R2P Destination Slender GS-R6ST1C10WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00389701012353), received between Feb 17, 2022 and Oct 23, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionOct 23, 2024Break; Difficult to Remove; Break; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE DESTINATION SLENDER SHEATH UNRAVELED IN THE RADIAL ARTERY DUE TO SPASM. PATIENT HAD TO GO FOR SURGERY AND THE DEVICE WAS REMOVED DURING SURGERY. THE PROCEDURE BEING PERFORMED WAS A SUPERIOR MESENTERIC ARTERY (SMA) STENTING. THE PATIENT WAS FINE PRE PROCEDURE, ALERT AND AWAKE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 25SEPT2024: RESISTANCE WAS ENCOUNTERED UPON REMOVAL DUE TO SPASM. WE INFLATED BLOOD PRESSURE (BP) CUFF HIGHER UP THE ARM, GAVE MORE NITRO, PATIENT WAS SEDATE AS WE HAD ANESTHESIOLOGIST FOR THE CASE. THE PATIENT WAS STABLE. AFTER CUT-DOWN AND RETRIEVING THE SHEATH THEY GAINED ACCESS HIGHER IN THE BRACHIAL AND THE SUPERIOR MESENTERIC ARTERY (SMA) STENTING WAS COMPLETED. THE PATIENT WAS A SKINNY OLDER LADY.

  Patient problems: Cramp(s) /Muscle Spasm(s); Foreign Body In Patient

  MAUDE report 20516008 ↗
• MalfunctionMay 3, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR PERFORMED AN R2P PROCEDURE. THE LEFT RADIAL WAS SMALL, AROUND 2.0 MM. THE DOCTOR WAS AN EXPERIENCE R2P OPERATOR AND KNEW THAT IT WAS SMALL, HOWEVER HE DEEMED IT SAFE. THEY WERE ABLE TO SUCCESSFULLY TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE RIGHT EXTERNAL ILIAC WITH SHOCKWAVE AND STENT. HE THEN TREATED LEFT COMMON ILIAC WITH STENT. HE REMOVED THE SHEATH WITH THE DILATOR AND .035 GUIDEWIRE ADVANTAGE (GWA). HE EXPERIENCED SPASM WHICH HE ANTICIPATED. THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE (MAC). HE FELT RESISTANCE HOWEVER DEEMED IT SAFE TO REMOVE THE SHEATH. THE SHEATH WAS SUCCESSFULLY REMOVED, HOWEVER, THERE WAS SOME SEPARATION IN THE SHEATH ONCE IT WAS REMOVED. THERE WAS NOTHING LEFT BEHIND AND NO COMPLICATIONS. THERE WAS NO ADVERSE EVENT AND NO BLOOD LOSS. TYPE OF PROCEDURE PERFORMED WAS A RIGHT AND LEFT ILIAC INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237861 ↗
• InjuryApr 1, 2023Material Split, Cut or Torn; Physical Resistance/Sticking; Material Split, Cut or Torn; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT WHEN ATTEMPTING TO REMOVE THE INVOLVED DESTINATION SLENDER SHEATH FROM THE RADIAL ARTERY, THE SHEATH HUB SPLIT APART FROM THE SHEATH SHAFT. THE PHYSICIAN SAID THAT HE DID NOT PULL ANY OF THE SHEATH SHAFT OUT OF WRIST PRIOR TO INFLATING THE TR BAND. THEREFORE, THE FULLY INFLATED TR BAND HAD TOO MUCH FRICTION WITH THE SHEATH WHILE REMOVING THE SHEATH WHICH SEVERED THE SHEATH HUB FROM THE SHEATH SHAFT. THE RESISTANCE WAS NOT CREATED FROM RADIAL ARTERY SPASM PER THE PHYSICIAN. TO REMOVE THE ENTIRE SHEATH, THE PHYSICIAN PERFORMED CUT DOWN SURGERY TO REMOVE THE SHEATH. THIS WAS PERFORMED SUCCESSFULLY. PATIENT CONDITION WAS STABLE. THE EVENT OCCURRED INTRA- OPERATIVE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. SURGICAL INTERVENTION WAS REQUIRED AS A CUT DOWN SURGERY WAS DONE ON THE RADIAL ARTERY TO REMOVE THE SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 08 MARCH 2023: THE PROCEDURE PERFORMED FOR THE PATIENT WAS LOWER EXTREMITY ANGIOGRAM. THE DOCTOR STATED THERE WAS NO RADIAL ARTERY SPASM, HE SAID THE RADIAL ARTERY WAS NOT DAMAGED AND THIS WAS CAUSED BY TENSION BETWEEN FULLY INFLATED TR BAND AND DESTINATION SLENDER SHEATH. HE DID NOT PULL THE SHEATH OUT AT ALL

  Patient problems: Obstruction/Occlusion

  MAUDE report 16660737 ↗
• MalfunctionAug 21, 2022Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE DESTINATION SLENDER GUIDING SHEATH SPRAYED CONTRAST ON TO PHYSICIAN AND TECHNOLOGIST UPON HAND INJECTING CONTRAST THROUGH THE SHEATH. THE SHEATH VALVE SPRAYS CONTRAST AND COULD ALSO BLOOD CAN SPRAY ALL OVER. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE TYPE OF PROCEDURE BEING PERFORMED WAS A RADIAL TO PERIPHERAL ANGIOPLASTY WITH STENT PLACEMENT. THE PROCEDURE WAS COMPLETED USING THE DEVICE. SPRAYS FROM THE VALVE UPON HAND INJECTING CONTRAST MAY HAVE COME OUT FROM LEAFLETS THAT SUPPORT THE WIRE IN CENTER OF SHEATH. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263499 ↗
• InjuryFeb 17, 2022Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT AFTER THE PROCEDURE WAS COMPLETE, THE DOCTOR WAS WITHDRAWING THE R2P GUIDING SHEATH WITH THE DILATOR IN IT. WHEN THE DOCTOR GOT TO THE DISTAL PART OF THE SHEATH THAT WAS IN THE BRACHIAL ARTERY, THE DOCTOR STOPPED AND WITHDREW THE DILATOR BECAUSE THE DOCTOR WANTED TO GIVE MORE NITRO. THE DOCTOR THEN PROCEEDED TO PULL ON THE SHEATH, WITHOUT THE DILATOR IN IT, AND MET RESISTANCE. THE DOCTOR THEN PULLED MUCH HARDER, AND THE SHEATH SEPARATED LEAVING A DISTAL PIECE OF THE SHEATH IN THE RADIAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED ON 28 JAN 2022: THE PROCEDURE PERFORMED WAS A LEFT COMMON ILIAC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) PTA, STENTING, AND A LEFT POPLITEAL PTA. THE PATIENT HAS GANGRENOUS ANKLE AND FOOT, AND THIS PROCEDURE WAS DONE TO ENSURE GOOD BLOOD FLOW PRIOR TO A BELOW KNEE AMPUTATION. THE DILATOR WAS REMOVED TO GIVE NITRO TO ALLEVIATE PERCEIVED SPASM. THE PATIENT WAS TAKEN INTO SURGERY WITHIN TWO HOURS AND HAD ULNAR PULSE AND PULSE OXYGEN (OX) READING ON THE RIGHT HAND (WHERE THE PROCEDURE WAS DONE). THE VASCULAR SURGEON FOUND THE SHEATH TO BE LODGED IN THE RADIAL ARTERY WITH SOME CALCIUM A

  Patient problems: Calcium Deposits/Calcification; Foreign Body In Patient

  MAUDE report 13548902 ↗