R2P Destination Slender GS-R6ST1C85WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701012377), received between Apr 5, 2021 and Mar 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionMar 8, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION SLENDER SHEATH WAS INSERTED INTO THE PATIENT'S ARM, WHEN THE PHYSICIAN NOTICED WHAT WAS DESCRIBED AS A BARB IN MID SHAFT. THE PHYSICIAN STOPPED INSERTING AND REMOVED THE SHEATH. THERE WERE NO ADVERSE EVENTS AS A RESULT. THE PROCEDURE WAS A SUCCESS, AND THE PATIENT CONDITION IS STABLE. PROCEDURE PERFORMED FOR THE PATIENT WAS A CELIAC ARTERY ANGIOGRAM. NO BLOOD LOSS WAS REPORTED. NO PATIENT INJURY AND/OR REQUIRED MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 12 FEB 2024: THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT USING THE SHEATH. CATHETER USE ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18871764 ↗
• InjuryNov 16, 2023Material Frayed; Material Frayed

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE SHEATH WAS REMOVED WITHOUT THE DILATOR BUT OVER THE WIRE. FELT THE SHEATH TUG A LITTLE SO THOUGHT THERE WAS A SPASM AND AS IT WAS PULLED IT STARTED TO SHRED. THEN THE DOCTOR CAME AND PULLED IT OUT AND IT FRAYED OFF AND WAS LEFT BEHIND. THE DOCTOR THOUGHT THAT THE FRAYED PIECE WAS ALL OUT OF THE RADIAL ARTERY. HOWEVER, THE PATIENT WAS IN THE HOSPITAL AND LEFT AND WITHIN 12 HOURS CAME BACK TO HOSPITAL WITH SWELLING IN THE ARM. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE VASCULAR SURGEON (VA) REMOVED A COUPLE MM OF METAL LEFT BEHIND FROM THE SHEATH. THROMBECTOMY OF THE RIGHT RADIAL AND BRACHIAL. PATIENT OUTCOME AND ARM IS NOW STABLE. THE PATIENT WAS STILL IN PATIENT CARE IN THE HOSPITAL BUT DUE TO A RESPIRATORY FAILURE UNRELATED TO THE INCIDENT. THE EVENT OCCURRED INTRA-OPERATIVE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THERE IS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: Foreign Body In Patient; Pain; Swelling/ Edema

  MAUDE report 18157008 ↗
• InjuryApr 5, 2021Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE DOCTOR LEFT THE DESTINATION SLENDER OVER NIGHT WHILE GIVING LYSIS TO FEM POP. THE SITE NEEDED TO BE REPAIRED (OPEN). HAD TO OPEN AT AXILLARY SITE. THE PATIENT WAS STABLE AT HOME. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 30MARCH2021: THE PROCEDURE WAS A RADIAL APPROACH TO STENT THE (SFA) SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN LEFT THE DESTINATION SLENDER IN OVERNIGHT AS THE PATIENT HAD A LYSIS CATHETER THROUGH THE SHEATH THAT NEEDED TO ADMINISTER MEDICINE. THERE WASN'T A DEFECT WITH THE DESTINATION SLENDER. THE PHYSICIAN COULD NOT GAIN RADIAL ACCESS SO HAD TO GO AXILLARY. HE COULD NOT REMOVE THE SHEATH SO HAD TO OPEN THE ACCESS THE SITE AND REPAIRED IT. THE PATIENT HAD A HEMATOMA AT THE ACCESS SITE. THERE WERE NO OTHER ISSUES. THE PATIENT WENT HOME AND IS DOING FINE.

  Patient problems: Hematoma

  MAUDE report 11615695 ↗