RUNTHROUGH 25-3013Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04987350721006), received between Mar 30, 2020 and Sep 2, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE TIP OF THE RUNTHROUGH DEVICE INVOLVED DAMAGED WHILE INSIDE THE BALLOON, DURING AN ANGIOPLASTY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A TECHNICAL SUCCESS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JUN 2022: A NEW WIRE WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON 19 AUG 2022: THE DOCTOR THOUGHT THE TIP WAS INSIDE OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15350008 ↗
• InjurySep 2, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE RUNTHROUGH DEVICE INVOLVED DAMAGED WHILE INSIDE THE BALLOON, DURING AN ANGIOPLASTY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS A TECHNICAL SUCCESS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JUN 2022: A NEW WIRE WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON 19 AUG 2022: THE DOCTOR THOUGHT THE TIP WAS INSIDE OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349705 ↗
• MalfunctionMar 30, 2020Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE INVOLVED FINECROSS WAS USED OFF LABEL IN THE AT TO CROSS. ONCE DOWN IN THE PEDAL ARCH, THE DOCTOR WANTED TO PULL THE HYPERCOAT OUT, TO EXCHANGE FOR VIPER WIRE SO THREY COULD SPIN. HOWEVER, THE HYPERCOAT WOULD NOT COME BACK. THE FINECROSS AND HYPERCOAT WERE TAKEN OUT OF PATIENT. ON THE BACK TABLE THE TECH PULLED ON THE HYPERCOAT AND THE FINECROSS BROKE/SHEARED IN THE MIDDLE. THE PATIENT'S CONDITION WAS STABLE. THEY HAVE TO BRING THE PATIENT BACK, AS THEY COULD NOT CROSS AGAIN. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 18OCT2020. THE HYPERCOAT WOULD NOT PULL OUT THE FINECROSS WHILE IN THE PATIENT, AT THAT POINT, THE DOCTOR PULLED THE WHOLE SYSTEM OUT, ONCE ON THE BACK TABLE, THE TECH PULLED ON THE HYPERCOAT AND FINECROSS BROKE APART. AFTER EVALUATION OF THE ACTUAL SAMPLE ON 10MAR2020, TERUMO REVISED THE REPORTABILITY OF THE REPORTED EVENT AS IT WAS CONFIRMED THAT THE GUIDE WIRE STUCK IN IT WAS RUN THROUGH NS HYPER COAT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9896967 ↗