Phoenix Floppy Tip, Extra Support Guidewire PG14300XFRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10845225002746), received between May 30, 2020 and Jul 27, 2021 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Fracture; Fracture

  THE DISTAL PART OF THE WIRE BROKE OFF INSIDE THE BODY. THEY REMOVED THE PIECE OF THE WIRE FROM INSIDE THE BODY THROUGH SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230871 ↗
• MalfunctionMay 24, 2021Fracture; Fracture

  WIRE WAS BACKLOADED INTO THE PIONEER PLUS DEVICE. UPON REMOVAL OF THE PIONEER, THE WIRE WAS REMOVED FROM THE DEVICE. ONCE THE WIRE WAS REMOVED, WE NOTICED THE WIRE HAD UNRAVELED TO THE THICKNESS OF A HAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873694 ↗
• InjuryMay 13, 2021Fracture; Fracture

  THE DEVICE WAS ADVANCED TO THE LESION AND WHEN A SECOND PASS WAS REQUIRED, THE DEVICE WAS REMOVED WITHOUT INCIDENCE. UPON REMOVAL AND CORRELATED WITH X-RAY, A SMALL PORTION OF THE PHOENIX LIGHT SUPPORT WIRE WAS NOTICED TO HAVE BROKEN OFF AND WAS IN THE LOWER LEG. THE BROKEN SEGMENT WAS APPROXIMATELY 10 IN LONG AND WAS VERY NOTICEABLE. THE SURGEON ADVANCED ANOTHER WIRE DOWN TO THE AREA AND USED A GOOSENECK SNARE TO RETRIEVE THE SEGMENT OF THE PHOENIX WIRE. X-RAYS WERE USED TO CONFIRM THAT ALL PORTIONS OF THE WIRE WAS REMOVED. THE PATIENT'S OUTCOME WAS GOOD. ADDITIONAL INFORMATION: THE PREP OF BOTH THE PHOENIX WIRE AND PHOENIX CATHETER WERE NORMAL. NO DAMAGE WAS OBSERVED PRIOR TO USE. THE DEVICES HAD A LITTLE TROUBLE AT THE LESION BUT WERE REMOVED WITHOUT INCIDENT. THERE WERE NO OTHER ISSUES WITH THE DEVICES UNTIL REVIEWED UNDER X-RAY. THEN IT WAS NOTICED A PORTION OF THE DISTAL TIP WAS LEFT IN THE PATIENT. NO UNUSUAL FORCE WAS USED ON THE DEVICES AND THERE WAS NO DIFFICULTY ADVANCING THE DEVICES. A GOOSENECK SNARE WAS USED TO REMOVE THE DEVICE. NO OTHER DEVICES WERE USED AT THE SAME TIME AS THE PHOENIX DEVICES. THE DEVICES WERE SHIPPED. THE PATIENT WAS DISCHARGED AND IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822981 ↗
• MalfunctionMay 13, 2021Fracture; Fracture

  THIS WIRE "UNRAVELED" AFTER THE PHOENIX WAS USED OVER IT. ADDITIONAL INFORMATION: 1. DID THE PHOENIX CATHETER CONTRIBUTE TO THE DAMAGED PHOENIX GUIDEWIRE? YES. 2. WAS RESISTANCE ENCOUNTERED? TOWARD THE END OF THE CASE. 3. WAS THE PHOENIX WIRE REMOVED WITH THE CATHETER? YES. 4. APPROXIMATELY HOW FAR WAS THE CATHETER OVER THE WIRE FROM THE WIRE'S DISTAL TIP? 4 CM LEFT TO TIP. 5. WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? NO. 6. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? NO. 7. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? YES. 8. WHAT ACTIONS WERE PERFORMED ON THE GUIDEWIRE TO PREPARE THE GUIDEWIRE FOR USE? WIPED. 9. WERE ANY PROBLEMS NOTED DURING PREPARATION? NO. 10. WAS THE GUIDEWIRE PREPPED PROPERLY ACCORDING TO THE IFU? YES. 11. WAS THERE DIFFICULTY ADVANCING THE DEVICES OVER THE GUIDE WIRE? NO . 12. WHAT WAS THE INTENDED PROCEDURE? ATHERECTOMY OF LESION. 13. WAS THERE ANY DIFFICULTY ADVANCING THE GUIDEWIRE TOWARDS THE TARGET LESION? SLIGHT. 14. WAS THE DEVICE REMOVED EASILY AND INTACT FROM THE PATIENT? DEVICE WAS REMOVED WITH WIRE . NO PT HARM. 15. WAS UNUSUAL FORCE EVER REQUIRED WHEN USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822901 ↗
• InjuryApr 28, 2021Fracture; Fracture

  PHOENIX WAS PREPARED IN A NORMAL WAY. HANDLE WAS CONNECTED AND FLUSHED, TORQUER WAS USED DURING THE ATHERECTOMY. THE TREATMENT WASAN ATHERECTOMY WITH THE PHOENIX DEVICE OF TWO LESSIONS IN THE RIGHT SFA AND POPLITEA. DZURING THE SECOND PASSAGE OF THE DISTAL LESSION THE HANDLE STOPPED TWICE. THE PHYSICIAN RECONNECTED THE HANDLE AND WE COULD PROCEED THE 2ND PASSAGE OF THE DISTAL POPLITEAL LESSION. THE CONTROL ANGIOGRAPHY SHOWED THAN A DISSECTION IN THE POPLITEAL SEGMENT AND A LEAK OF CONTRAST MEDIA.THE PHYSICIAN DECIDED TO MAKE A PROLONGED DILATATION ( BOSTON SCIENTIFIC BALLOON 5X100) OVER 10 MINUTES WITH AN OUTSIDE PRESSURE WITH A BLOOD PRESSURE CUFF. FIRST CONTROL SHOWED A GOOD RESULT WITH NO LEAKS OF CONTRAST MEDIA ANYMORE. HE TREATED THE PROXIMAL LESSION AS WELL WITH AN ANGIOPLASTY BALLOON 5/100. AFTER ALL HE CHECKED THE WHOLE LEG FROM PROXIMAL UP TO THE FOOT. IN CONSULTATION WITH THE VASCULAR SURGEON THE DECISION WAS TO KEEP IT WITHOUT STENTING. PATIENT WAS FINE ALL THE TIME, NO PAIN, NO ISSUES.

  Patient problems: Vascular Dissection

  MAUDE report 11741822 ↗
• InjuryApr 28, 2021Fracture; Fracture

  WE HAVE RECEIVED A COMPLAINT ON THE EXTRA SUPPORT GUIDEWIRE PG14300XF, LOT 11012470 WHERE THE WIRE TIP FRACTURED DURING USE WITH THE PHOENIX CATHETER. THE WIRE USED WITH PHOENIX ATHERECTOMY DEVICE. WHEN WIRE WAS WITHDRAWN , IT WAS SHEARED. THE DISTAL TIP REMAINED IN THE PATIENT. TIP WAS RETRIEVED WITH A SNARE. NO APPARENT INJURY TO PATIENT. ADDITIONAL INFORMATION FROM QUESTIONS SUBMITTED TO SALES REPRESENTATIVE. 1)PRODUCT IS RETURNING. WAS IT EXPOSED TO INFECTIOUS PATHOGENS? NO . 2) WAS PROCEDURE COMPLETED WITH SUSPECT DEVICE? NO. THE WIRE THAT WAS BROKEN WAS SNARED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT WIRE. 3) PHYSICIAN NAME? DR. (B)(6). 4)TYPE OF CASE: CORONARY OR PERIPHERAL? PERIPHERAL. 5)ACCESS LOCATION: BRACHIAL, RADIAL OR FEMORAL? FEMORAL . 6) VESSEL TORTUOSITY? NO . 7) WAS PHYSICAL DAMAGE TO THE DEVICE OBSERVED? YES. 8)DID ANY PORTION OF THE DEVICE BECOME SEPARATED OR DETACH WITHIN THE PATIENT? YES. 9)DID AN EMBOLIZATION OCCUR? NO- THE BROKEN PIECE OF THE WIRE WAS SNARED. 10)STATUS DECLINE, EVIDENCE OF INJURY OR ANY REQUIRED INTERVENTION TO PREVENT INJURY? NO. LINGERING INJURY TO THE PATIENT THE BROKEN PIECE WAS SNARED SUCCESSFULLY . 11)WAS RESISTANCE ENCOUNT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741814 ↗
• MalfunctionNov 24, 2020Fracture; Fracture

  THE TIP OF THE WIRE BROKE INSIDE THE BODY DURING REMOVAL, THERE WAS RESISTANCE FELT BUT THE DEVICE WAS NOT STUCK. THEY SNARED THE BROKEN PIECE OUT. THE PATIENT IS FINE AND THERE WAS NO HARM. THERE WAS NO PHYSICAL DAMAGE OBSERVED DURING PREPARATION. NO PATIENT INJURY ; PATIENT WAS DISCHARGED. ADDITIONAL PATIENT INFORMATION IS BELOW 1. WHAT OTHER DEVICES WERE BEING USED AT THE SAME TIME AS THIS DEVICE? (INTRODUCER, GUIDE CATHETER, GUIDE WIRE, STENT, OTHER?) PLEASE PROVIDE THE MANUFACTURER, DEVICE NAME, AND DEVICE DESCRIPTION FOR EACH OF THESE DEVICES.- 2.2 PHOENIX CATHETER. 2. IS THE DEVICE RETURNING? IF YES PLEASE CONFIRM IT WAS NOT EXPOSED TO INFECTIOUS ENVIRONMENT? RETURNING YES, NOT INFECTIOUS. 3. WAS PROCEDURE COMPLETED WITH SUSPECT DEVICE? YES. 4. HOW WAS THE PROCEDURE COMPLETED? THE WIRE PIECE WAS SNARED OUT AT THE END OF THE PROCEDURE. INTERVENTION PRIOR WAS COMPLETE. 5. WHAT WAS THE OUTCOME OF THE PROCEDURE? SUCCESSFUL. 6. WAS ANY ADDITIONAL UNSCHEDULED INTERVENTION REQUIRED TO REMOVE THE DEVICE? NO. A. IF YES, DESCRIBE THE INTERVENTION:. 7. WAS ANY ADDITIONAL UNSCHEDULED MEDICAL OR SURGICAL INTERVENTION REQUIRED DUE TO DEVICE MALFUNCTION? THEY HAD TO SNARE OUT THE WIRE PIEC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10892081 ↗
• MalfunctionMay 30, 2020Material Deformation; Material Deformation

  135273 PHOENIX EXTRA SUPPORT GUIDEWIRE (EA) 5/7: PER COORD: UPON REMOVAL OF THE CATHETER, THE CATHETER KEPT GETTING STUCK ON THE DISTAL POINT OF ACCESS OF THE SHEATH. IT WAS VERY DIFFICULT TO REMOVE BUT WHEN THEY FINALLY REMOVED THE CATHETER, THEY NOTICED IT HAD DEVELOPED A TIGHT KINK IN THE LOWER AREA. 5/11: AN EMAIL RESPONSE WAS RECEIVED BY THE SOURCE WITH THE FOLLOWING INFORMATION: WE USED A 2.2 PHOENIX DEFLECTED CATHETER. PREPPED THE CATHETER BASED ON INSTRUCTIONS IN IFU, SECURED WIRE APPROPRIATELY, TURNED DEVICE ON PROXIMAL TO LESION AND WAITED FOR BLOOD RETURN FROM SIDE PORT. ONCE WE RECEIVED BLOOD RETURN, WE ADVANCED THE CATHETER THROUGH LESION, DOING 2 PASSES. PROBABLY RAN ABOUT 30 SECONDS. AFTER TREATMENT WAS COMPLETED, WE TURNED DEVICE OFF AND THE DEVICE WAS GENTLY REMOVED FROM THE BODY. WHEN THE DEVICE CAME OUT, THERE WAS A STRING OF METAL ABOUT THE SIZE OF HAIR THAT CAME OUT OF THE SHEATH. ONCE THAT, A CROSSING CATHETER WAS PLACED OVER THE WIRE TO ENCAPSULATE ANY POSSIBLE LOOSE PIECES AND EVERYTHING WAS REMOVED. THE WIRE, INCLUDING THE TIP WAS, REMOVED IN-TACT. AN ANGIOGRAM WAS PERFORMED AFTER REMOVAL TO VERIFY 3 VESSEL RUNOFF AND A CAREFUL EXAMINATION WAS PERFORMED TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10103802 ↗