Destino Reach Steerable Guiding Sheath DCR1007317Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672007621), received between Jun 27, 2022 and Jun 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Jam” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A 59 YEAR OLD MALE, WEIGHING 69 KILOGRAMS UNDERWENT A STENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE ARTERIA MESENTERICA SUPERIOR (AMS) PROCEDURE, USING TRANSFEMORAL ACCESS. AFTER TRYING TO INSERT THE STENT (VBX GORE VIABAHN 8-59), THE CURVE OF SHEATH COULD NOT BE DEFLECTED ANYMORE. THE DOCTOR EXCHANGED THE STEERABLE SHEATH, USING ANOTHER DST0707517 MODEL AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO EXTENDED HOSPITALIZATION OR ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED, HOWEVER, THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. THE PATIENT IS FINE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828124 ↗