R2P Destination SlenderRecalls & reported problems across all models
Terumo Medical Corporation · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 198
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls
- 0
We found 6 models of R2P Destination Slender by Terumo Medical Corporation in the FDA's device registry (GUDID). Together they are named in 198 adverse event reports in the FDA's MAUDE database, received between Mar 14, 2018 and Aug 12, 2026 — classified as 60 injuries, 138 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (60 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported R2P Destination Slender problems
Device problems
- Material Deformation60
- Physical Resistance/Sticking44
- Break34
- Material Separation20
- Unraveled Material20
- Leak/Splash19
- Difficult to Remove17
- Difficult to Advance15
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- Blood Loss47
- No Consequences Or Impact To Patient26
- Foreign Body In Patient24
- Cramp(s) /Muscle Spasm(s)19
- Pain8
- No Code Available5
- Calcium Deposits/Calcification4
R2P Destination Slender models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- R2P Destination Slender GS-R6ST1C12WINTRODUCER, CATHETER145 reports
- R2P Destination Slender GS-R6ST1C15WINTRODUCER, CATHETER20 reports
- R2P Destination Slender GS-R6ST1C75WINTRODUCER, CATHETER15 reports
- R2P Destination Slender GS-R6ST1C95WINTRODUCER, CATHETER10 reports
- R2P Destination Slender GS-R6ST1C10WINTRODUCER, CATHETER5 reports
- R2P Destination Slender GS-R6ST1C85WINTRODUCER, CATHETER3 reports
Recent R2P Destination Slender adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗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 ↗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 27, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND STENTING PROCEDURE OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), A 149 CM DESTINATION SLENDER SHEATH WAS INSERTED THROUGH THE RIGHT RADIAL ARTERY AND ADVANCED INTO THE PROXIMAL RIGHT SFA. AFTER WIRING, BALLOONING, AND STENTING OF THE RIGHT SFA, THE PHYSICIAN PREPARED TO REMOVE THE SHEATH AND INSERTED A 0.035-INCH GUIDEWIRE INTO IT. THE PHYSICIAN WAS ADVISED TO INSERT THE DILATOR INTO THE SHEATH PRIOR TO REMOVAL TO HELP PREVENT ELONGATION IF RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN ACKNOWLEDGED THAT THIS STEP IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU), BUT STATED THAT, BASED ON PRIOR EXPERIENCE, INSERTING THE DILATOR TENDS TO CAUSE MORE COMPLICATIONS THAN REMOVING THE SHEATH OVER THE GUIDEWIRE ALONE. WHILE PULLING BACK THE SHEATH, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN CONTINUED PULLING, WHICH CAUSED THE SHEATH TO ELONGATE. THE PHYSICIAN THEN INSERTED THE DILATOR AND RESUMED PULLING, BUT THE SHEATH CONTINUED TO ELONGATE. VASCULAR SURGERY WAS CONSULTED. THE SHEATH WAS CUT JUST PROXIMAL TO THE INSERTION SITE TO ALLOW FOR STERILE DRESSING APPLICATION. THE PATIENT WAS TRANSFERRED TO ANOTH
Patient problems: Foreign Body In Patient
MAUDE report 22350488 ↗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 ↗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 ↗InjuryMay 30, 2025Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking
ON 30MAY2025, TERUMO MEDICAL RECEIVED FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATED: AT COMPLETION OF A PERIPHERAL ANGIOGRAPHY AND INTERVENTION VIA THE LEFT RADIAL SHEATH, THE SHEATH WAS BEING REMOVED PER MIFU [MANUFACTURER'S INSTRUCTIONS FOR USE] AND THE SHEATH STARTED TO SEPARATION. SHEATH WAS NOT ABLE TO BE SUCCESSFULLY REMOVED. THE PATIENT WAS URGENTLY TRANSFERRED TO [REDACTED] FOR SURGICAL REMOVAL. MANUFACTURER RESPONSE FOR SHEATH, TERUMO R2P SHEATH 149 CM (PER SITE REPORTER). CATH LAB STAFF CONTACTED THE SALES REP, [REDACTED] TO INFORM HIM OF THE PATIENT TRANSFER AND HE COULD PICK UP SHEATH AFTER SURGICAL REMOVAL AT [REDACTED]. YESTERDAY, [REDACTED], RISK MANAGER CALLED TO CONFIRM THE SHEATH IS NOW IN STERILE PROCESSING FOR [REDACTED] TO PICK UP. I EMAILED [REDACTED] AND PER PHONE DISCUSSION, HE WILL PICK UP SHEATH TODAY FOR MANUFACTURER INVESTIGATION. BALLOON ANGIOPLASTY. WHAT PROBLEM DID THE USER HAVE:DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NO OTHER THERAPIES; PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE
Patient problems: Cramp(s) /Muscle Spasm(s)
MAUDE report 22115240 ↗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 ↗
Other Terumo Medical Corporation products
All Terumo Medical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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