Guidezilla™ H7493924215050Recalls & reported problems

Summary

The FDA's MAUDE database contains 294 adverse event reports that list this exact device (DI 08714729839859), received between Apr 3, 2018 and Feb 21, 2023 — classified as 6 injuries, 288 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (84 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 294 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEZILLA WAS FRACTURED. A 5-IN-6 GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION, IT WAS NOTED THAT THE HYPOTUBE TRANSITION SECTION WAS FRACTURED WHEN THE PHYSICIAN WAS ABOUT TO TAKE OUT THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD POSTOPERATIVE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414542 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT DEVICE FRACTURE OCCURRED. THE TARGET LESION WAS IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. A GUIDEZILLA 145 GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE CATHETER OF THE GUIDEZILLA AND THE STEEL BEAM OF THE GUIDEWIRE FRACTURED DURING REMOVAL, AND THE USE WAS FINALLY ABANDONED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246447 ↗
• MalfunctionJan 26, 2023Break; Break

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS DELIVERED TO MAINTAIN THE SUPPORT FORCE OF THE STENT, IT WAS NOTED THAT THE JOINT PART AND THE CATHETER WAS FRACTURED 125CM FROM THE HUB. THE DEVICE WAS PULLED OUT DIRECTLY FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED AND, NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246283 ↗
• MalfunctionMar 8, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON 13FEB2022. IT WAS REPORTED THAT THE CATHETER WAS KINKED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE COLLAR WAS PARTIALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694437 ↗
• MalfunctionFeb 17, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JAN2022. IT WAS REPORTED THAT THE CATHETER BECAME KINKED. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE IN THE LEFT ANTERIOR DESCENDING ARTERY. AFTER THE PHYSICIAN OPENED THE PACKAGE, IT WAS FOUND THAT THE CONNECTION OF THE DELIVERY SHAFT AND THE ACCESS CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED COLLAR AND SHAFT PARTIAL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13551195 ↗
• MalfunctionJan 13, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22DEC2021. IT WAS REPORTED THAT THE CONNECTION BETWEEN THE DELIVERY SHAFT AND GUIDING CATHETER WAS KINKED. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE ON THE STENOSED AND TORTUOUS RIGHT CORONARY ARTERY. DURING PREPARATION, THE PHYSICIAN UNPACKED THE DEVICE AND FOUND THE CONNECTION PART BETWEEN THE DELIVERY SHAFT AND GUIDING CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COLLAR WAS PARTIALLY DETACHED, AND THE SHAFT WAS PARTIALLY DETACHED AND TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13255758 ↗
• MalfunctionJan 4, 2022Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A GUIDEZILLA WAS STUCK IN THE LESION. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS SCRATCHED AND STUCK IN THE LESION. THE DEVICE WAS REMOVED NORMALLY WITH THE ANCILLARY DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO INTERVENTION WAS DONE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13157049 ↗
• MalfunctionDec 16, 2021Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14DEC2021. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING ADVANCING AND THE DEVICE WAS LIFTED UP AFTER WITHDRAWAL. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE PROXIMAL END OF THE LEFT ANTERIOR DESCENDING ARTERY. A GUIDEZILLA 145 GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS NOTED THAT AS ADVANCING WITH SOME RESISTANCE, THE DEVICE COULD NOT CROSS THE COMPLEX LESION SITE, AND THE PHYSICIAN HAD TO REMOVE IT AND FOUND THE DEVICE WAS LIFTED UP. THE DEVICE WAS NOT USED DURING THE PROCEDURE AND IT WAS COMPLETED NORMALLY WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE COLLAR WAS PARTIALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023587 ↗
• MalfunctionNov 4, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE CATHETER WAS KINKED. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS KINKED AND COULD NOT BE DELIVERED INTO THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751828 ↗
• MalfunctionOct 19, 2021Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06OCT2021. IT WAS REPORTED THAT DIFFICULTY ADVANCING THROUGH CATHETER OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE WIRE LUMEN AND THERE WAS A BENT ON THE TIP OF THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT WAS SEPARATED FROM THE COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661458 ↗
• MalfunctionOct 13, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22SEP2021. IT WAS REPORTED THAT THE DEVICE WAS KINKED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 5-IN-6 GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE JOINT SEGMENT OF THE CATHETER WAS KINKED THUS, COULD NOT BE USED. THE CATHETER WAS THEN REPLACED WITH ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624358 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT THE SHAFT BREAK OCCURRED. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. UPON UNPACKING, THE CATHETER WAS FOUND TO BE BROKEN AT THE FRONT END OF THE CATHETER. THE OUTER PACKING AND CARRIER TUBE WAS INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495466 ↗
• InjuryJul 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER WAS FRACTURED AND PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THE MILDLY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT BRACHIAL ARTERY. A 5-IN-6 GUIDEZILLA CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING WITHDRAWAL OF THE DEVICE, IT WAS NOTED THAT THE ANTERIOR PART OF THE EXTENSION CATHETER WAS FRACTURED IN THE TARGET AREA. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO ANOTHER HOSPITAL FOR REMOVAL OF THE DEVICE VIA SURGICAL OPERATIONS. PHYSICIAN'S OPINION ON THE CAUSE OF THE FRACTURE WAS BECAUSE OF IMPROPER OPERATION. NO FURTHER PATIENT COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12139635 ↗
• MalfunctionJun 9, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE HAS BEEN COMPROMISED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A GUIDEZILLA CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE INNER PACKAGE WAS NOT SEALED. THE POSSIBILITY OF BACTERIAL CONTAMINATION WAS CONSIDERED, THUS THE PHYSICIAN CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969592 ↗
• MalfunctionApr 6, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22MAR2021. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. THE 90% STENOSED, 24MMX2.75MM, TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 5-IN-6 GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL SEPARATION AT THE SHAFT/COLLAR AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623451 ↗
• MalfunctionMar 26, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09MAR2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A COMPLETE SEPARATION AT THE COLLAR/SHAFT WITH THE PTFE PULLED OUT OF THE COLLAR, AND PARTIAL SEPARATION OF MATERIAL IN THE COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11575169 ↗
• MalfunctionMar 25, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10MAR2021. IT WAS REPORTED THAT THE TIP WAS KINKED. THE 85% STENOSED TARGET LESION AREA WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 145, 5-IN-6 GUIDEZILLA CATHETER GUIDE EXTENSION WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE GUIDECATHETER TIP WAS DAMAGED AND KINKED THROUGHOUT USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A SEPARATED COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570846 ↗
• MalfunctionMar 15, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26FEB2021. IT WAS REPORTED THAT THE GUIDEZILLA COULD NOT CROSS THE LESION. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND MILDLY CALCIFIED ANTERIOR DESCENDING ARTERY. A 5-IN-6 GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION DUE TO VESSEL TORTUOSITY AND MILD CALCIFICATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A PARTIAL SEPARATION AT THE SHAFT/COLLAR AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485770 ↗
• MalfunctionMar 2, 2021Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2021. IT WAS REPORTED THAT THE TIP OF THE GUIDEZILLA WAS KINKED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. A 5-IN-6 GUIDEZILLA CATHETER GUIDE EXTENSION WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS KINKED AND COULD NOT BE ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A COMPLETE SEPARATION AT THE COLLAR/SHAFT AREA OCCURRED WITH PART OF THE SHAFT STILL ATTACHED TO THE COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399578 ↗
• MalfunctionMar 1, 2021Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2021. IT WAS REPORTED THAT THE GUIDEZILLA COULD NOT ENTER THE GUIDE CATHETER. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 5-IN-6 GUIDEZILLA CATHETER GUIDE EXTENSION WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEZILLA COULD NOT ENTER THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A COMPLETE SEPARATION AT THE COLLAR/SHAFT AREA OCCURRED WITH THE PTFE PULLED OUT OF THE COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11393513 ↗
• MalfunctionFeb 23, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10FEB2021. IT WAS REPORTED THAT A GUIDEZILLA COULD NOT CROSS THE LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 5-IN-6 GUIDEZILLA CATHETER GUIDE EXTENSION WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A COMPLETE SEPARATION AT THE COLLAR/SHAFT AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366851 ↗
• MalfunctionFeb 16, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29JAN2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE 85% STENOSED, 23MMX2.2MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY. A 145 GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A COMPLETE SEPARATION OF THE DEVICE AT THE DISTAL EDGE OF THE COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333348 ↗
• MalfunctionFeb 10, 2021Break; Break

  IT WAS REPORTED THAT THE SHAFT BROKE. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DELIVERY PUSHER ROD BROKE UPON INSERTION INTO THE GUIDE CATHETER. THE DEVICE WAS REMOVED DIRECTLY FROM THE PATIENT WITH NO ADDITIONAL INTERVENTION NEEDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309552 ↗
• MalfunctionJan 25, 2021Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13JAN2021. IT WAS REPORTED THAT DEVICE WAS KINKED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE CONNECTION SECTION OF THE DEVICE WAS KINKED AND WAS THEN WITHDRAWN IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED COLLAR SEPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11223423 ↗
• MalfunctionJan 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COLLAR WAS FRACTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COLLAR WAS FRACTURED. THE DEVICE WAS SIMPLY PULLED OUT COMPLETELY FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11223268 ↗