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SureFlex Steerable Guiding Sheath TSK85-32-BD-71M (UDI 00685447001683)Recalls & reported problems

Baylis Médicale Cie Inc · SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447001683), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pericardial Effusion1

Recent adverse event reports

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

  • InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AFTER COMPLETION OF A PROCEDURE IN WHICH THE SUREFLEX STEERABLE GUIDING SHEATH KIT WAS USED, A PERICARDIAL EFFUSION OCCURRED. IT WAS NOTED THAT THE PATIENT HAD A ROTATED CARDIAC ANATOMY WITH PERSISTENT ATRIAL FIBRILLATION (AF) AND THE LEFT ATRIUM (LA) WAS DESCRIBED AS LARGE. THE PHYSICIAN ENGAGED THE INTERATRIAL SEPTUM WITH THE BRK NEEDLE THROUGH THE SUREFLEX SHEATH. AFTER MULTIPLE EXTENSIONS OF THE NEEDLE, TRANSSEPTAL ACCESS WAS OBTAINED. THE SUREFLEX DILATOR FOLLOWED THE NEEDLE INTO THE LA BUT THE SHEATH WAS UNABLE TO BE ADVANCED SMOOTHLY. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN MAINTAINED TRANSSEPTAL ACCESS WITH A J-WIRE AND WITHDREW THE SUREFLEX SHEATH FROM THE BODY. THE PHYSICIAN ATTEMPTED TO PLACE A HEARTSPAN FIXED CURVE SHEATH OVER THE WIRE INTO THE LA BUT IT WAS UNABLE TO BE ADVANCED. HE REMOVED THE HEARTSPAN AND USED A LAMP 45 OVER THE J-WIRE, WHICH WAS ABLE TO BE ADVANCED TO THE LA. THE PHYSICIAN ATTEMPTED AGAIN TO ACCESS WITH THE SUREFLEX. THE PHYSICIAN LOADED THE BRK THROUGH AND ENGAGED THE SEPTUM AT A LOCATION CLOSE TO THE FIRST TRANSSEPTAL PUNCTURE. ON THIS ATTEMPT, THE BRK PUNCTURED WITH EASE AND THE SUREFLEX DILATOR AND SHEATH CROSSED SMOOTHLY INTO THE LA. THE PHYSIC

    Patient problems: Pericardial Effusion

    MAUDE report 9182672 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.