAILBLAZER DELIVERY CATHETER WAS DAMAGED. THE STRUCTURAL INTEGRITY OF THE TRAILBLAZER WAS REPORTED TO BE COMPROMISED INTERNALLY. ALL FRAGMENTS OF THE BURST BALLOON WERE RETRIEVED. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE AT A LATER DATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8794221 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092299. One submission often covers many models, so check the product and lot details in each record.

• Z-0497-2010 · Nov 6, 2009 · Terminated
  TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-