RUNTHROUGH 25-3011Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04987350720986), received between Mar 16, 2018 and Mar 6, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE DISTAL WIRE TIP SEPARATED AWAY FROM THE MAIN BODY OF THE WIRE DURING A CORONARY INTERVENTION. AS A BAILOUT THE PHYSICIAN CHOSE TO STENT THE WIRE UP AGAINST THE VESSEL WALL. OUTCOME FOR THE PATIENT WAS SATISFACTORY. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19FEB2025: THE PATIENT'S ANATOMY WAS PARTICULARLY TORTUOUS AT THE POINT OF SEPARATION. AN ACUTE ANGLE/TAKEOFF FROM THE PROXIMAL LAD INTO THE OSTIUM OF THE CIRCUMFLEX. STENTS WERE DEPLOYED IN THE CIRCUMFLEX, CIRCUMFLEX OSTIUM, AND PROXIMAL LAD. IT WAS NOTED THAT THE STENTS COVERED THE WIRE SEGMENT IN QUESTION PRIOR TO WIRE REMOVAL. APPROXIMATELY 3-4CM; ADDITIONALLY, THE WIRE SEGMENT THAT SEPARATED, WAS THE ESTIMATED LENGTH OF THE RADIOPAQUE MARKER. THE WIRE WAS STENTED PROXIMAL, AND OSTIUM OF CIRCUMFLEX AND PROXIMAL LAD. THE PATIENT WAS STABLE. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21536921 ↗
• InjuryMar 6, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DISTAL WIRE TIP SEPARATED AWAY FROM THE MAIN BODY OF THE WIRE DURING A CORONARY INTERVENTION. AS A BAILOUT THE PHYSICIAN CHOSE TO STENT THE WIRE UP AGAINST THE VESSEL WALL. OUTCOME FOR THE PATIENT WAS SATISFACTORY. NO BLOOD LOSS WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19FEB2025: THE PATIENT'S ANATOMY WAS PARTICULARLY TORTUOUS AT THE POINT OF SEPARATION. AN ACUTE ANGLE/TAKEOFF FROM THE PROXIMAL LAD INTO THE OSTIUM OF THE CIRCUMFLEX. STENTS WERE DEPLOYED IN THE CIRCUMFLEX, CIRCUMFLEX OSTIUM, AND PROXIMAL LAD. IT WAS NOTED THAT THE STENTS COVERED THE WIRE SEGMENT IN QUESTION PRIOR TO WIRE REMOVAL. APPROXIMATELY 3-4CM; ADDITIONALLY, THE WIRE SEGMENT THAT SEPARATED, WAS THE ESTIMATED LENGTH OF THE RADIOPAQUE MARKER. THE WIRE WAS STENTED PROXIMAL, AND OSTIUM OF CIRCUMFLEX AND PROXIMAL LAD. THE PATIENT WAS STABLE. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21536908 ↗
• InjuryJun 24, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RUNTHROUGH DEVICE WAS USED DURING THE PROCEDURE AND SEPARATED ON WITHDRAWAL. THE PATIENT'S CONDITION WAS REPORTED GOOD AND WAS DOING FINE. THE PROCEDURE OUTCOME WAS GOOD. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 10JUN2020. THERE WAS NO PART LEFT IN THE PATIENT. THE PROCEDURE BEING PERFORMED WAS A CORONARY ANGIOPLASTY.

  Patient problems: Blood Loss

  MAUDE report 10189414 ↗
• InjuryJun 24, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RUNTHROUGH DEVICE WAS USED DURING THE PROCEDURE AND SEPARATED ON WITHDRAWAL. THE PATIENT'S CONDITION WAS REPORTED GOOD AND WAS DOING FINE. THE PROCEDURE OUTCOME WAS GOOD. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 10JUN2020. THERE WAS NO PART LEFT IN THE PATIENT. THE PROCEDURE BEING PERFORMED WAS A CORONARY ANGIOPLASTY.

  Patient problems: Blood Loss

  MAUDE report 10189412 ↗
• InjurySep 24, 2019Break; Difficult to Advance; Break; Difficult to Advance

  THE USER FACILITY REPORTED THAT WHILE APPROACHING A CORONARY, IN-STENT RESTENOSIS, IN THE LEFT MAIN, THE 180 CM LENGTH RUN THROUGH HYPER COAT BECAME CAUGHT/JAILED BEHIND THE STENT STRUT AS THE WIRE WAS ADVANCED; SUBSEQUENTLY THE WIRE SEPARATED APPROXIMATELY 10 CM FROM THE DISTAL TIP OF THE WIRE. THE REMAINDER OF THE PROXIMAL ASPECT OF THE WIRE WAS REMOVED; HOWEVER, THE DISTAL SEGMENT OF THE WIRE REMAINS LODGED BEHIND THE STENT STRUT AND LEFT MAIN VESSEL WALL. ADDITIONALLY, THE REMAINING PROXIMAL SEGMENT OF THE WIRE IS CIRCLING THE OPPOSING, CONTRALATERAL AORTIC ROOT. A SNARE WAS USED TO SNARE THE WIRE AND RETRIEVE WITHOUT SUCCESS. THE PATIENT WAS TURNED DOWN FOR SURGERY. ANOTHER ATTEMPT TO RETRIEVE THE WIRE MAY BE MADE ON A LATER DATE. BLOOD LOSS WAS LESS THAN 250 CC. THE PATIENT'S CONDITION WAS STABLE. CALCIFIED VASCULATURE, PREVIOUS BY-PASS PATIENT, LEFT MAIN IN-STENT RESTENOSIS. THE PROCEDURE OUTCOME WAS UNSATISFACTORY. ADDITIONAL INFORMATION WAS RECEIVED ON 09SEP2019. THE PROCEDURE TO REMOVE THE WIRE WAS PERFORMED ON (B)(6) 2019, WITH PARTIAL RETRIEVAL OF THE SPRING COIL SEGMENT OF THE WIRE. THE REMAINING DISTAL SEGMENT OF THE WIRE WOULD NOT RELEASE FROM THE STENT STRUT. THE AT

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 9110972 ↗
• InjurySep 24, 2019Break; Difficult to Advance; Break; Difficult to Advance

  THE USER FACILITY REPORTED THAT WHILE APPROACHING A CORONARY, IN-STENT RESTENOSIS, IN THE LEFT MAIN, THE 180 CM LENGTH RUNTHROUGH HYPERCOAT BECAME CAUGHT/JAILED BEHIND THE STENT STRUT AS THE WIRE WAS ADVANCED; SUBSEQUENTLY THE WIRE SEPARATED APPROXIMATELY 10CM FROM THE DISTAL TIP OF THE WIRE. THE REMAINDER OF THE PROXIMAL ASPECT OF THE WIRE WAS REMOVED; HOWEVER, THE DISTAL SEGMENT OF THE WIRE REMAINS LODGED BEHIND THE STENT STRUT AND LEFT MAIN VESSEL WALL. ADDITIONALLY, THE REMAINING PROXIMAL SEGMENT OF THE WIRE IS CIRCLING THE OPPOSING, CONTRALATERAL AORTIC ROOT. A SNARE WAS USED TO SNARE THE WIRE AND RETRIEVE WITHOUT SUCCESS. THE PATIENT WAS TURNED DOWN FOR SURGERY. ANOTHER ATTEMPT TO RETRIEVE THE WIRE MAY BE MADE ON A LATER DATE. BLOOD LOSS WAS LESS THAN 250 CC. THE PATIENT'S CONDITION WAS STABLE. CALCIFIED VASCULATURE, PREVIOUS BY-PASS PATIENT, LEFT MAIN IN-STENT RESTENOSIS. THE PROCEDURE OUTCOME WAS UNSATISFACTORY. ADDITIONAL INFORMATION WAS RECEIVED ON 09SEP2019. THE PROCEDURE TO REMOVE THE WIRE WAS PERFORMED ON (B)(6) 2019, WITH PARTIAL RETRIEVAL OF THE SPRING COIL SEGMENT OF THE WIRE. THE REMAINING DISTAL SEGMENT OF THE WIRE WOULD NOT RELEASE FROM THE STENT STRUT. THE ATTEN

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 9110949 ↗
• InjuryDec 28, 2018Break; Break

  TERUMO MEDICAL RECEIVED "AN" USER FACILITY MEDWATCH REPORT # (B)(4) ON DECEMBER 10, 2018. THE EVENT DESCRIPTION STATES THE FOLLOWING: THE USER FACILITY REPORTED THAT THE PATIENT UNDERWENT AN EMERGENT LEFT HEART CATHETERIZATION CORONARY ANGIOGRAPHY WITH A PERCUTANEOUS CORONARY INTERVENTION. DURING THE PLACEMENT OF THE STENT IN THE OM2 VESSEL THE TIP OF THE GUIDE WIRE BECAME STUCK UNDERNEATH THE STENT AND BROKE OFF. THE TIP OF THE GUIDEWIRE WAS REPORTED TO BE CAUGHT BETWEEN THE STENT AND THE CORONARY WALL. ADDITIONAL INFORMATION WAS RECEIVED ON 12/19/18: THE TIP OF THE GUIDEWIRE STILL REMAINS IN THE PATIENT. THE PATIENT IS IN STABLE CONDITION. A STENT PLACEMENT WAS USED WITH THE WIRE. BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8202522 ↗
• InjuryMar 16, 2018Fracture; Fracture

  THE USER FACILITY REPORTED THE DOCTOR WAS USING THE HYPERCOAT WIRE WHEN IT BECAME TANGLED IN A STENT, WHEN HE TRIED TO PULL THE WIRE BACK IT BECAME STUCK. ONCE HE WAS ABLE TO DISLODGE IT, THE TIP OF THE WIRE HAD COME APART. THE TIP WAS ASPIRATED OUT THROUGH A CATHETER AND NOTHING WAS LEFT IN THE PATIENT. PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018. THE PATIENT WAS STABLE AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE STENT THAT THE WIRE BECAME STUCK IN WAS AN ABBOTT STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7346225 ↗