RUNTHROUGH 25-1013Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04987350703583), received between Aug 15, 2019 and Nov 27, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A 7X150MM SMART VASCULAR STENT (C07150ML LOT 18328912) WAS DEPLOYED OVER A TERUMO RUNTHROUGH 0.014" WIRE (MANUFACTURER CODE 25-1013, LOT 240201Y) IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING DEPLOYMENT, THE DISTAL END OF THE WIRE BECAME TRAPPED BEHIND THE STENT. IN ATTEMPTING TO REMOVE THE WIRE FROM THE STENT, THERE WAS DAMAGE TO THE DISTAL EDGE OF THE SMART STENT. MULTIPLE ATTEMPTS WERE MADE TO DISENGAGE THE WIRE AND REMOVE IT. ATTEMPTS WERE ALSO MADE TO RE-CROSS AND BALLOON THE DISTAL EDGE OF THE STENT, WHICH RESULTED IN FURTHER DAMAGE TO THE STENT. THE PATIENT WAS ULTIMATELY TRANSFERRED TO AN ACUTE CARE HOSPITAL FOR VASCULAR SURGERY. THE ACCESS SITES WERE: RIGHT COMMON FEMORAL ARTERY; LEFT ANTERIOR TIBIAL ARTERY. SHEATHS USED: RFA: 6F 45CM TERUMO DESTINATION SHEATH LEFT ANTERIOR TIBIAL ARTERY: 6F CORDIS RAIN SHEATH OTHER WIRES USED DURING THE PROCEDURE: CORDIS AQUATRACK ((B)(6)) TERUMO GLIDEWIRE ADVANTAGE .035" TERUMO GLIDEWIRE ADVANTAGE .014". LESION INFORMATION: TOTAL OCCLUSION OF LEFT SUPERFICIAL FEMORAL ARTERY FROM OSTIAL TO POPLITEAL. PREVIOUSLY TREATED. PATIENT DISCONTINUED MEDICATIONS. MODERATE CALCIFICATION LESION TREATED WI

  Patient problems: Foreign Body In Patient

  MAUDE report 20794073 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT A 7X150MM SMART VASCULAR STENT (C07150ML LOT 18328912) WAS DEPLOYED OVER A TERUMO RUNTHROUGH 0.014" WIRE (MANUFACTURER CODE 25-1013, LOT 240201Y) IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING DEPLOYMENT, THE DISTAL END OF THE WIRE BECAME TRAPPED BEHIND THE STENT. IN ATTEMPTING TO REMOVE THE WIRE FROM THE STENT, THERE WAS DAMAGE TO THE DISTAL EDGE OF THE SMART STENT. MULTIPLE ATTEMPTS WERE MADE TO DISENGAGE THE WIRE AND REMOVE IT. ATTEMPTS WERE ALSO MADE TO RE-CROSS AND BALLOON THE DISTAL EDGE OF THE STENT, WHICH RESULTED IN FURTHER DAMAGE TO THE STENT. THE PATIENT WAS ULTIMATELY TRANSFERRED TO AN ACUTE CARE HOSPITAL FOR VASCULAR SURGERY. THE ACCESS SITES WERE: RIGHT COMMON FEMORAL ARTERY; LEFT ANTERIOR TIBIAL ARTERY. SHEATHS USED: RFA: 6F 45CM TERUMO DESTINATION SHEATH LEFT ANTERIOR TIBIAL ARTERY: 6F CORDIS RAIN SHEATH OTHER WIRES USED DURING THE PROCEDURE: CORDIS AQUATRACK ((B)(6)) TERUMO GLIDEWIRE ADVANTAGE .035" TERUMO GLIDEWIRE ADVANTAGE .014". LESION INFORMATION: TOTAL OCCLUSION OF LEFT SUPERFICIAL FEMORAL ARTERY FROM OSTIAL TO POPLITEAL. PREVIOUSLY TREATED. PATIENT DISCONTINUED MEDICATIONS. MODERATE CALCIFICATION LESION TREATED WI

  Patient problems: Foreign Body In Patient

  MAUDE report 20793899 ↗
• InjuryJul 22, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE DEVICE INVOLVED WAS BEING USED TO CROSS OVER SEVERELY DISEASED CIRCUMFLEX ARTERY. THE GUIDEWIRE TIP SUDDENLY BROKE OFF FROM THE SHAFT. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. PATIENT CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS A SUCCESS. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17375370 ↗
• InjuryJul 22, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE DEVICE INVOLVED WAS BEING USED TO CROSS OVER SEVERELY DISEASED CIRCUMFLEX ARTERY. THE GUIDEWIRE TIP SUDDENLY BROKE OFF FROM THE SHAFT. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. PATIENT CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS A SUCCESS. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17375364 ↗
• InjuryNov 15, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 07DECEMBER2021. THE LESION HAD CALCIFICATION AND TORTUOSITY WHEN THE ACTUAL DEVICE WAS USED IN THE LESION. THE DEVICE WAS BEING USED ALONE WHEN THE EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12812128 ↗
• InjuryNov 15, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THEY HAD A ST-ELEVATED MYOCARDIAL INFRACTION (STEMI) PATIENT THAT HAD A BALLOON/STENT IN THE RIGHT CORONARY ARTERY (RCA). UPON PULLING THE RTNS OUT THE RADIOPAQUE TIP WAS DISLODGED AND HAD TO BE SNARED OUT. THERE WERE NO PATIENT COMPLICATIONS OR ISSUES REPORTED. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 26OCT2021. CONTRAST WAS RAN POST SNARE TO CONFIRM THERE WERE NO PARTICLES LEFT IN THE PATIENT. THERE WAS CALCIFICATION AND TORTUOSITY PRESENT, THEY HAD TO BALLOON AND STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12812100 ↗
• InjuryAug 15, 2019Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 02AUG2019. AFTER REVIEWING THE IMAGES (LAB MANAGER AND COMPANY REPRESENTATIVE), IT WAS BELIEVED THAT ONLY THE FIRST WIRE BROKE INTO TWO PARTS. THE PROGRESSION OF THE PROCEDURE: ROTOBLADER (BOSTON SCIENTIFIC) THE LEFT MAIN, THERE WAS A STENOSED STENT IN THE RAMUS, ADVANCED RUNTHROUGH (LOT 170420) THROUGH STENT, LASERED (PHILIPS), WIRE WAS PROLAPSED, ANGIOPLASTY OF STENT, WHEN WIRE WAS REMOVED, DISTAL PART OF WIRE REMAINED (APPROXIMATELY 26MM), IN THE IMAGES, A SECOND RADIOPAQUE PORTION OF THE WIRE DISTAL TO THE STENT; HOWEVER, PROXIMAL TO THE LEFT BEHIND WIRE WAS SEEN. THE PHYSICIAN ADVANCED A SECOND RUNTHROUGH WIRE AND ATTEMPTED TO SNARE; UNSUCCESSFULLY. WHEN REMOVING THE SECOND WIRE, THEY THOUGHT A 10MM PORTION BROKE OFF; HOWEVER, THEY NOW THINK IT WAS ALSO PART OF THE FIRST WIRE. THE PATIENT CONDITION WAS CONTINUING TO BE STABLE WITH WIRE FRAGMENTS REMAINING IMPLANTED; THE LOCATION OF THE WIRE FRAGMENTS IS IN THE PATIENT'S RAMUS. APPROXIMATE SIZE OF WIRE FRAGMENTS - DISTAL 26MM, PROXIMAL SEGMENT 6MM. THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION TAKEN PLACE. ADDITIONAL INFORMATION WAS RECEIVED ON 26SEP2019. THE PATIENT'S CONDITION CO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8896319 ↗
• InjuryAug 15, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A COMPLEX CORONARY, INVOLVING IN-STENT RESTENOSIS AND LASER ATHERECTOMY. HE USED 2 RUNTHROUGH WIRES AND BOTH HAD PART OF THE DISTAL WIRE BREAK OFF AND STAY IN THE PATIENT. THEY TRIED TO SNARE THE PIECES UNSUCCESSFULLY. THE PATIENT CONDITION WAS STABLE AT THE END OF THE PROCEDURE. THERE WAS NO SURGERY; HOWEVER, THEY WERE UNABLE TO REMOVE THE WIRE WITH SNARE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8896316 ↗
• InjuryAug 15, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A COMPLEX CORONARY, INVOLVING IN-STENT RESTENOSIS AND LASER ATHERECTOMY. HE USED 2 RUNTHROUGH WIRES AND BOTH HAD PART OF THE DISTAL WIRE BREAK OFF AND STAY IN THE PATIENT. THEY TRIED TO SNARE THE PIECES UNSUCCESSFULLY. THE PATIENT CONDITION WAS STABLE AT THE END OF THE PROCEDURE. THERE WAS NO SURGERY; HOWEVER, THEY WERE UNABLE TO REMOVE THE WIRE WITH SNARE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8896315 ↗
• InjuryAug 15, 2019Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 02AUG2019. AFTER REVIEWING THE IMAGES (LAB MANAGER AND COMPANY REPRESENTATIVE), IT WAS BELIEVED THAT ONLY THE FIRST WIRE BROKE INTO TWO PARTS. THE PROGRESSION OF THE PROCEDURE: ROTOBLADER (BOSTON SCIENTIFIC) THE LEFT MAIN, THERE WAS A STENOSED STENT IN THE RAMUS, ADVANCED RUNTHROUGH (LOT 170420) THROUGH STENT, LASERED (PHILIPS), WIRE WAS PROLAPSED, ANGIOPLASTY OF STENT, WHEN WIRE WAS REMOVED, DISTAL PART OF WIRE REMAINED (APPROXIMATELY 26MM), IN THE IMAGES, A SECOND RADIOPAQUE PORTION OF THE WIRE DISTAL TO THE STENT; HOWEVER, PROXIMAL TO THE LEFT BEHIND WIRE WAS SEEN. THE PHYSICIAN ADVANCED A SECOND RUNTHROUGH WIRE AND ATTEMPTED TO SNARE; UNSUCCESSFULLY. WHEN REMOVING THE SECOND WIRE, THEY THOUGHT A 10MM PORTION BROKE OFF; HOWEVER, THEY NOW THINK IT WAS ALSO PART OF THE FIRST WIRE. THE PATIENT CONDITION WAS CONTINUING TO BE STABLE WITH WIRE FRAGMENTS REMAINING IMPLANTED; THE LOCATION OF THE WIRE FRAGMENTS IS IN THE PATIENT'S RAMUS. APPROXIMATE SIZE OF WIRE FRAGMENTS - DISTAL 26MM, PROXIMAL SEGMENT 6MM. THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION TAKEN PLACE. ADDITIONAL INFORMATION WAS RECEIVED ON 26SEP2019. THE PATIENT'S CONDITION CO

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8896314 ↗