HI-TORQUE FLOPPY 22339MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648080098), received between Feb 9, 2018 and Mar 30, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2023Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE .014 HT FLOPPY II GUIDEWIRE (GW) WAS USED IN A STENTING PROCEDURE; HOWEVER, DURING REMOVAL RESISTANCE WAS NOTED WITH A NON-ABBOTT GUIDE CATHETER AND THE TIP GW BECOME SEPARATED. REPORTEDLY, THE TIP BECAME EMBEDDED AND TRAPPED BETWEEN THE STENT AND THE VESSEL. ATTEMPTS WERE MADE WITH A SNARE DEVICE TO REMOVE THE DETACHED TIP; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL. THE SEPARATED TIP REMAINS IN THE PATIENT. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16644453 ↗
• InjuryApr 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED RIGHT CORONARY ARTERY. DURING USE OF A .014 HT FLOPPY GUIDE WIRE, IT PERFORATED A VESSEL. HOWEVER, IT IS UNKNOWN WHEN THE PERFORATION OCCURRED; IF DURING ADVANCEMENT OR REMOVAL. THE PERFORATION WAS TREATED WITH AN UNSPECIFIED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 11665046 ↗
• InjuryFeb 9, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH A NEW NON-ABBOTT DRUG ELUTING STENT ON A PREVIOUSLY IMPLANTED STENT IN THE RIGHT CORONARY ARTERY. A HIGH-TORQUE (HT) FLOPPY II GUIDE WIRE AND AN UNKNOWN GUIDE WIRE WERE ADVANCED AS BUDDY WIRES; HOWEVER, THE UNKNOWN GUIDE WIRE WAS REMOVED FROM THE ANATOMY BEFORE THE NEW STENT WAS DEPLOYED. THE HT FLOPPY GUIDE WIRE WAS BETWEEN THE OLD STENT AND THE NEW STENT AND WHEN IT WAS PULLED BACK GENTLY THE TIP SEPARATED. THE TIP OF THE GUIDE WIRE WAS NOT ABLE TO BE PULLED BACK AND THE TIP SNARED; LESS THAN 1MM TIP WAS LEFT SANDWICHED AGAINST THE VESSEL WALL IN BETWEEN THE OLD STENT AND NEW STENT. FLOW WAS GOOD AND THE PATIENT HAD NO CHEST PAIN, NO EKG CHANGES, AND CINEANGIOGRAM AFTER GIVING INTRACORONARY NITROGLYCERIN SHOWED EXCELLENT MID FLOW DISTALLY. THE PATIENT IS DOING WELL AND WAS ADVISED TO CONTINUE ASPIRIN, PLAVIX, AND DUAL ANTIPLATELET THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7262020 ↗