DESTINATION RSC08Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701007878), received between Aug 17, 2020 and Oct 5, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Material Deformation; Material Deformation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # 2000330000-2020-8043. THE EVENT DESCRIPTION STATES: "WE OPENED A 7FR 90CM ANGLED DESTINATION INTRODUCER. UPON TRYING TO INSERT IT, THE SURGEON NOTICED THAT IT WAS BENT AND FLATTENED, SO IT WAS UNUSABLE. A NEW INTRODUCER WAS OPEN, AND THE OTHER WAS REMOVED FROM THE FIELD. ORIGINAL INTENDED PROCEDURE: LEFT BRACHIAL CUTDOWN FOR ACCESS. DILATATION AND STENTING SUPERIOR MESENTERIC ARTERY." ADDITIONAL INFORMATION WAS RECEIVED ON 17SEP2020. THE ISSUE WAS FOUND WHILE ATTEMPTING TO BE INSERTED INTO THE PATIENT. THE PATIENT'S CONDITION WAS GOOD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10626204 ↗
• MalfunctionAug 17, 2020Material Deformation; Material Twisted/Bent

  FROM STAFF: WE OPENED A 7FR 90CM ANGLED DESTINATION INTRODUCER. UPON TRYING TO INSERT IT, THE SURGEON NOTICED THAT IT WAS BENT AND FLATTENED, SO IT WAS UNUSABLE. A NEW INTRODUCER WAS OPEN, AND THE OTHER WAS REMOVED FROM THE FIELD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10413150 ↗