R2P Destination Slender GS-R6ST1C15WRecalls & reported problems
Terumo Medical Corporation · R2P Destination Slender Guiding Sheath · Class 2
All models of R2P Destination Slender (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00389701011561), received between Sep 10, 2018 and Jun 27, 2025 — classified as 7 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (5 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation5
- Physical Resistance/Sticking5
- Break3
- Difficult to Advance3
- Difficult to Remove3
- Difficult to Insert2
- Material Separation2
- Stretched2
Patient problems
- Blood Loss7
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient4
- Foreign Body In Patient3
- Cramp(s) /Muscle Spasm(s)2
- Pain1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionDec 31, 2023Difficult to Insert; Difficult to Insert
THE USER FACILITY REPORTED THAT THE R2P DESTINATION SL GUIDING SHEATH WAS UNABLE TO PASS THROUGH THE ARTERY DUE TO VASCULAR SPASM. THE ACCESS WAS SWITCHED TO FEMORAL ARTERY ACCESS AND THE PROCEDURE WAS CONTINUED. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE BLOOD LOSS WAS LESS THAN 250CC. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. 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 18423024 ↗MalfunctionJun 18, 2022Fracture; Fracture
THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER FRACTURED UPON ADVANCEMENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PROCEDURE FOR THE PATIENT WAS R2P. TO RESOLVE THE ISSUE THE PHYSICIAN GAVE NITRO AND PULLED BACK. THE PHYSICIAN WAS ABLE TO REMOVE ALL THE SHEATH, INCLUDING ANY FRACTURED PIECES APART FROM THE SHEATH. THE PATIENT CONDITION WAS STABLE. THERE WAS NO EQUIPMENT OR OTHER DEVICES USED WITH THE REPORTED PRODUCT. THE ORIGINAL INTENDED PROCEDURE WAS ABLE TO BE COMPLETED. ANOTHER LONG DESTINATION SLENDER WAS USED, PERFORMED AND INTERVENTION. USER FACILITY REPORTED THAT THE DILATOR MAY HAVE NOT BEEN IN THE SHEATH WHEN EXTRACTING AND MOVING. THE ENTIRE SHEATH WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14739688 ↗InjuryMay 23, 2022Break; Break
THE USER FACILITY REPORTED THAT THE INVOLVED GUIDESHEATH SLENDER DEVICE SHEATH BROKE OFF IN THE PATIENT. PART OF THE SHEATH WAS LEFT BETWEEN THE SHOULDER AND THE WRIST. THE SHEATH WENT IN EASY, BUT PATIENT WAS A LITTLE SPASMATIC AND A SMOKER. THE DOCTOR REFERRED TO THE VESSEL AS APPROXIMATELY 3MM BUT VERY CALCIFIED. A VIPER WIRE WAS IN AT THE TIME OF EXTRACTION. THE PATIENT WAS GIVEN ADDITIONAL DRUGS BEFORE PULLING. 200 NITRO AND 100 FENTANYL. THE DOCTOR PUT IN A COUPLE SUTURES THAT STOPPED THE BLEEDING AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR VASCULAR CARE/VASCULAR SURGEON. PATIENT WAS DOING FINE. ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE AND GOOD CONDITION. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 26 APRIL 2022: IT WAS CONFIRMED THAT THE DILATOR WAS IN THE SHEATH WHEN THEY WENT TO WITHDRAWAL. ALL OF THE SHEATH WAS SUCCESSFULLY REMOVED BY THE VASCULAR SURGEON. TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4) ON 29 APRIL 2022. THE EVENT DESCRIPTION STATES: AN ELDERLY PATIENT UNDERWENT PERIPHERAL VASCULAR ANGIOGRAPHY FOR CLAUDICATION, ABNORMAL NON-INVASIVE STUDIES, FOOT WOUND AND PERIPHERAL
Patient problems: Cramp(s) /Muscle Spasm(s); Foreign Body In Patient
MAUDE report 14471932 ↗InjuryJan 27, 2022Break; Material Separation; Stretched; Break; Material Separation; Stretched
THE USER FACILITY REPORTED THAT THE PATIENT'S RADIAL ARTERY WAS ACCESSED VIA PALPATION, USING A R2P DESTINATION SLENDER, WITHOUT ULTRASOUND VERIFICATION OF ARTERY DIAMETER. THE RADIAL ARTERY SPASMED DOWN ON THE SHEATH WHEN IT WAS DEEPLY ENGAGED, WITH ABOUT 30CM EXTERNAL LENGTH. DURING REMOVAL, THE SHEATH ELONGATED AND ULTIMATELY BROKE. ABOUT A 20CM PIECE OF SHEATH REMAINED IN THE RADIAL ARTERY, WITH THE SHEATH TIP IN THE BRACHIAL. THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE SHEATH. INITIAL DOSE OF 5 VERAPAMIL WAS GIVEN. THE FINAL VERAPAMIL DOSE WAS 15. A 120 DOSE OF PROPOFOL WAS GIVEN BUT NEITHER MEDICATION ALLEVIATED THE SPASM. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS UNSUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 04JANUARY2022: THE PROCEDURE PERFORMED WAS ABDOMINAL AORTOGRAM WITH RUNOFF. THE INTENT WAS TO CROSS AN OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS AT REST WHEN THE SPASMS OCCURRED. THE PATIENT WAS DOING WELL AFTER THE REMOVAL OF THE SHEATH PIECE.
Patient problems: Foreign Body In Patient
MAUDE report 13369155 ↗InjuryApr 28, 2021Difficult to Remove; Material Separation; Material Deformation; Physical Resistance/Sticking; Difficult to Remove; Material Separation; Material Deformation; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED ON 07JUNE2021: THE EVENT THAT OCCURRED WAS CONFIRMED FOR THE PITCH OF THE COIL AT THE TIP OF THE GUIDING SHEATH WAS FOUND TO HAVE STRETCHED. TUCKING WAS PERFORMED AFTER THE COILING PROCESS THEREFORE THE END PART OF THE COIL WAS TUCKED BENEATH TO PREVENT UNRAVELLING. THERE WAS ALSO GAPS PRESENT BETWEEN THE COILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11737078 ↗MalfunctionFeb 12, 2021Break; Break
THE USER FACILITY REPORTED THAT THE PHYSICIAN PERFORMED AN INTERVENTION FROM THE RADIAL TO PERIPHERAL (R2P) APPROACH. THE CASE WAS SUCCESSFUL. UPON REMOVING THE R2P DESTINATION SHEATH OUT OF THE BODY THEY NOTICED THAT THE SHEATH HAD STARTED TO UNRAVEL. THERE WERE NO PARTS OF THE DEVICE LEFT BEHIND. THE DOCTOR FIXED THE LESION AND PATIENT WAS DOING WELL. THE PATIENT WAS IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 20JAN2021. THE EVENT OCCURRED INTRA-OPERATIVE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATION'S AND THE PATIENT WAS DISCHARGED HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11324392 ↗MalfunctionJan 13, 2021Material Deformation; Material Deformation
THE USER FACILITY REPORTED A KINK IN THE DESTINATION SHEATH. THE SHEATH WAS USED FOR TREATMENT OF SEVERE CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WERE SEVERE CALCIFICATION AND TORTUOSITY OF THE VESSEL, A KINK OF THE PROXIMAL PART OF THE SHEATH WAS CONFIRMED. THE SHEATH WAS NOT USED AND WAS REPLACED WITH ANOTHER SHEATH TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE FOR THE PATIENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11162784 ↗MalfunctionSep 3, 2020Material Deformation; Material Deformation
THE USER FACILITY REPORTED WHEN THE DILATOR WAS INSERTED INTO THE R2P DESTINATION SL GUIDING SHEATH AFTER OPENING THE PACKAGE, THE GUIDING SHEATH WAS KINKED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO BLOOD LOSS. THE WAS NO HEALTH DAMAGE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10488370 ↗MalfunctionJun 12, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
ADDITIONAL INFORMATION WAS RECEIVED 01JUL2020. THE RADIAL ARTERY WAS UP SIZED IN ORDER TO USE THE SLENGUIDE. THE R2P SLENGUIDE WAS USED TO REPLACE THE R2P SHEATH IMMEDIATELY AFTER THE PATIENT COMPLAINED OF PAIN. ARTERIAL SPASM MIGHT BE A POSSIBLE REASON THE PHYSICIAN WAS UNABLE TO PASS THE R2P AROUND THE SUBCLAVIAN ARTERY.
Patient problems: Blood Loss; Pain
MAUDE report 10148132 ↗MalfunctionApr 22, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
THE USER FACILITY REPORTED THAT THE R2P DESTINATION SL GUIDING SHEATH WAS USED FOR A SEVERELY CURVED ILIAC. THE SENRI BALLOON CATHETER COULD NOT GO THROUGH THE GUIDING SHEATH. BOTH THE BALLOON CATHETER AND THE GUIDING SHEATH WERE WITHDRAWN TO BE CHECKED, AND A SLIGHT KINK WAS OBSERVED IN THE SHEATH. THE DEVICE WAS NOT USED AND WAS REPLACED WITH ANOTHER GUIDING SHEATH TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.
Patient problems: Blood Loss
MAUDE report 9985550 ↗MalfunctionMar 19, 2020Difficult to Insert; Difficult to Insert
THE USER FACILITY REPORTED THAT A 4FR SHEATH WAS USED TO PUNCTURE THE RADIAL ARTERY, AND THEN THE R2P DESTINATION SL GUIDING SHEATH WAS INSERTED INTO THE ARTERY. WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE GUIDING SHEATH TO THE DESCENDING AORTA, THE GUIDING SHEATH DID NOT GO THROUGH AROUND THE BRACHIOCEPHALIC ARTERY PROBABLY DUE TO THE MEANDERING OF THE ARTERY AND DID NOT ADVANCE ANYMORE. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH ANOTHER R2P DESTINATION SL GUIDING SHEATH, WHICH WENT THROUGH THE ARTERY WITHOUT PROBLEM. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. BLOOD LOSS WAS LESS THAN 250CC'S.
Patient problems: Blood Loss
MAUDE report 9853265 ↗InjuryFeb 26, 2020Difficult to Advance; Difficult to Advance
THE USER FACILITY REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE R2P DESTINATION SL GUIDING SHEATH INTO THE ARTERY USING A RETROGRADE APPROACH, THE GUIDING SHEATH DID NOT GO THROUGH THE ARTERY DUE TO SEVERE STENOSIS. AFTER THAT, THE PUNCTURE SITE WAS CHANGED. THE GUIDING SHEATH WAS NOT USED AND REPLACED WITH A COMPETITOR'S GUIDING SHEATH, WHICH WAS INSERTED WITHOUT PROBLEM. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY A COMPETITOR'S DEVICE. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE BLOOD LOSS WAS LESS THAN 250CC. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.
Patient problems: Blood Loss
MAUDE report 9758426 ↗MalfunctionJan 24, 2020Difficult to Advance; Difficult to Advance
THE USER FACILITY REPORTED THAT THEY WERE UNABLE TO ADVANCE THE R2P DESTINATION SLENDER DEVICE. THE PHYSICIAN INSERTED THE 150CM-LONG DEVICE INTO THE RADIAL ARTERY. ON THE WAY TO THE TARGET SITE, IT BECAME HARD FOR THE PHYSICIAN TO ADVANCE THE DEVICE IN THE SUPERFICIAL FEMORAL ARTERY AND THE PHYSICIAN COULD NOT PUSH THE DEVICE THROUGH THE SUPERFICIAL FEMORAL ARTERY ANY FURTHER. THE PHYSICIAN MANAGED TO CONTINUE THE PROCEDURE AND SUCCESSFULLY COMPLETED THE PROCEDURE. THE PHYSICIAN WISHED TO ADVANCE THE DEVICE UP TO THE MORE DISTAL SECTION. THE PATIENT HAD NO HEALTH DAMAGE. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED DEVICE.
Patient problems: Blood Loss
MAUDE report 9626963 ↗MalfunctionNov 7, 2019Separation Problem; Separation Problem
THE USER FACILITY REPORTED THAT WHEN THEY WERE INSERTING THE SHEATH INTO THE PATIENT'S ARTERY THE DILATOR WOULD NOT STAY LOCKED IN PLACE IN THE SHEATH. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 14OCT2019. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC RUNOFF. A SECOND TERUMO SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9292901 ↗MalfunctionSep 18, 2019Leak/Splash; Leak/Splash
THE USER FACILITY REPORTED THAT R2P VALVE ON THE SHEATH WAS LEAKING DURING THE CASE. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 27AUG2019. THE PROCEDURE PERFORMED WAS AN ARTERIOGRAM. THE DEVICE WAS USED TO COMPLETE THE CASE. THE BLOOD LOSS WAS LESS THAN 250CC'S.
Patient problems: Blood Loss
MAUDE report 9083784 ↗MalfunctionJul 19, 2019Material Deformation; Material Deformation
THE USER FACILITY REPORTED THAT A KINK WAS OBSERVED IN THE R2P DESTINATION SHEATH DURING THE PROCEDURE USING A RADIAL ARTERY APPROACH. THE DEVICE WAS NOT USED AND ANOTHER R2P DESTINATION SL DEVICE WAS USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY THE SECOND DEVICE. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8808431 ↗InjuryOct 5, 2018Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT WHILE INSERTING THE R2PSHEATH OVER THE WIRE IN THE RADIAL ARTERY THERE WAS A LOT OF RESISTANCE FROM SPASM. THE DOCTOR PROCEEDED TO PUSH THE SHEATH IN, THE COILS BEGAN TO GET CLOSER TOGETHER AND ABSORB THE FORCE. THE BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC'S. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS TO ABANDONED RADIAL ACCESS AND GO WITH FEMORAL ACCESS TO COMPLETE THE PROCEDURE.
Patient problems: Blood Loss
MAUDE report 7938110 ↗MalfunctionSep 10, 2018Difficult to Remove; Difficult to Remove
THE USER FACILITY REPORTED THAT UPON REMOVAL OF THE DESTINATION SLENDER, IT WAS VERY DIFFICULT TO EXTRACT, HOWEVER, WAS ULTIMATELY ABLE TO REMOVE THE DESTINATION SLENDER. IT WAS A LEFT RADIAL ACCESS, ANGIOGRAM, AND IT WAS DECIDED TO TREAT THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) WITH DIAMONDBACK ATHERECTOMY, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, WHICH WAS SUCCESSFUL. THE PROCEDURE OUTCOME WAS SUCCESSFUL, AND THE PATIENT RECOVERED AND WAS IN STABLE CONDITION. DUE TO EXTRACTION, THE DESTINATION SLENDER HAS STRETCHED SOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7859368 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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