R2P Destination Slender GS-R6ST1C75WRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00389701012360), received between May 4, 2022 and Apr 10, 2026 — classified as 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Break; Unraveled Material; Physical Resistance/Sticking

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING A LEFT HEART CATH/CABS WITH PCI VIA LEFT RADIAL ARTERY ACCESS (LRA), THE 75CM R2P SHEATH UNRAVELED IN THE PATIENT AS IT WAS BEING REMOVED. THERE WAS NO MENTION ASSESSING LRA SIZE; HOWEVER, THE PHYSICIAN ACKNOWLEDGED THE RA TO BE OF SMALL CALIBER. THE PATIENT EXPERIENCED A SPASM PRIOR TO SHEATH INSERTION. TO TOLERATE THE PROCEDURE AND R2P SHEATH, THE PATIENT WAS GIVEN ''A LOT'' OF SEDATION. UPON REMOVAL OF THE SHEATH, THE PHYSICIAN FELT RESISTANCE WHEN PULLING. DESPITE THIS, THE DOCTOR CONTINUED TO PULL THE SHEATH SLOWLY, BY GRIPPING AT THE HUB/VALVE AREA. THE SHEATH BEGAN TO UNRAVEL IN THE PATIENT, AND THE SHEATH BROKE AT THE PROXIMAL END. THE DOCTOR STATED THAT DESPITE THE INCIDENT THEY WERE ABLE TO REMOVE ALL THE SHEATH COMPONENTS FROM THE VESSEL. NO ANESTHESIA CONSULTATIONS OR VASCULAR SURGERY CONSULTION WAS CONDUCTED. THE PATIENT WAS RECOVERED. A FOREARM HEMATOMA WAS NOTED AND MANAGED. AN ULTRASOUND (US) WAS PERFORMED AND NO ARTERIAL BLEEDING OR DAMAGE; HOWEVER, NO VENOUS THROMBUS WAS NOTED. THE BLOOD LOSS WAS LESS THAN 250CC.

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

  MAUDE report 24845072 ↗
• InjuryApr 6, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN TRYING TO REMOVE SHEATH, RESISTANCE WAS MET DUE TO RADIAL ARTERY SPASM SO THEY EVENTUALLY WENT FEMORAL. WHEN TUGGING HARDER THE SHEATH CAP CAME OFF AND EVENTUALLY THE PATIENT HAD TO HAVE SHEATH REMOVED VIA SURGERY. THE PATIENT REMAINED IN STABLE CONDITION. IT IS UNKNOWN IF IT WAS TIGHTLY SCREWED DOWN HOWEVER, WHEN TRYING TO PULL SHEATH OUT IT CAME OFF. THEY WERE NOT USING THE DILATOR, AND THE COIL BEGAN TO SEPARATE. THE PROCEDURE PERFORMED WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). THE ESTIMATED BLOOD LOSS COUNT WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796140 ↗
• MalfunctionDec 3, 2025Separation Problem; Separation Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: IT WAS NOTICED THAT THE DESTINATION SLENDER STARTED TO SEPARATE BELOW THE HUB AFTER PULLING DIRECTLY OUT OF THE PACKAGE. THE PROCEDURE WAS A CARDIAC CATHETERIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712124 ↗
• InjuryJul 25, 2025Break; Stretched; Break; Stretched

  THE USER FACILITY REPORTED THAT THE SHEATH WAS REMOVED WITHOUT THE DILATOR DURING RADIAL ARTERY SPASM. THE SHEATH STRETCHED AND FRACTURED. THE PATIENT HAD TO GO TO SURGERY TO REPAIR. THE TYPE OF PROCEDURE PERFORMED WAS A CORONARY PROCEDURE. THE ESTIMATED BLOOD LOSS WAS LESS THEN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 01JUL2025: IT IS UNKNOWN WHAT SIZE GLIDESHEATH SLENDER (GSS) WAS USED TO START, HOWEVER, THE DECISION WAS MADE TO UPSIZE TO THE DESTINATION SLENDER SHEATH (DSS). WHILE ATTEMPTING TO ADVANCE DIAGNOSTIC CATHETER, THERE WERE TIGHT SPOTS THAT WERE FELT IN THE UPPER ARM (BRACHIAL ARTERY). THIS IS WHEN THE DECISION WAS MADE TO INSERT THE DESTINATION SLENDER SHEATH (DSS). AFTER PROCEDURE WHILE REMOVING THE DESTINATION SLENDER SHEATH (DSS) WITH DILATOR IN PLACE, THE PATIENT BEGAN TO CRY OUT IN MID-FOREARM (RADIAL ARTERY). WHEN THE SHEATH CAME OUT, THE DISTAL END WAS DAMAGED WITH THE COIL WIRE PROTRUDING. THE PATIENT WENT TO SURGERY. THE DOCTOR STATED THAT THE VESSELS WERE SMALLER THAN USUAL. DESTINATION SLENDER SHEATH (DSS) IN-SERVICING HAS BEEN SCHEDULED TO MAKE SURE STAFF IS AWARE OF 2.3MM - 2.5MM MINIMUM DIAMETERS FOR RADIAL ARTERY. THE PATIENT WAS STABLE POST-SURGIC

  Patient problems: Pain

  MAUDE report 22605856 ↗
• InjuryJun 4, 2025Break; Unraveled Material; Obstruction of Flow; Failure to Advance; Break; Unraveled Material; Obstruction of Flow; Failure to Advance

  THE USER FACILITY REPORTED THAT (B)(6) 2025, A NURSE FROM THE CARDIAC CATH LAB CALLED TO SAY THAT THE DESTINATION SLENDER SHEATH HAD ''SNAPPED OFF'' AND ''UNRAVELED'' IN THE PATIENT'S ARM. HE STATED THAT THE PATIENT WAS STABLE AND WOULD BE TRANSFERRED TO SURGERY FOR REPAIR. THE TYPE OF PROCEDURE WAS A CARDIAC CATHETERIZATION. THE BLOOD LOSS WAS LESS THAN 250CC. THE INJURY WAS DESCRIBED AS SURGICAL REPAIR OF THE ARTERY. ADDITIONAL INFORMATION WAS RECEIVED ON 20MAY2025: STANDARD RADIAL ACCESS WAS GAINED WITH A 6 FRENCH 10CM GLIDESHEATH SLENDER. THE PHYSICIAN WAS UNABLE TO ADVANCE A CATHETER PAST THE FOREARM; THEREFORE, DECIDED TO INTRODUCE THE DESTINATION SLENDER. THE DESTINATION SLENDER STOPPED AT THE SAME POINT IN THE FOREARM AS THE CATHETER; THEREFORE, THE PHYSICIAN CONVERTED TO GROIN ACCESS. THE DESTINATION SLENDER WAS LEFT IN THE RADIAL ARTERY FOR THE DURATION OF THE PROCEDURE. UPON ATTEMPTED REMOVAL OF THE DESTINATION SLENDER, IT WOULD NOT MOVE. THE PHYSICIAN WAS UNABLE TO DELIVER RADIAL COCKTAIL. THERE WAS NO BLEED BACK OR ASPIRATION FROM THE SHEATH. THE MEDICAL DOCTOR (MD) STATED THAT THE DILATOR AND A WIRE WERE THEN INSERTED TO ASSIST WITH REMOVAL, WITHOUT SUCCESS. THE PHYSI

  Patient problems: Vascular Dissection

  MAUDE report 22143431 ↗
• InjuryMar 19, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT A PHYSICIAN WAS PERFORMING A RADIAL CARDIAC CATHETERIZATION USING A 75-CENTIMETER DESTINATION SLENDER SHEATH. THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ADVANCING THE SHEATH INTO THE RADIAL ARTERY, WHICH WAS SUSPECTED TO BE DUE TO A RADIAL ARTERY SPASM. THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH FROM THE RADIAL ARTERY BUT WAS INITIALLY UNABLE TO DO SO. AFTER MULTIPLE ATTEMPTS, THE SHEATH WAS EVENTUALLY REMOVED, BUT THE DISTAL TIP OF THE SHEATH HAD SEPARATED AND REMAINED INSIDE THE PATIENT. THIS NECESSITATED SURGERY TO REMOVE THE DISTAL TIP. A SUCCESSFUL CUT-DOWN SURGERY WAS PERFORMED TO REMOVE THE DISTAL PORTION OF THE SHEATH. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025: THE PATIENT WAS GIVEN FENTANYL AND MIDAZOLAM AT THE TIME OF THE ARTERY SPASM. THE PROCEDURE WAS COMPLETED AS INTENDED AFTER A SURGEON PERFORMED A CUT-DOWN OF THE RADIAL ARTERY. THE PATIENT'S CONDITION WAS STABLE AFTER THE INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21646904 ↗
• MalfunctionDec 9, 2024Material Separation; Material Deformation; Material Separation; Material Deformation

  THE USER FACILITY REPORTED THAT THE SHEATH BROKE INTO TWO PIECES NEAR THE HUB. THE PROCEDURE PERFORMED WAS A CARDIAC ANGIOPLASTY. THERE WAS NO INJURY OR BLOOD LOSS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 29NOV2024: THE DEVICE WAS NOT BEING USED ON THE PATIENT AT THE TIME THE BREAKAGE OCCURRED. THERE WERE NO PARTICLES OF THE SHEATH INSIDE THE PATIENT. THERE WAS NO PLAQUE OR STENOSIS PRESENT AT THE INSERTION SITE. THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED USING A SECOND DESTINATION SLENDER. THE PROCEDURE WAS SUCCESSFUL. THE CUSTOMER ADDED THE FOLLOWING COMMENTS: WHEN REMOVING THE INTRODUCER FROM ITS HOOP-SHEATH, THE METAL OF THE INTRODUCER WAS LOOSE AND DEFORMED. WE USED ANOTHER ONE AFTERWARD, AND EVERYTHING WAS PROPERLY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878029 ↗
• InjuryOct 3, 2024Break; Difficult to Remove; Physical Resistance/Sticking; Break; Difficult to Remove; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THEY HAD AN AORTIC STENOSIS PRESSURE GRADIENT PROCEDURE. THE OPERATOR ADVANCED THE INITIAL 6FR GLIDESHEATH SLENDER INTO THE RADIAL ARTERY THEN SWAPPED FOR A 75CM DESTINATION SLENDER. ADVANCED PIGTAIL PAST THE AORTIC VALVE TO TAKE SIMULTANEOUS PRESSURES. ONCE FINISHED, THEY WENT AHEAD AND TRIED TO REMOVE THE SHEATH WITHOUT DILATOR. RADIAL SPASM OCCURRED AND OPERATOR TRIED TO SEDATE PATIENT, ADMINISTERED NITRO AND ADDITIONAL COCKTAILS, PUT UNDER GENERAL ANESTHESIA HOWEVER, NO LUCK IN RELIEVING THE SPASM. AFTER TWO HOURS THE SHEATH SEEMED TO MOVE A BIT, AND THEY TRIED TO PULL IT OUT. SHEATH PULLED OUT BUT STAINLESS-STEEL COILS REMAINED INSIDE THE BODY. THE PATIENT WAS SENT TO SURGERY FOR CUT-DOWN REMOVAL. THEY DID NOT MEASURE THE RADIAL ARTERY GOING IN AND TURNED OUT TO BE A TORTUOUS HIGH RADIAL BRACHIAL TAKE-OFF WHERE THE SHEATH SEEMED TO HAVE KINKED AND GOT STUCK. THE SURGERY WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 16SEPT2024: THE PATIENT WAS DOING FINE, AND BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20360814 ↗
• InjuryJul 15, 2024Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT THE R2P SHEATH UNRAVELED AT THE END OF THE CASE WHEN THE PHYSICIAN ATTEMPTED TO REMOVE DEVICE FROM THE PATIENT. SMALL CALIBER VESSEL. THE PHYSICIAN REINSERTED THE DILATOR, TRIED TO PULL IT OUT, THEN IT STARTED TO UNRAVEL. THE COMMENT WAS, "DIDN'T PULL OVERLY HARD". TRIED TO REMOVE THE DILATOR, AND THEY WERE GOING TO PUT A LONG 2.0 BALLOON IN AND PULL OUT; HOWEVER, THE DILATOR TORE THE INNER LUMEN WHEN IT WAS REMOVED. THE PATIENT STARTED TO BLEED, AND THEY CLAMPED OFF THE BLEEDING. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) FOR SURGICAL REMOVAL. THE SHEATH WAS SUCCESSFULLY REMOVED IN THE OR AND PATIENT WAS RECOVERING. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT RESULTED IN PATIENT INJURY AND/OR REQUIRE 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. NO EQUIPMENT OR OTHER DEVICES WERE USED WITH THE INVOLVED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 19JUN2024: THE PROCEDURE PERFORMED WAS A LEFT HEART CATHETERIZATION FROM THE RIGHT RADIAL ARTERY. ANGIOGRAM AND INTRAVASCULAR ULTRASOUND (IVUS) WERE PERFORMED. UPO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19741924 ↗
• InjuryMar 30, 2024Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED THAT THE INVOLVED DESTINATION DEVICE WAS USED FOR AN INTERVENTION FOR AN OSTIAL RIGHT CORONARY ARTERY (RCA). THE DOCTOR GAIN RADIAL ACCESS THROUGH THE LEFT RADIAL ARTERY AND PLACED A 75 CM R2P DESTINATION. UPON COMPLETION OF THE INTERVENTION, THE PHYSICIAN ATTEMPTED TO REMOVE THE SHEATH BUT WAS STUCK. HE THEN GAVE VERSED, WAITED SOME TIME BEFORE ATTEMPTING TO REMOVE THE SHEATH, THEN DECIDED TO TAKE THE PATIENT TO THE OR FOR SURGICAL REMOVAL. THE EVENT OCCURRED INTRA-OPERATIVE. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2024: THE DEVICE BEGAN TO HAVE ISSUES DURING REMOVAL. THE DEVICE HAD TO BE SURGICALLY REMOVED. THE DEVICE FELL APART DURING THE REMOVAL PROCESS. THE PATIENT RECEIVED VERSED. THE PATIENT HAD AREAS OF PLAQUE. THEY WERE HAVING A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE PROXIMAL RCA. THE PATIENT EXPERIENCED LOSS OF RADIAL ARTERY. THE PATIENT IS STABLE AND HAS LIKELY BEEN DISCHARGED HOME. THERE WERE NORMAL ITEMS, GUIDE CATHETER, WIRE, AND BALLOON/STENTS USED WITH THE R2P DESTINATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19008983 ↗
• MalfunctionAug 25, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE USER FACILITY REPORTED THAT UPON PREP OF THE PRODUCT, THE PHYSICIAN NOTED THAT THE VALVE WOULD NOT TIGHTEN. IT SEEMED TO "ROLL BACK" OR LOOSEN AUTOMATICALLY. A SECOND SHEATH WAS OPENED AND USED. THIS SECOND SHEATH APPEARED TO TIGHTEN WHEN IN CONTACT WITH BLOOD BUT ULTIMATELY WAS NOT COMPLETELY SECURE. THERE WAS NO BLOOD LOSS. THERE IS NOT DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 31 JUL 2023: THE PROCEDURE PERFORMED PRIOR TO USING THE DEVICE WAS A CARDIAC CATHETERIZATION. THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED USING THE SECOND DEVICE. THE PROCEDURE WAS SUCCESSFUL. THERE WERE ADDITIONAL DEVICES USED WITH THE SECOND DEVICE. A SEQUENCE OF CATHETERS WAS USED TO ENGAGE THE CORONARY ARTERIES THAT WERE DELIVERED THROUGH THIS SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623220 ↗
• InjuryDec 15, 2022Break; Break

  THE USER FACILITY REPORTED THAT UPON COMPLETING PROCEDURE, THE DESTINATION SLENDER STARTED "THREADING" (UNRAVELING). THE SHEATH SEPARATED AND A PORTION OF THE DISTAL END REMAINED IN THE ARTERY. THE DOCTOR WAS ABLE TO REMOVE THE DISTAL SEGMENT SAFELY AND APPLIED A TR BAND. PER THE DOCTOR, THERE WAS NO INJURY TO THE PATIENT OR ARTERY. THE PATIENT WAS STABLE, AND THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 08 DEC 2022: THE PROCEDURE PERFORMED FOR THE PATIENT, AT THE TIME WAS A LOWER EXTREMITY INTERVENTION WITH LEFT RADIAL ACCESS. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WAS ONLY DIFFICULTY DURING WITHDRAWAL. DIFFICULTY REMOVING AND THEN THE DEVICE BROKE IN HALF. THE DILATOR WAS IN THE SHEATH DURING REMOVAL. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE DOCTOR STATED THAT IT WAS POSSIBLE PATIENT SPASM HAD OCCURRED. HE ALSO MENTIONED THAT HE MAY HAVE UNDERESTIMATED THE PATIENT'S ARTERY SIZE. IF A SPASM DID OCCUR THERE WAS NO MEDICAL INTERVENTION NECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15988147 ↗
• MalfunctionJul 20, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED R2P DESTINATION SLENDER DEVICE SHEATH HAD A BAD EDGE. THERE WAS NO PATIENT INJURY, AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JUN 2022: AT THE TIME THE BAD EDGE WAS DISCOVERED THE PROCEDURE PERFORMED ON THE PATIENT WAS A HEART CATHETERIZATION. IT WAS REPORTED THAT THEY "BELIEVE THE SHEATH CONDITION WAS DISCOVERED DURING THE PROCEDURE." THE PATIENT WAS IN STABLE CONDITION. THERE WAS NO OTHER EQUIPMENT OR DEVICES USED WITH THE INVOLVED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067388 ↗
• MalfunctionMay 13, 2022Material Separation; Stretched; Material Separation; Stretched

  THE USER FACILITY REPORTED THAT THE R2P SHEATH WAS PLACED IN THE ANTERIOR TIBIAL ARTERY. UPON REMOVAL OF THE SHEATH THERE WAS A SLIGHT RESISTANCE, WHICH MAY HAVE BEEN A SPASM. THE SHEATH CONTINUED TO BE REMOVED GENTLY DESPITE THE RESISTANCE. ONCE THE SHEATH EXITED THE BODY THERE WAS NOTICEABLE ELONGATION OF THE SHEATH, AND UPON EXAMINATION THE HOSPITAL STAFF NOTICED THE SHEATH STRETCHED AND HAD BEGUN TO SEPARATE, AND THEN THEY PULLED IT APART RESULTING IN A FULL SEPARATION OF THE SHEATH. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED TO PREVENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 21 APRIL 2022: THE PROCEDURE PERFORMED WAS A LOWER EXTREMITY ANGIOGRAM. THE EVENT OCCURRED UPON REMOVAL OF THE SHEATH, SO THE PROCEDURE WAS COMPLETED. THE SHEATH WAS ABLE TO BE FULLY REMOVED BECAUSE IT STAYED INTACT ENOUGH TO REMOVE. THOUGH, WHEN THE PROCEDURE WAS COMPLETED AND THE DEVICE REMOVED, THE HOSPITAL STAFF EXAMINED THE DEVICE AND WERE ABLE TO PULL IN APART WITHOUT MUCH EFFORT. THE DEVICE SEPARATED ON THE BACK TABLE AFTER REMOVAL FROM THE BODY. WHILE REMOVING TH

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

  MAUDE report 14398435 ↗
• InjuryMay 4, 2022Material Separation; Stretched; Material Separation; Stretched

  THE USER FACILITY REPORTED THAT A DESTINATION SLENDER AND A 4FR CATHETER WERE USED RADIAL TO RECORD THE PATIENT'S PRESSURE. THE PROCEDURE STARTED WITH A 6 FR TERUMO SHORT SHEATH, THEN A 0.035" WIRE WAS USED TO EXCHANGE A DESTINATION DEVICE. THE DESTINATION DEVICE WAS ADVANCED WITHOUT MUCH RESISTANCE, HOWEVER; WHEN THE END GOT TO THE SUBCLAVIAN, THE PATIENT HAD PAIN. THE DEVICE WAS NOT ADVANCED INTO THE ASCENDING AORTA DUE TO THE PATIENT'S PAIN. THE SHEATH WAS LEFT TO MONITOR PRESSURES AND WAS FLUSHED CONTINUOUSLY. SECONDARY ACCESS WAS ACHIEVED THROUGH THE FEMORAL ARTERY WITH THE DESTINATION DEVICE INVOLVED AND USED WITH A 4 FR CATHETER TO MEASURE PRESSURES IN THE HEART. WHEN COMPLETE, A 0.035" WIRE WAS ATTEMPTED TO BE PUT THROUGH THE DESTINATION SLENDER, IT WAS NOTICED ON FLUOROSCOPY THAT THE SHEATH LOOKED STRETCHED/BROKEN. THE DILATOR WAS ATTEMPTED TO BE PUT BACK IN, BUT IT WOULD NOT GO. ANOTHER CATHETER WAS TRIED, BUT IT WOULD NOT GO. WHEN THE SHEATH WAS PULLED BACK, THE PATIENT HAD PAIN WHEN THE TIP WAS BETWEEN THE SHOULDER AND ELBOW. THERE SEEMED TO BE A SPASM, BUT THE PATIENT COULDN'T BE PUT UNDER FURTHER SEDATION DUE TO A RISKY BODY MASS INDEX (BMI) (50). THE SHEATH BROKE AT

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

  MAUDE report 14279662 ↗