R2P Destination Slender GS-R6ST1C12WRecalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 00389701011547), received between Mar 14, 2018 and Aug 12, 2026 — classified as 36 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (49 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 25 most recent of 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222512 ↗
• InjuryJan 12, 2026Unraveled Material; Failure to Advance

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE DEVICE WAS PARTWAY IN THE PATIENT'S FOREARM, AND AN ATTEMPT WAS MADE TO PULL THE DEVICE OUT. HOWEVER, THE DEVICE STARTED TO UNRAVEL DUE TO SPASM. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE THE SHORT PART OF SHEATH LEFT IN THE FOREARM. THE PATIENT WAS STABLE WHEN THEY LEFT FOR SURGERY. THE BLOOD LOSS WAS LESS THAN 250CC. THE DEVICE UNRAVELED/BRAIDED COIL WHEN GOT STUCK SPASM WITHIN THE RADIAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED ON 27DEC2025: THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED WAS A LEFT RADIAL PERIPHERAL R2P CASE. THE MEDICATION THAT WAS GIVEN TO TREAT THE SPASM WAS NITRO. THE PATIENT HAS UNDERLYING HEALTH CONDITIONS OF PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT WAS STABLE FOLLOWING THE SURGERY. THE GENERAL SURGEON REMOVED SECOND SHEATH AND WIRE WHEN OTHER PHYSICIANS WERE OUT OF THE ROOM. WHEN THE FIRST SHEATH WAS REMOVED IT STARTED TO UNRAVEL. THERE WERE NO CONCOMITANT DEVICES USED WITH THE SHEATH.

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

  MAUDE report 24039459 ↗
• InjuryJan 12, 2026Unraveled Material; Failure to Advance

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. A RADIAL ARTERY SPASM OCCURRED, AND THE DEVICE COULD NOT BE ALL THE WAY IN. WHEN THEY ATTEMPTED TO PULL IT BACK OUT; HOWEVER, THE SHEATH UNRAVELED AND WAS PULLING APART. THE PATIENT WAS STABLE AND HEADED TO SURGERY TO REMOVE THE REMAINDER OF THE SHEATH/COIL FROM SHEATH. THE BLOOD LOSS WAS LESS THAN 250CC. THE DEVICE UNRAVELED/BRAIDED COIL WHEN GOT STUCK SPASM WITHIN THE RADIAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED ON 27DEC2025: THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED WAS A LEFT RADIAL PERIPHERAL R2P CASE. THE MEDICATION THAT WAS GIVEN TO TREAT THE SPASM WAS NITRO. THE PATIENT HAS UNDERLYING HEALTH CONDITIONS OF PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT WAS STABLE FOLLOWING THE SURGERY. THE GENERAL SURGEON REMOVED SECOND SHEATH AND WIRE WHEN OTHER PHYSICIANS WERE OUT OF THE ROOM. WHEN THE FIRST SHEATH WAS REMOVED IT STARTED TO UNRAVEL. THERE WERE NO CONCOMITANT DEVICES USED WITH THE SHEATH.

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

  MAUDE report 24038972 ↗
• InjurySep 13, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  TERUMO MEDICAL RECEIVED A MEDSUN VOLUNTARY REPORT (REPORT NUMBER (B)(4)) STATING THAT DURING REMOVAL OF A LEFT RADIAL ARTERY SHEATH, THE SHEATH BEGAN TO UNRAVEL AND BREAK. THE ISSUE OCCURRED AT THE CONCLUSION OF A PERIPHERAL VASCULAR ANGIOPLASTY PROCEDURE. THE DEVICE REPORTEDLY FAILED TO FUNCTION AS INTENDED AND EXPERIENCED A MALFUNCTION DURING REMOVAL. THE PROCEDURE WAS COMPLETED AS INTENDED; HOWEVER, THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE FRAGMENTS OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 14 AUG 2025: THE COMPLETE DATE OF THE EVENT WAS 28 JUL 2025. FRAGMENTS WERE SURGICALLY REMOVED AFTER THE SHEATH BEGAN TO UNRAVEL AND BREAK. THE PATIENT WAS NOT HARMED, AND BLOOD LOSS WAS NOT MORE THAN EXPECTED. THE PATIENT REMAINED STABLE. NO TORTUOSITY OR SPASM WAS PRESENT IN THE PATIENT'S ANATOMY AT THE TIME OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23047511 ↗
• MalfunctionAug 6, 2025Break; Difficult to Remove; Unraveled Material

  DURING THE REMOVAL OF THE LEFT RADIAL ARTERY SHEATH IT WAS NOTED THAT THE SHEATH BEGAN TO UNRAVEL AND BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725747 ↗
• InjuryJun 20, 2025Break; Unraveled Material; Physical Resistance/Sticking; Break; Unraveled Material; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PHYSICIAN CALLED THE TERUMO TERRITORY MANAGER DURING THE PROCEDURE, DUE TO DESTINATION SLENDER BEING STUCK INSIDE THE PATIENT'S ARM. THE PROCEDURE BEING PERFORMED WAS LOWER EXTREMITY ANGIO. THE PHYSICIAN NOTICED INITIAL RESISTANCE WHEN USING THE GLIDECATH PV MULTICURVE, AND AGAIN WHEN INITIALLY TRYING TO INSERT THE DESTINATION SLENDER. THE TECH ALSO OBSERVED THAT THE GLIDESHEATH SLENDER WAS CRIMPED DOWN WHEN REMOVING IT TO DO THE SHEATH EXCHANGE. NO ULTRASOUND MEASUREMENTS WERE DONE ON THE RADIAL ARTERY PRIOR TO INSERTING DESTINATION SLENDER. THE TERUMO TERRITORY MANAGER ARRIVED MID PROCEDURE. THE SHEATH HAD ALREADY STARTED TO UNWIND INSIDE THE ARM WHEN TRYING TO RETRACT IT. THE TERUMO TERRITORY MANAGER DISCUSSED TROUBLESHOOTING OPTIONS TO SAFELY REMOVE THE SHEATH, INCLUDING SEDATION, AND POTENTIALLY USING BLOOD PRESSURE CUFF TECHNIQUE. NONE OF THESE OPTIONS WOULD SAFELY GET THE SHEATH OUT, SO VASCULAR SURGERY NEEDED TO DO A BRACHIAL CUTDOWN TO REMOVE THE SHEATH. THE SHEATH WAS SUCCESSFULLY REMOVED AT SURGERY. THE TERUMO TERRITORY MANAGER, WHO WAS PRESENT MID CASE, STATED THAT THE ARTERY SHOULD HAVE BEEN MEASURED WITH ULTRASOUND PRIOR TO THE PROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294722 ↗
• InjuryApr 18, 2025Fracture; Unraveled Material; Fracture; Unraveled Material

  THE USER FACILITY REPORTED THAT AT THE END OF A PERIPHERAL INTERVENTION, THE SHEATH WAS ATTEMPTED TO BE REMOVED BUT WAS NOT ABLE TO BE PULLED BACK. A SEVERE SPASM WAS PRESENT AT THE FOREARM, WHICH HAD NOT BEEN PRESENT PRIOR. UPON ATTEMPTING TO PULL THE SHEATH OUT, THE BRAIDING BEGAN TO UNRAVEL. THE PATIENT HAD TO BE REFERRED TO VASCULAR SURGERY WHERE IT WAS SURGICALLY REMOVED. THE DEVICE IS CURRENTLY WITH THE QUALITY TEAM AT THE HOSPITAL SITE. THIS HAS BEEN ESCALATED TO THE HOSPITAL'S INTERNAL QUALITY TEAM. THE PROCEDURE PERFORMED WAS A PERIPHERAL INTERVENTION. NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 26 MAR 2025: THE SURGEON REPORTED THAT HE WAS ABLE TO SLOWLY REMOVE THE REMNANT AND SHEATH; HOWEVER, IT REPEATEDLY FRACTURED. HE FULLY MOBILIZED THE RADIAL ARTERY BY ABOUT 3 TO 4 CM. HE COULD NOT IDENTIFY ANY OBVIOUS REASON WHY THE SHEATH WOULD NOT BE REMOVED EASILY. ULTIMATELY, HE WAS ABLE TO SLOWLY RETRIEVE THE ENTIRETY OF THE SHEATH AS WELL AS THE RADIOPAQUE TIP WITH GENTLE RETRACTION. OF NOTE, THE PATIENT DID HAVE SIGNIFICANT CALCIFICATIONS INVOLVING THE RADIAL ARTERY. IT WAS A SMALL CALIBER ARTERY, AND HE HAD EVIDENCE OF CALCIPHYLAXIS. THE SURGEON SUSPECTS THIS CONTR

  Patient problems: Calcium Deposits/Calcification; Cramp(s) /Muscle Spasm(s)

  MAUDE report 21866959 ↗
• InjuryMar 26, 2025Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT UPON INSERTION OF THE 119CM DESTINATION SLENDER, IT WAS NOTICED THAT THE ENTRY WAS NOT SMOOTH AND FELT SOME RESISTANCE. NONETHELESS, THE DEVICE REACHED WHERE IT NEEDED TO BE. AFTER THE INTERVENTION WAS COMPLETE, THE DOCTOR INSERTED A .035 WIRE AND DILATOR BEFORE REMOVING THE LONG SHEATH. AT ABOUT THE HALFWAY POINT, THE SHEATH BROKE IN HALF AND GOT STUCK IN THE PATIENT. LUCKILY, THE BREAKAGE HAPPENED AT THE ARTERIOTOMY SITE, THEREFORE, THEY WERE ABLE TO PUT BACK THE WIRE AND DILATOR TO GET IT TO COME OUT. THE ADMINISTRATION OF VASODILATORS SEEMED TO HELP AS WELL. A VASCBAND WAS APPLIED AND THE PATIENT ROLLED OUT OF THE ROOM WITH NO ISSUE. THE DOCTOR BELIEVED IT COULD HAVE BEEN DUE TO SPASM AT THE ACCESS SITE; HOWEVER, THEY WANTED A THOROUGH INVESTIGATION INTO THE MATTER ANYWAYS. THE PROCEDURE PERFORMED WAS A RADIAL TO PERIPHERAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) INTERVENTION. THE BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO SURGICAL INTERVENTION REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21697083 ↗
• MalfunctionDec 12, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE INOLVED SHEATH BROKE DURING A PROCEDURE. THE DOCTOR WAS USING A DESTINATION SLENDER IN A PATIENT WITH A VERY SMALL RADIAL ARTERY AND APPLIED TOO MUCH FORCE. RESISTANCE WAS FELT WITH THE SHEATH, AND WHEN HE WITHDREW IT, IT BROKE. THE BREAK OCCURRED OUTSIDE THE BODY. THERE WAS NO INJURY TO THE PATIENT, AND THE ENTIRE SHEATH WAS REMOVED WITHOUT LEAVING ANY PIECES INSIDE. THE PROCEDURE PERFORMED WAS A CAROTID STENT. THE PATIENT'S CONDITION WAS STABLE. RELEVANT TESTS WERE NOT PROVIDED. THERE WAS NO BLOOD LOSS, AS IT WAS NOT APPLICABLE PRE-OPERATIVELY. THERE WAS NO INJURY DESCRIBED. THERE IS NO DIRECT ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919690 ↗
• InjuryDec 2, 2024Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD AN R2P PROCEDURE TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA) DISEASE. THE PHYSICIAN WENT RIGHT RADIAL AND WAS ABLE TO SUCCESSFULLY TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) DISEASE WITH A 119CM DESTINATION SLENDER SHEATH. PHYSICIAN WENT TO REMOVE THE SHEATH OVER A 035 GWA WHERE RESISTANCE WAS MET. PHYSICIAN CONTINUED TO PULL UNTIL THE SHEATH SEPARATED AND UNRAVELED AT THE RADIAL ACCESS SITE. A BALLOON WAS INSERTED AND INFLATED MULTIPLE TIMES INSIDE AND DISTAL OF THE SHEATH TO HELP WITH REMOVAL. THE SHEATH CONTINUED TO UNRAVEL. IR AND VASCULAR SURGEON WERE CALLED TO SURGICALLY REMOVE THE SHEATH. UNFORTUNATELY, THE PATIENT LOST THEIR RIGHT RADIAL ARTERY WHEN THE DISTAL END OF THE SHEATH WAS REMOVED. AFTER THE EVENT THE TERUMO FIELD CLINICAL SPECIALIST DISCUSSED PROPER DESTINATION SLENDER REMOVAL TECHNIQUES WITH THE PHYSICIAN BY REINSERTING THE DILATOR EVERY TIME ESPECIALLY WHEN RESISTANCE IS MET. THE PATIENT WAS RECOVERING IN THE INTENSIVE CARE UNIT (ICU). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Great Vessel Perforation

  MAUDE report 20818871 ↗
• InjuryNov 27, 2024Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON 06DEC2024: HALF OF THE SHEATH STAYED IN THE PATIENT'S BODY DURING THE INITIAL PROCEDURE WHERE THE SHEATH BROKE APART. EVENTUALLY ALL PIECES OF THE SHEATH WERE SUCCESSFULLY REMOVED BUT THAT WAS DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20801356 ↗
• MalfunctionNov 21, 2024Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  THE USER FACILITY REPORTED THAT DURING AN ENDO VASCULAR TREATMENT (EVT) PROCEDURE USING THE R2P DESTINATION SL GUIDING SHEATH VIA RADIAL APPROACH, BLOOD LEAKAGE WAS OBSERVED 2-3 CM FROM THE HUB AFTER PLACEMENT. UPON INSPECTION, A KINK IN THE SHEATH WAS IDENTIFIED AT THE LEAKAGE SITE. APPROXIMATELY 20 CC OF BLOOD WAS LOST, WHICH WAS CONSIDERED MINOR. CONSEQUENTLY, THE USE OF THE GUIDING SHEATH WAS DISCONTINUED, AND THE PROCEDURE WAS SWITCHED TO A FEMORAL APPROACH DUE TO THE CASE'S SEVERITY, NOT THE SHEATH ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT INJURY OR NEED FOR MEDICAL OR SURGICAL INTERVENTION. THE PHYSICIAN HAS REQUESTED VERIFICATION OF THE LEAKAGE CAUSE. THE EVENT WAS NOT DUE TO A PROBLEM WITH THE GUIDING SHEATH, BUT THE PHYSICIAN SEEKS TO UNDERSTAND THE CAUSE OF THE LEAKAGE. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE ABOVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754997 ↗
• InjuryNov 1, 2024Break; Difficult to Remove; Break; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE 119CM DESTINATION SLENDER SHEATH BROKE, LEAVING BEHIND APPROXIMATELY EIGHT TO TEN INCHES OF SHEATH IN THE BRACHIAL/RADIAL ARTERY. THE WIRE AND DILATER WERE INTRODUCED INTO THE SHEATH BEFORE REMOVAL. ADDITIONAL SEDATION WAS PROVIDED TO PATIENT PRIOR TO REMOVAL. THE SHEATH WAS PULLED BACK TO AUXILIARY ARTERY. XRAY MACHINE ADJUSTED, AND THE TR BAND WAS APPLIED (NOT INFLATED). SHEATH PULLED FURTHER TO BRACHIAL/RADIAL AREA WHEN IT WAS NOTICED SHEATH WAS ELONGATING/UNRAVELING OUTSIDE THE BODY. THE PHYSICIAN CHOSE TO PULL FURTHER WHEN IT COMPLETELY BROKE. THE SHEATH AND DILATOR WERE REMOVED, LEAVING BEHIND THE 035 WIRE. THE PHYSICIAN, PULLED ON COILED PORTION HANGING OUTSIDE BODY WHICH RESULTED IN FURTHER UNRAVELING OF SHEATH (PIECES INCLUDED). OVER THE WIRE A 4.0MM BALLOON WAS INTRODUCED AND INFLATED TO TRAVERS THE SHEATH CLOSER TO ARTERIOTOMY WHERE THE PHYSICIAN WAS ABLE GRAB HOLD AND REMOVE. A NEW TR BAND APPLIED AND INFLATED TO ACHIEVE HEMOSTASIS. DOPPLER AND ULTRASOUND (US) USED TO ASSESS VESSEL FOR ANY PERFORATION AND BLEEDING WITH NO ABNORMAL RESULTS. PATIENT HAD NO SIGNS OF HEMATOMA IN FOREARM. THERE WAS SWELLING AND BRUISING FOCAL TO TR BAND/AR

  Patient problems: Bruise/Contusion; Foreign Body In Patient; Swelling/ Edema

  MAUDE report 20588058 ↗
• InjurySep 6, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE R2P DESTINATION SHEATH BROKE INTO TWO PIECES WHEN TRYING TO REMOVE IT. THE DISTAL PORTION OF THE SHEATH HAD TO BE SURGICALLY REMOVED FROM THE BRACHIAL ARTERY. THE PROCEDURE FOR THE PATIENT WAS PERIPHERAL RADIAL TO PERIPHERAL (R2P). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 12AUG2024: THE PATIENT WAS ON THE FOLLOWING MEDICATIONS AT THE TIME OF THE PROCEDURE: XARELTO, PLAVIX, METFORMIN, LISINOPRIL, FLEXORIL. THE PATIENT CONDITION WAS FINE PRE-PROCEDURE. THERE WAS NO SPASM LEADING UP TO THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20160920 ↗
• MalfunctionJun 13, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THE R2P DESTINATION SL GUIDING SHEATH WAS USED TO TREAT BOTH ILIAC ARTERIES, ACCESSED VIA THE RADIAL ARTERY. TOWARDS THE END OF THE PROCEDURE, AFTER USING A NON-SLIP ELEMENT BALLOON CATHETER (APERTA NSE, NIPRO), A BLOOD LEAK WAS OBSERVED FROM THE PROXIMAL HUB SIDE OF THE GUIDING SHEATH. ON INSPECTION, THE GUIDING SHEATH WAS FOUND TO BE BROKEN. SINCE THE PROCEDURE WAS AT THE FINAL STAGE, THE GUIDING SHEATH WAS CONTINUED TO BE USED. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE GUIDING SHEATH. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. WHEN REMOVING THE BALLOON CATHETER FROM THE GUIDING SHEATH, HEAVY RESISTANCE WAS FELT DUE TO INSUFFICIENT DEFLATION OF THE BALLOON. THE REPORTED INCIDENT DID NOT RESULT IN A PATIENT INJURY OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION. THERE IS NO DIRECT CLAIM THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528115 ↗
• MalfunctionDec 29, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE WHEN THE R2P DESTINATION SL GUIDING SHEATH WAS PLACED AT THE INTENDED SITE, THE PROXIMAL PORTION OF THE SHEATH KINKED. IT WAS POSSIBLE THAT A FINGERNAIL HAD DUG INTO THE SHEATH OR TORQUE HAD BEEN APPLIED DURING PULL-PUSH MANIPULATION. AS THE KINK OCCURRED IN THE EXTRACORPOREAL PORTION OF THE GUIDING SHEATH AND DID NOT AFFECT ITS USE, THE PROCEDURE WAS CONTINUED USING THE GUIDING SHEATH. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422636 ↗
• MalfunctionNov 19, 2023Break; Break

  THE USER FACILITY REPORTED THAT THEY WERE PULLING THE R2P SHEATH OUT OF THE PATIENT AFTER THE PROCEDURE, AND IT CAME APART. THERE WAS NO PATIENT INJURY AND/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION AS RECEIVED ON 10NOV2023: THE CASE WAS AN R2P CASE. THE PATIENT DID NOT EXPERIENCE A SPASM WHEN THE DEVICE REMOVAL WAS TAKING PLACE. NO INJURY OR MEDICAL INTERVENTION TOOK PLACE DUE TO THE DEVICE COMING APART. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167397 ↗
• InjuryNov 11, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 17NOV2023: THE INTERVENTIONAL CARDIOLOGIST STATED THAT THE CUT DOWN AND PARTIAL REMOVAL OF THE RADIAL ARTERY WAS SUCCESSFUL. THE PATIENT DID NOT HAVE ANY ADDITIONAL COMPLICATIONS DURING OR AFTER THE SURGERY.

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

  MAUDE report 18117248 ↗
• MalfunctionJul 29, 2023Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 25 JUL 2023: THE PROCEDURE WAS COMPLETED ON ANOTHER DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17421592 ↗
• InjuryJul 1, 2023Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS PERFORMING A R2P PROCEDURE USING A 119CM DESTINATION SLENDER. THE PHYSICIAN WAS UNABLE TO REMOVE THE DESTINATION SLENDER SHEATH/DILATOR FROM PATIENT'S RADIAL ARTERY AT THE END OF A 2.5 HOUR PROCEDURE. A CUT DOWN WAS REQUIRED TO REMOVE THE SHEATH FROM THE PATIENT. THE CASE WAS COMPLETED, AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION POST PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT WAS DOING GREAT THE FOLLOWING MORNING. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE SHEATH FROM RADIAL ARTERY. THERE WAS NO REPORTED BLOOD LOSS. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17244359 ↗
• MalfunctionJun 19, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED R2P DESTINATION SLENDER WAS INSERTED THROUGH THE RADIAL ARTERY TO PERFORM A PERIPHERAL INTERVENTION. ONCE INTERVENTION WAS COMPLETED THE R2P DESTINATION WAS BEING REMOVED AND THE RADIAL ARTERY SPASMED. AS THE DOCTOR TRIED TO REMOVE THE R2P DESTINATION SLENDER ELONGATED AND SEVERED AND THE DISTAL PART OF THE SHEATH REMAINED IN PATIENT. VASCULAR SURGERY WAS CALLED AND NEEDED TO PERFORM A CUTDOWN SURGERY TO REMOVE SHEATH. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 05 JUN 2023: THE PATIENT WAS GIVEN MEDICATION TO TREAT THE SPASM WHEN IS OCCURRED. CONCOMITANT MEDICAL PRODUCTS USED WITH THE R2P WAS BALLOONS.

  Patient problems: Cramp(s) /Muscle Spasm(s); Device Embedded In Tissue or Plaque

  MAUDE report 17149609 ↗
• MalfunctionApr 29, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THEY HAS A (ST ELEVATION MYOCARDIAL INFARCTION) STEMI PERCUTANEOUS CORONARY INTERVENTION (PCI) CASE WITH ACCESS VIA THE RIGHT RADIAL WITH A 6FR X 10CM GLIDESHEATH SLENDER. TREAT CULPRIT LESION IN RIGHT CORONARY ARTERY (RCA). THEY ATTEMPTED TO ENGAGE LEFT CORONARY ARTERY (LCA) TO IMAGE AND TREAT, IF NECESSARY. HOWEVER, ANATOMY WAS CHALLENGING AND COULD NOT ENGAGE. THEY PREPPED A DESTINATION SLENDER AND ADVANCED OVER GUIDEWIRE, IT ADVANCED SMOOTHLY UNTIL TIP OF SHEATH REACHED SHOULDER REGION. IT COULD NOT BE ADVANCED FURTHER OR WITHDRAWN. AFTER A WHILE THEY GAINED FEMORAL ACCESS IN ATTEMPT TO GET SHEATH UNSTUCK THE USER FACILITY REPORTED THE INVOLVED R2P TREATMENT, A 0.035-INCH GUIDEWIRE WAS PRE-INSERTED INTO THE DILATOR OF THE GUIDING SHEATH AND THE DILATOR WAS INSERTED INTO THE ARTERY TO BE MATED WITH THE CATHETER FOR RETRIEVAL. THE GUIDING SHEATH WAS ATTEMPTED TO BE RETRIEVED; HOWEVER, RESISTANCE WAS FELT. THE GUIDING SHEATH WAS WITHDRAWN SLOWLY, NOT AT ONCE BUT SEVERAL TIMES, BUT RESISTANCE BECAME HIGHER. WHEN THE GUIDING SHEATH WAS CHECKED, IT WAS FOUND TO BE STRETCHED; THE TIP OF THE CATHETER WAS LOCATED ABOVE THE ELBOW AND THE TIP OF THE DILATOR

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 16841280 ↗
• InjuryApr 29, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE USER FACILITY REPORTED THAT AFTER THE PROCEDURE, THE RADIAL ARTERY WAS FOUND TO BE OCCLUDED. THE DETAILS ARE UNKNOWN. THE PATIENT CONDITION WAS NON-SERIOUS HEALTH DAMAGE (DETAILS UNKNOWN). THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16841125 ↗
• MalfunctionMar 22, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE R2P DESTINATION SLENDER GUIDING SHEATH WAS INSERTED VIA THE LEFT RADIAL ARTERY. HOWEVER, DUE TO THE TORTUOUS VASCULAR ANATOMY OF THE SUBCLAVIAN ARTERY, THE GUIDING SHEATH KINKED, MAKING FURTHER INSERTION DIFFICULT. THE GUIDING SHEATH WAS NOT USED AND THE APPROACH WAS CHANGED TO A FEMORAL ARTERY APPROACH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE TO TREAT THE ILLIAC WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE FOR THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590621 ↗
• MalfunctionMar 14, 2023Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE DESTINATION R2P DEVICE INVOLVED CAME OFF WHILE ATTEMPTING TO INSERT IT INTO THE ARTERY. THE PROCEDURE WAS A PACEMAKER INSERTION CASE. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539270 ↗