THUNDER® THNDR190S (UDI 00643169453029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169453029), received between Apr 13, 2017 and Aug 10, 2023 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER AND ONE THUNDER GUIDE WIRE WERE USED TO TREAT THE RENAL ARTERIES. DURING THE PROCEDURE THE PATIENT SUFFERED FROM A VASOVAGAL RESPONSE AND THE PATIENTS HEART STOPPED (ASYSTOLE) FOR 10 SECONDS. ATROPINE WAS ADMINISTERED. THE PATIENT IS RECOVERING. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER OR THUNDER GUIDE WIRE USED DURING THE PROCEDURE.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 17496990 ↗
• MalfunctionJul 5, 2022Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE, ONE THUNDER GUIDEWIRE WAS USED. IT WAS REPORTED THAT AFTER REMOVING THE WIRE FROM THE PATIENT A SLIGHT FRACTURE TOWARDS THE END OF THE GUIDE WIRE WAS NOTED. NO INTERVENTION WAS REQUIRED. THERE WAS NO IMPACT REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14913979 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONLY SYMPLICITY SPYRAL GUIDE CATHETER, ONE LAUNCHER GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE LEFT AND RIGHT RENAL ARTERIES. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED RETROSPECTIVE WIRE DISSECTION LOWER BRANCH ARTERY. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER AND THUNDER GUIDEWIRE USED DURING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 13285688 ↗
• InjuryJan 6, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RENAL DENERVATION PROCEDURE (RDN), ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDEWIRE WERE USED TO TREAT THE RENAL ARTERIES. THE DEVICES WERE USED IN THE PROCEDURE APPROXIMATELY FIVE MONTHS PAST THEIR EXPIRATION DATE. ON THE SAME DAY POST RDN PROCEDURE, PATIENT SUFFERED PERFORATION IDENTIFIED POST TREATMENT IN THE RIGHT RENAL ARTERY. THE PROCEDURE WAS COMPLETED AND PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Perforation

  MAUDE report 13176288 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER AND TWO THUNDER GUIDE WIRES WERE USED. ON THE SAME DAY POST PROCEDURE PATIENT SUFFERED FROM PERFORATION IN THE RENAL ARTERY. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER AND THUNDER GUIDE WIRES USED DURING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 12907153 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SYMPLICITY SPYRAL CATHETER, ONE LAUNCHER GUIDE CATHETER AND TWO THUNDER GUIDE WIRES WERE USED. ON THE SAME DAY POST PROCEDURE PATIENT SUFFERED FROM PERFORATION IN THE RENAL ARTERY. THERE IS NO REPORTED MALFUNCTION FOR THE LAUNCHER GUIDE CATHETER AND THUNDER GUIDE WIRES USED DURING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 12907145 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE SIMPLICITY SPYRAL CATHETER, ONE SHERPA GUIDE CATHETER AND ONE THUNDER GUIDE WIRE WERE USED TO TREAT THE LEFT AND RIGHT RENAL ARTERY. ON THE SAME DAY, DURING DENERVATION PROCEDURE, PATIENT SUFFERED FROM RENAL ATERIA DISSECTION WITH INFARCTION. THE EVENT WAS TREATED WITH MEDICATION AND THE PATIENT UNDERWENT A SURGICAL INTERVENTION. PATIENT RECOVERED.

  Patient problems: Vascular Dissection

  MAUDE report 12613460 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT PROCEDURE, A SYMPLICITY SPYRAL CATHETER WAS USED TO TREAT THE RIGHT AND LEFT RENAL ARTERIES. A SHERPA GUIDE CATHETER AND THREE THUNDER GUIDE WIRES WERE ALSO USED DURING THE PROCEDURE IT WAS REPORTED THAT DURING THE PROCEDURE PATIENT SUFFERED A DISSECTION IN THE LEFT RENAL BRANCH. IT WAS REPORTED THAT A GUIDEWIRE WENT IN TO THE BRANCH AND AT END OF THE CASE THE VESSEL APPEARED TO HAVE A DISSECTION. THE DISSECTION WAS WIRED AND THE FLOW WAS REESTABLISHED. THE BRANCH WAS ALSO TREATED WITH RDN. DISSECTION WAS NOTED PRIOR TO INSERT THE SPYRAL CATHETER. INVESTIGATOR ASSESSED THAT EVENT IS NOT RELATED TO STUDY DEVICE OR THERAPY BUT DEFINITELY RELATED TO PROCEDURE. SPONSOR ASSESSED THAT EVENT IS RELATED TO PROCEDURE AND POSSIBLY RELATED TO SPYRAL CATHETER AND NOT RELATED TO THE THERAPY. THE PATIENT IS RECOVERED WITHOUT SEQUELAE. THERE IS NO REPORTED MALFUNCTION FOR THE THUNDER GUIDE WIRES AND SHERPA GUIDE CATHETER USED DURING THE PROCEDURE.

  Patient problems: Intimal Dissection

  MAUDE report 9687182 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT PROCEDURE, A SYMPLICITY SPYRAL CATHETER WAS USED TO TREAT THE RIGHT AND LEFT RENAL ARTERIES. A SHERPA GUIDE CATHETER AND THREE THUNDER GUIDE WIRES WERE ALSO USED DURING THE PROCEDURE IT WAS REPORTED THAT DURING THE PROCEDURE PATIENT SUFFERED A DISSECTION IN THE LEFT RENAL BRANCH. IT WAS REPORTED THAT A GUIDEWIRE WENT IN TO THE BRANCH AND AT END OF THE CASE THE VESSEL APPEARED TO HAVE A DISSECTION. THE DISSECTION WAS WIRED AND THE FLOW WAS REESTABLISHED. THE BRANCH WAS ALSO TREATED WITH RDN. DISSECTION WAS NOTED PRIOR TO INSERT THE SPYRAL CATHETER. INVESTIGATOR ASSESSED THAT EVENT IS NOT RELATED TO STUDY DEVICE OR THERAPY BUT DEFINITELY RELATED TO PROCEDURE. SPONSOR ASSESSED THAT EVENT IS RELATED TO PROCEDURE AND POSSIBLY RELATED TO SPYRAL CATHETER AND NOT RELATED TO THE THERAPY. THE PATIENT IS RECOVERED WITHOUT SEQUELAE. THERE IS NO REPORTED MALFUNCTION FOR THE THUNDER GUIDE WIRES AND SHERPA GUIDE CATHETER USED DURING THE PROCEDURE.

  Patient problems: Intimal Dissection

  MAUDE report 9686873 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT PROCEDURE, A SYMPLICITY SPYRAL CATHETER WAS USED TO TREAT THE RIGHT AND LEFT RENAL ARTERIES. A SHERPA GUIDE CATHETER AND THREE THUNDER GUIDE WIRES WERE ALSO USED DURING THE PROCEDURE IT WAS REPORTED THAT DURING THE PROCEDURE PATIENT SUFFERED A DISSECTION IN THE LEFT RENAL BRANCH. IT WAS REPORTED THAT A GUIDEWIRE WENT IN TO THE BRANCH AND AT END OF THE CASE THE VESSEL APPEARED TO HAVE A DISSECTION. THE DISSECTION WAS WIRED AND THE FLOW WAS REESTABLISHED. THE BRANCH WAS ALSO TREATED WITH RDN. DISSECTION WAS NOTED PRIOR TO INSERT THE SPYRAL CATHETER. INVESTIGATOR ASSESSED THAT EVENT IS NOT RELATED TO STUDY DEVICE OR THERAPY BUT DEFINITELY RELATED TO PROCEDURE. SPONSOR ASSESSED THAT EVENT IS RELATED TO PROCEDURE AND POSSIBLY RELATED TO SPYRAL CATHETER AND NOT RELATED TO THE THERAPY. THE PATIENT IS RECOVERED WITHOUT SEQUELAE. THERE IS NO REPORTED MALFUNCTION FOR THE THUNDER GUIDE WIRES AND SHERPA GUIDE CATHETER USED DURING THE PROCEDURE.

  Patient problems: Intimal Dissection

  MAUDE report 9686871 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LEFT AND RIGHT RENAL ARTERIES WERE TREATED WITH A SPYRAL RENAL DENERVATION CATHETER. A THUNDER GUIDEWIRE WAS USED DURING THE DE NERVATION CASE AND A DISSECTION OCCURRED. THE MEDICAL ADVISOR OF THE STUDY ASSESSED THAT THE CAUSE WAS MOST LIKELY DUE TO VESSEL DISSECTION DUE TO A GUIDEWIRE. NO CHANGE IN PROCEDURE OR TREATMENT SPECIFIC TO THE DISSECTION WAS DONE.

  Patient problems: Vascular Dissection

  MAUDE report 6489271 ↗