Destino Reach Steerable Guiding Sheath DCR0857717Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672007225), received between Dec 5, 2018 and Dec 19, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2018Leak/Splash; Leak/Splash

  ON NOVEMBER 29, 2018 IT WAS REPORTED THE SHEATH INITIALLY WAS USED WITH AN ORION MAPPING CATHETER. DURING THE PROCEDURE, THE MAPPING CATHETER HAD TO BE CHANGED. AFTER REMOVAL OF THE CATHETER, THE DESTINO WAS ASPIRATED AT THE VALVE TO FLUSH THE SHEATH PRIOR TO INSERTING THE NEW MAPPING CATHETER. DESPITE PREVIOUS ASPIRATION, THIS IRRIGATION PRODUCED AIR EMBOLISM IN THE PATIENT. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 17, 2018: THIS DESTINO REACH WAS USED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. THE SAME DESTINO REACH WAS USED IN THE ONGOING PROCEDURE, THE DESTINO REACH WAS IN USE FOR APPROXIMATELY TEN (10) MINUTES. THE SHEATH WAS NOT BEING DEFLECTED WHEN THE EVENT OCCURRED. A DEVICE WAS INSERTED THROUGH THE HEMOSTATIC VALVE WHEN THE EVENT OCCURRED. A GUIDEWIRE WAS BEING USED WHEN THE EVENT OCCURRED. WHEN THE EVENT OCCURRED, THE DESTINO REACH WAS NOT BEING USED IN A TORTUOUS PATH. DESPITE THE SYMPTOMS DUE TO THE AIR EMBOLISM WHICH WAS TREATED IMMEDIATELY AND SUCCESSFULLY, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. IT WAS REPORTED THERE WAS NO EXTENDED HOSPITALIZATION FOR THE PATIENT.

  Patient problems: Air Embolism; No Known Impact Or Consequence To Patient

  MAUDE report 8181192 ↗
• MalfunctionDec 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PVI TRANSSEPTAL PUNCTION, DILATOR HAS BEEN MADE WET WITH SALINE SOLUTION AND PUT INTO FLUSHED SHEATHS. AFTER DEAERATION TROUGH SIDE PORT (ASPIRATION WITH SYRINGE) DILATOR HAS BEEN DEAERATED WITH SLOW ASPIRATION OF BLOOD AND AFTERWARDS FLUSHED. DURING INSERTION OF THE TRANSSEPTAL NEEDLE NO RETURN FLOW OF LIQUID FROM DILATOR WAS NOTICED (WHICH IS USUAL FOR "AGILIS" WHICH HOSPITAL NORMALLY USE). DEAERATION AND FLUSHING HAS BEEN REPEATED THREE TIMES BUT ALWAYS WITH SAME RESULT. PHYSICIAN DECIDED TO SWITCH TO "AGILIS" AS HE SAW A POTENTIAL HIGHER RISK OF AIR EMBOLISM. PHYSICIAN ALSO NOTICED THAT HE FEELS THAT THE CONNECTOR FOR THE SYRINGE OF THE DILATATOR IS BIGGER THAN FROM OTHER PRODUCTS HE USED BEFORE. AS PER ADDITIONAL INFORMATION WHEN THE NEEDLE IS INSERTED IN THE DILATOR, THE SALINE SOLUTION IS PUSHED ASIDE AND ESCAPES THROUGH THE PROXIMAL END OF THE DILATOR, PHYSICIAN DID NOT SEE THIS EFFECT AND WAS WORRIED THAT THE DILATOR MIGHT NOT BE AIR FREE. THE PHYSICIAN COMMENTED THAT IT MIGHT BE DUE TO THE PATIENT AND MAYBE NOT THE SHEATH. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8135160 ↗