Guidezilla™ II H7493933515070Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 08714729939474), received between Sep 25, 2018 and Sep 9, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (13 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 24, 2019Terminated

   Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.

   Z-0578-2020 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Difficult to Remove; Difficult to Advance; Material Integrity Problem

  It was reported that withdrawal difficulty occurred.The 85% stenosed target lesion was located in the severely tortuous and moderately calcified left anterior descending artery. A 7F Guidezilla II guide extension catheter was selected for use. When the device was advanced through the proximal and curved segments of the target vessel, there was a significant increase in resistance, and it was difficult to cross the angulation. Abnormal tension was encountered during withdrawal of the catheter. Upon inspection, the catheter exhibited a collapsed and kinked distal tip. Further examination identified lumen narrowing and deformation. The procedure was completed with another of the same device. There were no patient complications, and the patient condition following the procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50682286 ↗
• MalfunctionAug 14, 2026Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50247512 ↗
• MalfunctionAug 12, 2026Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217374 ↗
• MalfunctionAug 6, 2026Break; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159151 ↗
• MalfunctionJun 10, 2026Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 79% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. THE 7F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO CONNECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR AND SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461081 ↗
• MalfunctionDec 29, 2025Nonstandard Device; Device-Device Incompatibility; Nonstandard Device; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A PATIENT WITH CHEST PAIN. A 7F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A LOT OF RESISTANCE WHEN ADVANCING THE 1.50MM ROTAPRO THROUGH THE GUIDEZILLA INTO THE PATIENT. AFTER SEVERAL FAILED ATTEMPTS, THE SYSTEM WAS REMOVED. THE ROTAPRO WAS PRE-LOADED WITHIN THE GUIDEZILLA AND DYNA-GLIDED BEFORE FURTHER INTRODUCTION OF THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918451 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT CATHETER ISSUES OCCURRED. THE TARGET LESION WAS LOCATED AT THE BIFURCATION OF THE DISTAL RIGHT CORONARY ARTERY. A 7F GUIDEZILLA WAS SELECTED FOR USE. A SYNERGY STENT WAS ADVANCED, AND A 2.50 X 20MM BALLOON WAS ADVANCED FOR PROTECTION. SIGNIFICANT DIFFICULTY WAS ENCOUNTERED WHILE USING THE GUIDEZILA, RESULTING IN BALLOON ENTRAPMENT AND FRACTURE. UPON REMOVAL OF THE WHOLE SYSTEM, THE STENT BECAME DAMAGED, AND THE GUIDEZILLA WAS RETRIEVED COMPLETELY DEFORMED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696708 ↗
• MalfunctionOct 21, 2025Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29SEP2025. IT WAS REPORTED THAT THE DEVICE COULD NOR CROSS THE LESION AND TIP DAMAGED OCCURRED. THE 20MM X 3.5MM IN DIAMETER, 90% STENOSED TARGET WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). A GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT CROSS THE LESION WHEN IT ENTERED. AFTER WITHDRAWAL, IT WAS FOUND THAT IT HAD KINK MARK AT THE TIP OF THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A PARTIAL COLLAR AND SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345920 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. A 7F GUIDEZILLA CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. IT WAS NOTED THAT THE CATHETER WAS DEFORMED, PARTIALLY OR COMPLETELY SEPARATED, AT ITS PROXIMAL END WHEN PASSING A BALLOON. THE DEVICE WAS SIMPLY PULLED OUT TO COMPLETELY REMOVE IT FROM THE PATIENT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398582 ↗
• MalfunctionJul 1, 2025Break; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Break; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED CORONARY LESION. A 7F GUIDEZILLA CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. THE DEVICE TIP WAS DEFORMED SIGNIFICANTLY AT THE PROXIMAL END, WHICH DAMAGED TWO ANGIOPLASTY BALLOONS. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT IN ONE PIECE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379178 ↗
• MalfunctionApr 9, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEZILLA WAS FRACTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERE CALCIFIED RIGHT CORONARY ARTERY. A 7F GUIDEZILLA II WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP WAS FRACTURED AND DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT IS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21809717 ↗
• MalfunctionMar 25, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 04MAR2025. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A GUIDEZILLA II, 7F WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT PASS THROUGH THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A PARTIAL COLLAR AND SHAFT SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692099 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED. A PATIENT EXPERIENCED A RENAL ARTERY DISSECTION, POTENTIALLY ASSOCIATED WITH THE USE OF THE 7 FR GUIDEZILLA II GUIDE CATHETER. THE PHYSICIAN CONFIRMED THROUGH LIVE FLUOROSCOPY IMAGING THAT A NON-BOSTON SCIENTIFIC CATHETER WAS NOT INTRODUCED INTO THE INFERIOR BRANCH OF THE RIGHT RENAL ARTERY. ONLY THE GUIDEWIRE AND GUIDEZILLA II CATHETER WERE PLACED IN THE INFERIOR BRANCH, WHERE THE DISSECTION OCCURRED. THE PHYSICIAN SUGGESTED THAT THE LIKELY CAUSE OF THE DISSECTION WAS THE FORCE APPLIED BY THE 7 FR GUIDEZILLA II GUIDE CATHETER AS IT NAVIGATED THE AREA WHERE THE INFERIOR BRANCH CURVED UPWARD. FOLLOWING AN UNSUCCESSFUL ANGIOPLASTY WITH A 2.5 X 15MM EMERGE BALLOON CATHETER TO TREAT THE DISSECTION, THE DISSECTION WAS TREATED BY PLACING TWO BOSTON SCIENTIFIC SYNERGY XD DRUG-ELUTING STENTS. THE FIRST STENT, A 3 X 8MM SYNERGY XD DES, WAS PLACED IN THE INFERIOR BRANCH OF THE RIGHT RENAL ARTERY, WHILE THE SECOND STENT, A 4 X 12MM SYNERGY XD DES, WAS POSITIONED FROM THE PROXIMAL PORTION OF THE INFERIOR BRANCH INTO THE MAIN BRANCH OF THE RIGHT RENAL ARTERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENTS CONDITION REMAINED STABLE. THEY WERE SUBSEQUENT

  Patient problems: Vascular Dissection

  MAUDE report 21471881 ↗
• MalfunctionFeb 12, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED. A 7F GUIDEZILLA II WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEZILLA II 7F DID NOT NAVIGATE PROPERLY THROUGH THE NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE CATHETER, EVEN AFTER REMOVING THE Y CONNECTOR. AFTER REMOVAL FROM THE PATIENT, THE GUIDEZILLA WAS TESTED AGAIN BUT CONTINUED TO FAIL TO PASS THROUGH THE CATHETER LUMEN. VISUAL INSPECTION DID NOT DETECT ANY DAMAGE TO EITHER THE NON-BSC GUIDE CATHETER OR THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE DEVICE FAILURE RESULTED IN A DELAY IN THE PROCEDURE, WHICH LED TO INCREASED RADIATION AND CONTRAST CONSUMPTION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED PARTIAL SEPARATIONS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21369247 ↗
• MalfunctionDec 6, 2024Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THAT A SHAFT HOLE OCCURRED. A 6F GUIDEZILLA CATHETER-GUIDE EXTENSION WAS SELECTED FOR USE. DURING THE PROCEDURE, PRIOR OF USING THE DEVICE, A HOLE WAS NOTED ON THE PROXIMAL SIDE OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865147 ↗
• MalfunctionJul 9, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP WAS SLIGHTLY TORN. A 7F GUIDEZILLA GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE USE WAS DISCONTINUED AS THE TIP WAS SLIGHTLY TORN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705260 ↗
• MalfunctionJul 2, 2024Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11JUN2024. IT WAS REPORTED THAT THE CATHETER WAS KINKED. THE 85% STENOSED 34MM X 3.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 7F GUIDEZILLA II 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. NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE SHAFT AND COLLAR WERE PARTIALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660975 ↗
• MalfunctionApr 11, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 7F GUIDEZILLA II WAS SELECTED FOR USE. DURING PROCEDURE, A RESISTANCE WITHIN THE GUIDE SEGMENT HAS OCCURRED. THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19092663 ↗
• InjuryFeb 27, 2024Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A GUIDEZILLA II, 7F GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, IT WAS NOTED THAT A NON-BSC BALLOON CATHETER, STENT, AND Y-SHAPED CONNECTOR'S DELIVERABILITY FOR LESION WAS POOR, ORBITAL ATHERECTOMY SYSTEM (OAS) WAS DELIVERED USING GUIDEZILLA UP TO LEFT MAIN CORONARY ARTERY SEGMENT OS. AFTER THAT TIME, THE PRESSURE BECAME DULL, AND WHEN THE BLOOD WAS REVERSED (DRAWING BLOOD WITH A SYRINGE), AIR GOT MIXED IN. WHEN THE NON-BSC BALLOON CATHETER DELIVERED USING THE GUIDEZILLA IN THE SAME WAY, THE SAME ISSUE OCCURRED, AS WELL AS IN DELIVERING THE NON-BSC STENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.

  Patient problems: Air Embolism

  MAUDE report 18788693 ↗
• MalfunctionOct 25, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE CATHETER BROKE. THE PATIENT PRESENTED WITH CHRONIC TOTAL OCCLUSION (CTO). THE PATIENT'S SUBCLAVIAN APPEARED TO BE TORTUOUS AND THE TAKEOFF OF THE SAPHENOUS VEIN GRAFT (SVG) WAS DIFFICULT TO ENGAGE. THE GUIDEZILLA GUIDE EXTENSION CATHETER WAS USED TO HELP WITH ENGAGEMENT IN THE MODERATELY TORTUOUS AND NON-CALCIFIED SVG RETROGRADE TO THE CTO RADIALLY. DURING THE PROCEDURE, THERE WAS DIFFICULTY GETTING A TRAPPER BALLOON THROUGH THE GUIDEZILLA TO TRAP OUT A MICROCATHETER. WHILE TRYING TO GET THE EQUIPMENT OUT, THE TRAPPER WAS STUCK. THE GUIDEZILLA BROKE NEAR THE TRANSITION COLLAR AND THE TRAPPER SHAFT ALSO BROKE. THE BALLOON WAS SUCCESSFULLY REMOVED AND AFTER SEVERAL TECHNIQUES WERE USED, THE GUIDEZILLA WAS ALSO ABLE TO BE REMOVED. THERE WAS DIFFICULTY WITH THE REST OF THE PROCEDURE, SO THE CTO WAS NEVER COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000521 ↗
• MalfunctionSep 11, 2023Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29AUG2023. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE GUIDEZILLA AND THE GUIDEZILLA FAILED TO CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A GUIDEZILLA II 7F GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS STENT DELIVERY FAILURE AND THE GUIDEZILLA COULD NOT CROSS THE LESION DUE TO ANGULATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS PARTIAL SHAFT DETACHMENT AT THE DISTAL END OF THE COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720591 ↗
• MalfunctionAug 1, 2023Difficult to Remove; Device Damaged by Another Device; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Device Damaged by Another Device; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEZILLA DAMAGED THE STENT. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS ARTERY. A 7F GUIDEZILLA II WAS SELECTED FOR USE. A NON-BOSTON SCIENTIFIC DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT WAS UNABLE TO CROSS THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO INSERT THE STENT THROUGH THE GUIDEZILLA GUIDE EXTENSION CATHETER, BUT THERE WAS RESISTANCE. WHEN AN ATTEMPT WAS MADE TO REMOVE THE STENT, THERE WAS STRONG RESISTANCE, AND THE STENT WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438369 ↗
• MalfunctionApr 20, 2023Device Damaged by Another Device; Device-Device Incompatibility; Device Damaged by Another Device; Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDEZILLA WAS DAMAGED AND A BALLOON RUPTURE OCCURRED WHEN THE DAMAGED PART WAS CROSSED. A 15MMX2.75MM WOLVERINE CORONARY CUTTING BALLOON AND A 7F GUIDEZILLA CATHETER-GUIDE EXTENSION WERE USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEZILLA IS SCRATCHED AND DAMAGED AND A BALLOON RUPTURE HAS OCCURRED WHEN THE DAMAGED PART WAS CROSSED. CONSEQUENTLY, IT WAS CONFIRMED THROUGH FLUOROSCOPY THAT THE COLLAR PART HAS COLLAPSED TOWARD THE LUMEN SIDE. THE BALLOON AND THE GUIDEZILLA WERE REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH THE GUIDEZILLA AND ANOTHER OF THE SAME BALLOON. NO COMPLICATIONS REPORTED AND THE PATIENT IS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781020 ↗
• MalfunctionApr 20, 2023Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED WITHIN THE GUIDE CATHETER. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE >80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 4.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. DURING REMOVAL, THE STENT CAME OFF THE BALLOON COMPLETELY WITHIN THE GUIDEZILLA II GUIDE CATHETER. BOTH THE GUIDEWIRE AND GUIDEZILLA II HAD TO BE PULLED OUT TO REMOVE THE DISLODGED STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16780175 ↗
• MalfunctionJan 13, 2023Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06JAN2023. IT WAS REPORTED THAT ANOTHER DEVICE COULDN'T ADVANCE THROUGH THE GUIDEZILLA. A 7F GUIDEZILLA II GUIDE EXTENSION CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, THERE WAS DIFFICULTY INSERTING ANOTHER DEVICE TO THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT COLLAR WAS PARTIALLY DETACHED AS IT WAS LIFTED FROM THE SHAFT MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158384 ↗