Destino Reach Steerable Guiding Sheath DCR1207122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672007430), received between Apr 26, 2018 and Dec 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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.

• MalfunctionDec 29, 2021Difficult to Advance; Air/Gas in Device; Difficult to Advance; Air/Gas in Device

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A CRYOABLATION PROCEDURE THE DOCTOR PERFORMED THE TRANSSEPTAL PUNCTURE WITH AN ABBOTT SL SHEATH IN COMBINATION WITH A TRANSSEPTAL NEEDLE. THE ABBOTT SL SHEATH AND THE TRANSSEPTAL NEEDLE WERE REMOVED AFTER THE TRANSSEPTAL PUNCTURE, HOWEVER, THE GUIDEWIRE WAS LEFT IN PLACE TO GUIDE THE STEERABLE SHEATH TO THE LEFT ATRIUM. THE DOCTOR STARTED TO PREPARE THE DESTINO REACH AND FLUSHED THE SHEATH AND DILATOR. THE DILATOR WAS ALSO MOISTENED FOR A SMOOTH INSERTION OF THE DILATOR INTO THE SHEATH. DURING THE INSERTION OF THE DILATOR INTO THE STEERABLE SHEATH THE DOCTOR RECOGNIZED THAT IT WAS EXTREMELY DIFFICULT TO INSERT THE DILATOR INTO THE STEERABLE SHEATH. IT WAS NECESSARY TO PUSH THE DILATOR WITH PRESSURE INTO THE SHEATH. AFTER PREPARING THE DILATOR AND THE STEERABLE SHEATH THE PRODUCT WAS INSERTED OVER THE GUIDEWIRE TO THE LEFT ATRIUM OF THE PATIENT. AFTER REACHING THE CORRECT POSITION IN THE LEFT ATRIUM THE DOCTOR REMOVED THE DILATOR FROM THE SHEATH. DURING THE REMOVAL OF THE DILATOR THE DOCTOR HAD DIFFICULTIES AND HAD TO USE FORCE TO PULL THE DILATOR OUT OF THE SHEATH. AFTER REMOVING THE DILATOR THE DOCTOR RECOGNIZED A BUBBLE OR A FOREIGN MATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13108691 ↗
• MalfunctionApr 26, 2018Break; Mechanical Problem; Material Separation; Break; Mechanical Problem; Material Separation

  DURING AN AFIB CRYO PROCEDURE ON (B)(6) 2018 IT WAS REPORTED THAT THERE WERE ISSUES WITH TWO DESTINO REACH 12F STEERABLE GUIDING SHEATHS. THE PHYSICIAN MENTIONED THAT THE FIRST REACH STEERING MECHANISM WENT OUT AFTER ACCESSING THE THIRD VEIN. THE SHEATH STOPPED DEFLECTING WHEN THE HANDLE WAS TWISTED. THE SECOND REACH, SAME LOT NUMBER, SNAPPED AFTER IT WAS INSERTED. THIS SECOND REACH HAD BEEN TESTED OUTSIDE THE PATIENT PRIOR TO PROCEDURE AND IT HAD WORKED WITH NO ISSUE OBSERVED. A THIRD REACH STEERABLE GUIDING SHEATH WAS AVAILABLE AND WORKED WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED AND NO CAUSE FOR CONCERN OR INJURY TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED. THE PRODUCTS IN QUESTION HAVE BEEN RETURNED AND ARE IN PROCESS OF EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466831 ↗