HI-TORQUE WIGGLE 22299M-W2Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648079719), received between Sep 27, 2019 and Feb 2, 2024 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024

  THE DISTAL TIP OF A CORONARY WIRE (WIGGLE WIRE) BROKE OFF INSIDE OF A CORONARY ARTERY. THE TEAM TRIED TO MULTIPLE TECHNIQUES TO REMOVE THE WIRE, WHICH WERE ALL UNSUCCESSFUL. IT WAS DEEMED THAT IT WOULD NOT HARM THE PATIENT GOING FORWARD, AND IT WAS LEFT WITHIN THE PATIENT AND THE PROCEDURE ENDED. THE WIRE WAS SAVED AND WILL BE SENT BACK TO THE VENDOR TO DETERMINE A POTENTIAL CAUSE OF THE FAILURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18629390 ↗
• InjuryOct 10, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH CORONARY PROTECTION IN THE BRANCH OF RAMUS INTERMEDIUS ARTERY WITHOUT CALCIFICATION. THE HI-TORQUE (HT) WIGGLE GUIDE WIRE WAS ADVANCED WITHOUT RESISTANCE, HOWEVER, THE TIP BROKE OFF INSIDE THE ANATOMY. PER THE PHYSICIAN, THE CAUSE OF FRACTURE WAS LIKELY CONTRIBUTED BY HEART BEAT CAUSING BACK AND FORTH SHEERING AT THE LOCATION OF A BIFURCATION WHEN THE WIRE TIP WAS PARKED IN A SIDE BRANCH. ATTEMPTS WERE MADE TO RETRIEVE THE TIP USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. THE SEPARATED PORTION WAS LEFT IN THE ANATOMY FIXED IN THE SIDE BRANCH, NOT FREE FLOATING, AND NO FILAMENTS HANGING OUT. THERE WAS UP TO AN HOUR OF ADDITIONAL PROCEDURAL TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17905500 ↗
• MalfunctionJul 13, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS AND 99% STENOSED. THE WIGGLE GUIDE WIRE FAILED TO CROSS THE DISTAL PART OF THE TARGET LESION. RESISTANCE WAS ALSO MET WITH THE LESION DURING REMOVAL OF THE GUIDE WIRE. ANOTHER GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317856 ↗
• MalfunctionJan 1, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A NON-ABBOTT GUIDE WIRE FIRST FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND WAS REPLACED WITH A WIGGLE GUIDE WIRE TO BE USED WITH A NON-ABBOTT GUIDE CATHETER EXTENSION; HOWEVER, THE WIGGLE GUIDE WIRE WAS DIFFICULT TO ADVANCE WITH AND SEEMED STUCK IN THE NON-ABBOTT GUIDE CATHETER EXTENSION. A NON-ABBOTT GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13137721 ↗
• InjuryFeb 16, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH MILD CALCIFICATION, HEAVY TORTUOSITY, AND 90% STENOSIS IN THE LEFT ATRIOVENTRICULAR ARTERY. A 2.5 X 23 MM XIENCE SKYPOINT STENT WAS IMPLANTED AND NO ISSUES WERE NOTED DURING THE REMOVAL OF THE STENT DELIVERY SYSTEM. THE HT WIGGLE GUIDE WIRE BECAME STUCK WITH THE LESION DURING THE REMOVAL. THE GUIDE WIRE WAS REMOVED BY DELIVERING A BALLOON AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT GUIDE WIRE. THERE WAS NO DAMAGE NOTED WITH THE STENT AFTER THE GUIDE WIRE WAS REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334466 ↗
• InjuryNov 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. AN UNSPECIFIED BALLOON CATHETER WAS USED WITH A WIGGLE GUIDE WIRE WITH NO RESISTANCE NOTED. DURING REMOVAL WITHOUT RESISTANCE, THE TIP OF THE GUIDE WIRE SEPARATED, SO AN UNSPECIFIED STENT WAS USED TO EMBED THE SEPARATED PORTION. THE PATIENT WAS FINE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10773339 ↗
• MalfunctionAug 11, 2020Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 014 WIGGLE GUIDE WIRE WAS ADVANCING TO THE LESION; HOWEVER, THE GUIDE WIRE COULD NOT CROSS TO THE TARGET LESION DUE TO ANATOMY. AFTER REMOVING THE GUIDE WIRE, IT WAS OBSERVED THAT THE TIP WAS BROKEN. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393758 ↗
• InjuryMar 31, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE DISTAL OBTUSE MARGINAL ARTERY. THE WIGGLE GUIDE WIRE WAS USED AND DURING THE PROCEDURE, THE TIP OF THE WIGGLE WIRE BROKE OFF IN THE PATIENT ANATOMY. THE SEPARATED TIP COULD NOT BE REMOVED AND REMAINS IN THE PATIENT ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9907282 ↗
• InjurySep 27, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  INFORMATION RECEIVED VIA USER FACILITY MEDWATCH: WHEN ATTEMPTED TO REMOVE WIRE, THE TIP BROKE OFF AND BECAME ENTRAPPED BEHIND COVERED STENT. PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT EVENT AND RECOVERY. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PROCEDURE WAS TO TREAT A FREE PERFORATION IN THE MID RIGHT CORONARY ARTERY (RCA). THE WIGGLE GUIDE WIRE WAS TRAPPED WHEN A GRAFTMASTER COVERED STENT WAS IMPLANTED. THE PERFORATION WAS SEALED. WHEN ATTEMPTING TO REMOVE THE WIRE THERE WAS SIGNIFICANT RESISTANCE AND THE TIP DETACHED. THE TIP WAS EMBEDDED TO THE VESSEL WALL BY THE USE OF AN ADDITIONAL STENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9132134 ↗