DESTINATION RSC01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00389701006796), received between May 13, 2016 and Nov 1, 2022 — classified as 3 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE DESTINATION DEVICE INVOLVED WAS USED AND MEDICAL INTERVENTION REQUIRED. VIABAHN STENT WAS NEEDED TO FIX THE DISSECTION. THE PATIENT CONDITION WAS NOT AFFECTED. THE PATIENT PROCEDURE OUTCOME WAS NOT AFFECTED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PROCEDURE PERFORMED FOR THE PATIENT WAS A CAROTID ANGIO IMAGING STUDY. THE CAROTID WAS STENTED TO RESOLVE THE ISSUE AND CONTINUE THE PROCEDURE. ULTIMATELY THE PROCEDURE WAS SUCCESSFUL. THE PATIENT CONDITION WAS STABLE AND DISCHARGED AS NORMAL. THE DESTINATION DEVICE CAUSED THE DISSECTION THAT NEEDED TO BE STENTED. A SHORT 6 FRENCH 10 CM PINNACLE SHEATH WAS IN THE COMMON FEMORAL ARTERY AND USED THROUGH A HEADHUNTER CATHETER WITH A GWA .035 TO TAKE IMAGES. THE TORTURES RIGHT COMMON CAROTID WAS NOTED, SUPER STIFF AMPLATZ WAS PLACED THROUGH THE HEADHUNTER, HEADHUNTER WAS REMOVED A 6 FRENCH 90CM STRAIGHT DESTINATION SHEATH WAS PLACED IN THE COMMON CAROTID, IMAGING WAS DONE THROUGH THE SHEATH DISSECTION NOTED AT THE TIME. AN 8MM X 5CM GORE VIABAHN STENT WAS PLACED IN THE RIGHT CAROTID.

  Patient problems: Vascular Dissection

  MAUDE report 15712898 ↗
• MalfunctionJun 19, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN TOOK THE DESTINATION DEVICE FROM THE SHELF TO USE FOR THE PROCEDURE. WHILE STARTING TO OPEN THE PACKAGE HE SAW THAT GUIDING SHEATH DESTINATION WAS ALREADY KINKED IN THE ORIGINAL PACKAGE. ADDITIONAL INFORMATION WAS RECEIVED ON 03JUN2020. THE PROCEDURE TAKING PLACE FOR THE PATIENT AT THE TIME OF THE REPORTED EVENT WAS AN ENDOVASCULAR TREATMENT OF STROKE. THEY NOTICED THE ISSUE PRIOR TO PLACING IT. THEY USED A SECOND RSC01 TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172981 ↗
• InjuryApr 10, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT IT WAS NOTICED THAT THE INVOLVED 6FR DESTINATION SHEATH WAS KINKED AFTER OPENING THE BOX. THE BOX WAS NOT DAMAGED; HOWEVER, THE SHEATH WAS KINKED. THE PRODUCT WAS NOT USED. A COOK 6FR SHEATH WAS USED INSTEAD. THE PATIENT WAS IN GOOD CONDITION AND THE OUTCOME OF THE PROCEDURE WAS GOOD. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 24MAR2020. THE TYPE OF PROCEDURE BEING PERFORMED WAS AN ABDOMINAL AND LOWER EXTREMITY RUN OFFS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947596 ↗
• MalfunctionFeb 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE DESTINATION HUB DETACHED, THE HUB WAS DISLODGED FROM THE CATHETER. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 25FEB2020. THE PROCEDURE BEING PERFORMED WAS A CAROTID ARTERY STENTING (CAS). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW DESTINATION SHEATH. NO BLOOD LOSS WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9764167 ↗
• InjuryMay 13, 2016Break; Break

  THE USER FACILITY REPORTED THAT THE SHEATH UNRAVELED DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE PATIENT UNDERWENT A RIGHT LOWER EXTREMITY ANGIOGRAM WITH POPLITEAL AND TIBIAL ANGIOPLASTY FOR GANGRENE OF RIGHT FOOT; DURING THE CASE THE SHEATH WAS ADVANCED FROM THE LEFT COMMON FEMORAL ARTERY ACCESS UP AND OVER INTO THE RIGHT SFA IN ORDER TO CROSS THE OCCLUDED POPLITEAL ARTERY; WHEN THE ANGIOPLASTIES WERE COMPLETED, THE SURGEON ATTEMPTED TO REMOVE THE 6X90CM SHEATH OVER THE WIRE WHICH CONSISTED OF A 0.014 WIRE IN THE ANTERIOR TIBIAL ARTERY; INITIALLY THE SHEATH WAS ABLE TO BE PULLED BACK, HOWEVER, WITH ADDITIONAL PULLING OVER THE WIRE RESISTANCE WAS FELT AND THE SHEATH BEGAN TO UNRAVEL; FURTHER MOVEMENT WAS STOPPED AND THE VESSEL WAS CHECKED UNDER FLUOROSCOPY, IT WAS IDENTIFIED THAT THE SHEATH WAS UNRAVELING OVER THE AORTIC BIFURCATION; IN ADDITION TO FLUOROSCOPY, THE PRE-OPERATIVE CTA WAS EVALUATED AND NO SIGNIFICANT NARROWING IN THE ILIACS OR RIGHT SFA WERE FOUND TO EXPLAIN WHY THE SHEATH WAS CAUGHT; CONCERNED THAT FURTHER PULLING TO REMOVE THE SHEATH WOULD RESULT IN THE SHEATH COMING APART IN THE AORTA, ILIAC OR SFA OR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5654046 ↗