HI-TORQUE WHISPER 1005359HJRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648037832), received between Feb 28, 2017 and Aug 20, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  VOLUNTARY MEDWATCH FORM (MW5110881) RECEIVED STATING: WHEN REMOVING THE WIRE, UPON PULLING BACK ON THE WHISPER WIRE, THE DISTAL WIRE TIP BROKE. FDA SAFETY REPORT ID# (B)(4). ADDITIONALLY, THE FOLLOWING INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 95% STENOSED LESION IN THE CIRCUMFLEX (CX) ARTERY. WHEN REMOVING THE 014 WHISPER GUIDE WIRE FROM THE ANATOMY, UPON PULLING BACK ON THE GUIDE WIRE, THE DISTAL TIP SEPARATED. A SNARE WAS USED TO REMOVE THE SEPARATED TIP FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262985 ↗
• MalfunctionMay 6, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED, LEFT SUPERIOR FEMORAL ARTERY (SFA). A 3CM 014 WHISPER GUIDE WIRE (GW) WAS ADVANCED INTO THE GUIDING CATHETER (GC) WITHOUT ISSUE. DURING REMOVAL, THE GW BECAME STUCK WITH THE NAVICROSS GC AND WAS UNABLE TO BE ADVANCED OR PULLED BACK. THE CATHETER AND GUIDE WIRE WERE REMOVED FROM THE ANATOMY AS ONE UNIT AND IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE HAD SEPARATED INSIDE OF THE CATHETER. A COMMAND GUIDE WIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784938 ↗
• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE RIGHT CAROTID ARTERY WHICH WAS REPORTED TO BE SEVERELY NARROWED AT 75% OR GREATER. A 7FR 90CM SHUTTLE SHEATH WHICH WAS PLACED IN THE PROXIMAL TO MID-SEGMENT OF THE RIGHT COMMON CAROTID ARTERY. IT SHOULD BE NOTED THAT THE PATIENT WAS NOT COOPERATIVE AND WAS CONSTANTLY MOVING, TALKING, AND COUGHING THROUGHOUT THE PROCEDURE. DURING ONE OF THE CRITICAL STEPS OF WIRE MANIPULATION AND ADVANCEMENT OF THE SHEATH THE PATIENT COUGH THEN TURNED THEIR HEAD, WHICH RESULTED IN A PERFORATION OF THE CAVERNOUS PORTION OF THE RIGHT INTERNAL CAROTID ARTERY BY A WHISPER GUIDE WIRE. FOLLOWING PRE-DILATATION, A 4.0X16MM GRAFTMASTER RX COVERED STENT SYSTEM WAS ADVANCED BUT FAILED TO CROSS DUE TO THE ANATOMY. THE COVERED STENT SYSTEM WAS REMOVED AND RE-ADVANCED, BUT AGAIN FAILED TO CROSS. A 7FR GUIDELINER SUPPORT CATHETER AND AN UNSPECIFIED DIAGONAL GUIDE WIRE WERE ADVANCED. THE 4.0X16MM COVERED STENT WAS DEPLOYED AT 17 ATMOSPHERES (ATMS) FOR 30 SECONDS. DUE TO THE PERFORATION LENGTH, A SECOND 4.0X16MM GRAFTMASTER RX COVERED STENT SYSTEM WAS ADVANCED INTO THE DISTAL SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY BUT JUST PROXIMAL TO THE ORIGIN OF

  Patient problems: Perforation

  MAUDE report 9306277 ↗
• InjuryOct 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. A WHISPER MS GUIDE WIRE WAS ADVANCED AND CROSSED THE TARGET LESION. HOWEVER, THE TIP BROKE OFF IN THE 1ST OBTUSE MARGINAL BRANCH. THE DEVICE WAS REMOVED, BUT THE SEPARATED TIP REMAINS IN THE PATIENT. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9145824 ↗
• InjuryApr 20, 2018Detachment Of Device Component; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY. A WHISPER GUIDE WIRE FAILED TO CROSS DUE TO THE ANATOMY. ABOUT 10CM OF THE TIP WIRE BROKE OFF IN THE ANATOMY DURING REMOVAL AND THE BROKEN TIP TWISTED, WHICH MADE IT IMPOSSIBLE TO REMOVE FROM THE ANATOMY, EVEN AFTER SEVERAL ATTEMPTS TO SNARE. THE TIP WAS LEFT IN THE PATIENT AND THE ANTERIOR TIBIALIS WAS NOT RE-VASCULARIZED. THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7448359 ↗
• InjuryApr 18, 2018Detachment Of Device Component

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE WAS BEING PERFORMED ON THE RIGHT FEMORAL ARTERY WITH A PERCLOSE PROGLIDE; HOWEVER, THE TIP OF A WHISPER GUIDE WIRE BROKE OFF IN THE PATIENT. THE GUIDE WIRE TIP WAS SUCCESSFULLY REMOVED WITH A SNARE DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441975 ↗
• InjuryFeb 28, 2017Detachment Of Device Component; Physical Resistance

  IT WAS REPORTED THAT A BALLOON DILATATION CATHETER (BDC) WAS BEING ADVANCED ON THE WHISPER GUIDE WIRE AND MET RESISTANCE WITH THE ANATOMY WHEN THE DOCTOR COULD NO LONGER FEEL THE GUIDE WIRE MOVEMENT DISTALLY. THE BDC WAS REMOVED WITH THE GUIDE WIRE WHEN IT WAS NOTICED THAT THE DISTAL TIP OF THE GUIDE WIRE HAD SEPARATED IN THE ANTERIOR TIBIAL ARTERY. A NON-ABBOTT FILTER WAS INSERTED TO REMOVE THE SEPARATED TIP FROM THE TIBIAL ARTERY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6364469 ↗