Destino Twist Steerable Guiding Sheath DST0705509Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885672004156), received between Apr 29, 2019 and Sep 6, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K140406); they may or may not involve this specific model.

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.

• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A BRANCHED ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE, AFTER INSERTING THE STEERABLE SHEATH INTO THE BODY OF THE PATIENT, ACCORDING TO THE DOCTOR, THERE SEEMED TO BE A LEAK BETWEEN THE SIDEPORT AND THE HANDLE OF THE STEERABLE SHEATH. AS A RESULT, THE BLOOD WAS RUNNING OUT OF THE SIDE OF THE HANDLE RETROGRADE. AN UNKNOWN MODEL AND LOT NUMBER OF A TERUMO GUIDEWIRE WAS USED IN CONJUNCTION WITH THE OSCOR STEERABLE SHEATH IN THIS PROCEDURE. THE PATIENT IS STABLE; THERE WAS NO ADVERSE IMPACT TO THE PATIENT OR THE USER. NO ADDITIONAL SURGICAL INTERVENTION NOR ANY EXTENDED HOSPITALIZATION WAS REQUIRED, HOWEVER THERE WAS AN APPROXIMATE 10-MINUTE DELAY. ANOTHER OSCOR STEERABLE SHEATH MODEL DST0705517 WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT IDENTIFICATION INFORMATION IS AVAILABLE. IT IS UNKNOWN IF THE PATIENT LOSS ANY BLOOD, OR IF THEY REQUIRED A BLOOD TRANSFUSION, AS THIS INFORMATION WAS NOT PROVIDED BY THE DOCTOR. THIS DESTINO TWIST WILL BE RETURNED FOR EVALUATION, HOWEVER, THE TERUMO GUIDEWIRE USED IN THIS PROCEDURE WILL NOT BE RETURNED FOR EVALUATION WITH THIS DESTINO TWIST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161627 ↗
• MalfunctionJul 11, 2022Fluid/Blood Leak; Mechanical Jam; Fluid/Blood Leak; Mechanical Jam

  IT WAS REPORTED THAT THE THREE UNITS ALL SHOWED THE SAME PROBLEMS. DURING A FEVAR CASE IT WAS NOTICED AT START THEY WERE NOT ABLE TO CLICK THE PUSHER INTO THE HANDLE, IN ALL THREE AFFECTED UNITS. WHEN CANNULATING A SIDEBRANCH AND TURNING THE ROTATING WHEEL TO ADJUST THE CURVE A "POP" WAS FELT IN THE HANDLE. THE ROTATING WHEEL WAS STILL FUNCTIONING BUT THE CONNECTION BETWEEN HANDLE AND CATHETER WAS NOT FUNCTIONING, FELT SEPARATED. WHEN TURNING THE HANDLE ITSELF TO ROTATE THE TIP LEFT/RIGHT THERE WAS NO ROTATION OF THE TIP, NEXT TO THIS THE HANDLE STARTING LEAKING AND WHEN INTRODUCING A BERENSTEIN CATHETER THEY WERE NOT ABLE TO ADVANCE. AFTER CANNULATING THE FIRST, SECOND AND THIRD BRANCH THEY EVERY TIME HAD TO OPEN AND USE A NEW UNIT. ADDITIONAL DEVICE USED IN COMBINATION WITH THE OSCOR PRODUCT DURING THE PROCEDURE COOK FEVAR CUSTOM MADE GRAFT, ACCESS SHEATH GORE DRYSEAL 20F. DUE TO EXTRA EXCHANGES OF NEW UNITS AND WORKING WITH THE DEFECTIVE UNITS, DELAY 60 MINUTES. THE FOURTH THAT WAS OPENED WAS A SIMILAR UNIT BUT WITH LOT NUMBER: DP-15026. THIS UNIT WORKED NORMAL IN THE SAME PATIENT. SINCE 2016 THE UMCG HAS USED AROUND 400 UNITS OF DESTINO TWIST. THE MAJORITY OF CASES WITH THE DES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982323 ↗
• MalfunctionMay 25, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE DILATOR WAS TOO SHORT, AND IT DID NOT FIT INTO THE SHEATH. THE REPORTED EVENT OCCURRED DURING THE PROCEDURE. THE PHYSICIAN USED A NEW DILATOR TO CONTINUE THE PROCEDURE. NO SERIOUS INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880578 ↗
• MalfunctionFeb 11, 2020Use of Device Problem

  PER SURGEON, THIS IS A CONFORMABLE "STEERABLE" GUIDING SHEATH, HOWEVER, THE MALFUNCTION OCCURRED WHEN HE ATTEMPTED TO STEER IT AND IT WOULD NOT. ANOTHER DEVICE WAS OPENED AND USED SUCCESSFULLY. THE SURGEON REQUESTS OSCOR REQUEST AND OBTAIN THE DEVICE FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693347 ↗
• InjuryApr 29, 2019Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER PROVIDED ADDITIONAL INFORMATION, STATING THERE WAS NO DEFLECTION ISSUE WITH THE TWO OSCOR DESTINO'S, THE CURVES WERE KINKED. THE CUSTOMER BELIEVES THE THIRD SHEATH, FROM THE COMPETITOR, ALSO KINKED. NO MEDICAL INTERVENTION OR ADDITIONAL SURGICAL PROCEDURE REPORTED. A SECOND PROCEDURE WAS RESCHEDULED, HOWEVER THE SPECIFIC DATE COULD NOT BE PROVIDED BY THE NURSE. THE CUSTOMER REPORTED THE PATIENT WAS SCHEDULED FOR ARTERIAL OCCLUSION, STENOSIS. IT WAS REPORTED THE DOCTOR INTRODUCED THE SHEATH AND WANTED TO STEER IT BUT IT DIDN'T WORK AS EXPECTED. IT SEEMED THAT THERE WAS A BLOCKAGE IN THE CURVE. HE HAD THE FEELING THAT THE CURVE KINKED UNDER LOW FORCE. AFTER THAT HE USED ANOTHER OSCOR DESTINO TWIST WITH THE SAME LOT NUMBER, THE PROBLEM OCCURRED AGAIN (THE NURSES DIDN'T KEEP THE DEVICE). THE DOCTOR TRIED A THIRD SHEATH, FROM ANOTHER COMPANY (COMPETITOR) WITHOUT BEING SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8562395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140406. One submission often covers many models, so check the product and lot details in each record.

• Z-0646-2022 · Dec 22, 2021 · Completed
  Destino Twist 14F (also branded as Guidestar 14F)