Destino Twist Steerable Guiding Sheath DST1207122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672007423), received between Jan 26, 2017 and May 2, 2019 — classified as 2 malfunctions.

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

• MalfunctionMay 2, 2019Break; Mechanical Problem; Break; Mechanical Problem

  THE CUSTOMER REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WHILE DEFLECTING SHEATH, SHEATH SNAPPED AND THEN WAS NO LONGER ABLE TO BE DEFLECTED. THE DEVICE WAS INSIDE THE PATIENT WHEN THE DEVICE BROKE, HOWEVER, THERE WAS NO APPARENT INJURY. IT WAS REPLACED, THE MECHANISM ON SECOND SHEATH ALSO FAILED. SECOND SHEATH HAS VISIBLE EXTERNALIZED WIRE FROM DISTAL TIP OF SHEATH WHEN REMOVED FROM BODY. THE CASE WAS COMPLETED WITH A COMPETITOR'S DEVICE. THERE WAS DELAY IN THE PROCEDURE. THE FIRST SHEATH ABOUT AN HOUR, THE SECOND SHEATH MINUTES, THEY WERE BEING USED FOR RIGHT LOWER PULMONARY VEIN (RLPV). SHEATH ISSUE RECOGNITION, REMOVAL AND EXCHANGE, FLUSHING/REFLUSHING OF SHEATHS AND CRYOBALLOON - APPROXIMATELY 15-20 MINUTES FOR EACH INSTANCE. THE PHYSICIAN REPORTED NO MEDICAL INTERVENTION OR ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575476 ↗
• MalfunctionJan 26, 2017Break; Break

  CUSTOMER REPORTED SNAPPED UPON RIGHT INFERIOR DEFLECTOR THE SHEATH MECHANISM. ON DECEMBER 18, 2015, OSCOR INC. REQUESTED ADDITIONAL INFORMATION. ON JAN 4, 2016, THE CUSTOMER PROVIDED NEW INFORMATION: DID THE HANDLE SNAP AND THUS THE DEVICE WOULD NOT DEFLECT ANYMORE? - CORRECT. WHAT TYPE OF PROCEDURE WAS BEING PERFORMED.- PULMONARY VEIN ISOLATION. DID THIS OCCUR DURING USE?-YES. WHAT DID THE DOCTOR DO FOLLOWING THIS OCCURRENCE?- REMOVED THE DEVICE, REPLACED IT WITH ANOTHER DESTINO FROM THE SAME BATCH NUMBER. HOW WAS THE PROCEDURE COMPLETED?- WITH THE REPLACEMENT DESTINO. WAS THERE A CONCERN FOR PATIENT INJURY?-NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6281602 ↗

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)