Destino Twist Steerable Guiding Sheath DST0704509Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885672004125), received between Jun 26, 2018 and Jun 15, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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.

• MalfunctionJun 15, 2022Mechanical Jam; Output Problem

  ONE OF THE SUPPLIES OSCOR TWIST SHEARABLE SHEATH MALFUNCTIONED. THE DILATOR WOULDN'T ADVANCE INTO THE SHEATH, IT WAS STUCK.

  Patient problems: Insufficient Information

  MAUDE report 14694937 ↗
• MalfunctionSep 3, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  DURING AN EVAR CASE, THE OSCOR TWIST WAS UTILIZED FROM IPSILATERAL LIMB ACCESS, OVER THE FLOW DIVIDER TO DELIVER 035 REGULAR GLIDE WIRE INTO AN INDY SNARE TO ASSIST WITH CONTRA-LATERAL EVAR CANNULATION. THIS WAS SUCCESSFUL AND UNEVENTFUL. WHEN WE TRIED TO STRAIGHTEN THE OSCOR SHEATH, IT WOULD NOT STRAIGHTEN. IT MAINTAINED ITS CURVE. WE TRIED TO PASS A STIFF WIRE THROUGH IT, THIS WAS UNSUCCESSFUL. EVENTUALLY WERE ABLE TO PUSH A 14FR SENTRANT SHEATH OVER THE TWIST, AND PULL IT, IN ITS SEMI-CURVE SHAPE, INTO THE SENTRANT SHEATH AND RETRIEVE IT. ON RETRIEVAL THE DEVICE APPEARED TO HAVE CRACKED ITS DISTAL TIP. IT WAS RETRIEVED INTACT. IF WE DID NOT HAVE A SENTRANT SHEATH, TO ACT AS A CO-AXIAL RESHEATH MECHANISM, THIS WOULD HAVE LED TO POSSIBLE OPEN RETRIEVAL OF DEVICE. NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422694 ↗
• MalfunctionJan 19, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PROCEDURE SIDE PORT HAS COME OFF. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11195717 ↗
• MalfunctionDec 4, 2018Material Frayed

  WE OPENED AN OSCOR DESTINO TWIST, DST0704509, THEY STATED THAT AS THEY WENT TO USE IT, IT WAS FRAYED ON THE END. DEFECT WAS NOTED IMMEDIATELY PRIOR TO USE; WAS NOT USED ON THE PATIENT. AN IDENTICAL SHEATH WAS OBTAINED; HAD NO DEFECTS AND WAS SUCCESSFULLY USED ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128237 ↗
• MalfunctionJun 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED ON 11/05/2018: THE REPORTER WAS NOT SURE AT WHAT POINT DURING THE PROCEDURE THE EVENT OCCURRED. THE PROCEDURAL NOTE STATES: THE PROXIMAL FENESTRATED ENDOGRAFT WAS THEN SUCCESSFULLY DEPLOYED. FROM THE CONTRALATERAL FEMORAL ACCESS SITE, THE DISTAL PORTION OF THE PROXIMAL FENESTRATED DEVICE WAS SELECTIVELY CATHETERIZED. A LUNDERQUIST WIRE WAS ADVANCED INTO THE PROXIMAL DEVICE AND A 14 FRENCH SHEATH WAS ADVANCED OVER THIS STIFF WIRE INTO THE PROXIMAL DEVICE. THE VALVE OF THE 14 FRENCH SHEATH WAS THEN SEQUENTIALLY PUNCTURED. THE FENESTRATIONS AND TARGET ARTERIES WERE THEN SELECTIVELY CATHETERIZED USING A 7.0 FRENCH OSCOR TWIST CONFORMABLE SHEATH, QUICK CROSS CATHETER AND A GLIDEWIRE. ADDITIONALLY, THE SMA REQUIRED THE USE OF A PRO-GRATE MICROCATHETER AND A V 18 WIRE TO CROSS THE HIGH-GRADE STENOSIS AT THE ORIGIN OF THE SMA. WITH EACH INDIVIDUAL VESSEL CANNULATION, THE GLIDEWIRE WAS EXCHANGED FOR A ROSEN WIRE. THE QUICK CROSS CATHETER AND CONFORMABLE SHEATH WERE THEN SEQUENTIALLY REMOVED. THE CONFORMABLE SHEATH WAS LEFT IN THE LAST VESSEL CANNULATED WITH THE DILATOR IN PLACE. NEXT, THE CONSTRAINING WIRE AND PROXIMAL FIXATION STRUTS WERE DEPLOYED. THE P

  Patient problems: Aneurysm; No Information

  MAUDE report 7639175 ↗

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)