Phoenix Floppy Tip, Light Support Guidewire PG14300LFRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10845225002760), received between Sep 1, 2017 and Aug 14, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254047 ↗
• InjuryOct 29, 2025Material Separation; Material Separation

  HELLO NEW ROSS COMPLAINT HANDLING GROUP: WE HAVE RECEIVED A COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 7932023 WHERE THE DISTAL WIRE TIP BROKE. A SNARE WAS ATTEMPTED TO REMOVE THE BROKEN TIP BUT WAS UNSUCCESSFUL, THUS THE DISTAL TIP REMAINED IN THE LEFT FEMORAL ARTERY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4) DATE OF EVENT: 10/07/2025. PHILIPS REPORTABILITY AWARE DATE: 10/08/2025. COUNTRY: FRANCE (FRA). NATURE OF COMPLAINT: AT THE END OF THE PROCEDURE DURING THE RETRIEVAL OF THE PHOENIX CATHETER SYSTEM, THE GUIDE WIRE WAS BROKEN IN 2 PARTS. THE DISTAL PART REMAINED IN THE LEFT FEMORAL ARTERY. THE PRACTICIAN HAS TRIED TO CATCH IT WITH A SNARE BUT WITHOUT SUCCESS. DEVICE WILL NOT BE RETURNED. TYPE OF CASE: PERIPHERAL. ACCESS LOCATION: FEMORAL. VESSEL TORTUOSITY: SEVERE. PROCEDURE TYPE: THERAPEUTIC. WAS RESISTANCE ENCOUNTERED? NO. LESION CALCIFICATION: SEVERE. TYPE OF "TARGET" LESION: CALCIFIED. PERIPHERAL VESSEL: COMMON FEMORAL. VESSEL SEGMENT: PROX. ACCESS APPROACH: CONTRALATERAL. CHRONIC TOTAL OCCLUSION (CTO)? UNKNOWN. DID AN EMBOLIZATION OCCUR? YES. WAS THE SUPPORT CLIP US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416036 ↗
• MalfunctionJan 15, 2025Material Separation; Material Separation

  THE DEVICE WAS PREPARED AS PER IFU. AFTER INSERTING THE PHOENIX GUIDEWIRE PER IFU IN A DISTANCE TO THE TARGET VESSEL THE PHYSICIAN INSERTED THE PHOENIX CATHETER OVER THE WIRE WITHOUT RESISTANCE. SEVERAL PASSAGES WITH THE PHOENIX CATHETER WITHOUT ANY RESISTANCE OR NOISE CHANGE. AFTER PULLBACK OF THE DEVICE UNDER FLUOROSCOPY THE PHYSICIAN RECOGNIZED A SEPARATION OF THE PHOENIX WIRE. IT WAS NOT POSSIBLE, TO REMOVE THE SEPARATED PART OF THE WIRE. THE PHYSICIAN DECIDED TO LEAVE THE SEPARATED PART IN SITU. THE PHOENIX CATHETER COULD BE REMOVED WITHOUT ANY RESISTANCE. THE PATIENT IS IN A GOOD CONDITION AND DISCHARGED WITHOUT ANY SYMPTOMS. WHAT PART OF THE DEVICE SEPARATED? -THE END OF THE WIRE, ABOUT 15 CM. 1.ETHNICITY: NOT HISPANIC OR LATINO RACE: WHITE 2.WAS THERE ANY MALFUNCTION WITH THE PHOENIX CATHETER? NO 3.PLEASE PROVIDE THE PHOENIX LIGHT SUPPORT GUIDEWIRE LOT#. 6997007 4.DID EMBOLIZATION OCCUR? NO 5.MEDICAL HISTORY/ CO-MORBIDITIES: (SELECT ALL THE APPLY) CAD, HYPERTENSION, PAD, DIABETES 6.PRE-OP LABS/ TESTING: (SELECT ALL THE APPLY) CREATININE LEVEL 1.03 CT. 7.DID THE PHYSICIAN BELIEVE THE DEVICE CAUSED/CONTRIBUTED TO THE AE? NO 8.EMERGENT RESOURCES AVAILABLE AT THE FACILITY? COVE

  Patient problems: Foreign Body In Patient

  MAUDE report 21157521 ↗
• MalfunctionDec 20, 2024Fracture; Material Deformation; Fracture; Material Deformation

  DEVICE WAS FLUSHED AND PREPARED PER THE IFU, NO ABNORMALITIES, ENGINE TEST NORMAL. THE DEVICE WAS ADVANCED OVER THE PHOENIX WIRE TO THE STENOSIS IN THE ARTERIA POPLITEA. MULTIPLE ATHERECTOMY WITH GOOD RESULTS. THE DEVICE WAS ADVANCED INTO THE ANTERIOR TIBIAL ARTERY, MULTIPLE ATHERECTOMY. ACCORDING TO THE HCP, SUDDENLY A LOUD NOISE AND RESISTANCE OCCURED. HE STOPPED IMMEDIATELY, REMOVED THE DEVICE, FLUSHED THE ARTERY AND SAW THE WIRE RIPPED OPEN. HE WAS ABLE TO REMOVE THE WIRE FROM THE VESSEL WITHOUT RESISTANCE. THE PATIENT WAS TREATED WITH BALLOON DILATION. THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION RECEIVED ON 10/1/2024: MULTIPLE ATHERECTOMY IS STATED WHICH WAS MEANT BY PASSES. THE DEVICE WERE REMOVED SEPARATELY. THERE WAS NO DEVICE MALFUNCTION FOR THE PHOENIX CATHETER. PHOTOS RECEIVED ON 10/2/2024: COIL DAMAGE WAS OBSERVED BUT APPEARS INTACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20992954 ↗
• MalfunctionSep 12, 2024Fracture; Fracture

  COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 6996977 WHERE THE WIRE BROKE INTO THE INTRODUCER DURING THE LAST RUN BEFORE REMOVAL. THE DEVICE WILL BE RETURNED FOR EVALUATION. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4), DATE OF EVENT: 8/27/2024, PHILIPS REPORTABILITY AWARE DATE: 8/27/2024, COUNTRY: FRANCE (FRA). NATURE OF COMPLAINT: PHOENIX WAS BLOCKED AFTER THAT THE PHOENIX LIGHT SUPPORT GUIDE WIRE BROKE INTO THE INTRODUCER DURING THE LAST RUN BEFORE REMOVAL. DEVICE WILL BE RETURNED. TYPE OF CASE: PERIPHERAL ACCESS LOCATION: FEMORAL VESSEL TORTUOSITY: NONE PROCEDURE TYPE: PENDING WAS RESISTANCE ENCOUNTERED? NO LESION CALCIFICATION: PENDING TYPE OF "TARGET" LESION: CALCIFIED PERIPHERAL VESSEL: SFA VESSEL SEGMENT: PROX ACCESS APPROACH: CONTRALATERAL CHRONIC TOTAL OCCLUSION (CTO)? UNKNOWN WAS THE SUPPORT CLIP USED? (PHOENIX CATHETER): YES PHYSICIAN NAME: DR (B)(6). 1. PLEASE PROVIDE A PICTURE IF POSSIBLE? YES, SEE IN ATTACHMENT 2. WHERE ON THE DEVICE DID THE SEPARATION OCCUR? PROXIMAL PART 3. APPROXIMATELY WHAT IS THE LENGTH OF THE DEVICE THAT WAS SEPARATED IN THE PATIENT? 55 CM 4. COULD YOU PLEASE TELL US IF AN ANGIOGRAM WAS PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20198587 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  WE HAVE RECEIVED A COMPLAINT ON PHOENIX LIGHT SUPPORT GUIDEWIRE: (B)(6), LOT 7931939 WHERE THE OUTER COATING OF THE PHOENIX WIRE AND THE TIP BROKE OFF INSIDE THE PATIENT. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4). DATE OF EVENT: 3/20/2024. REPORTABILITY AWARE DATE: 3/22/2024. COUNTRY: GERMANY (DEU). NATURE OF COMPLAINT: AT THE START OF ROTATIONAL ATHERECTOMY WITH THE PHOENIX (B)(6)THE CATHETER HOOKED IN A SHORT SEGMENT, BUT AFTER THAT CONTINUED PROBLEM FREE TO PASS IN SEVERAL ANGULATIONS OR SECTORS. REMOVAL OF THE PHOENIX, ANGIOGRAPHY, HERE THE OUTER COATING OF THE PHOENIX WIRE IS VISIBLE INTRALUMINALLY OVER A LONGER DISTANCE. THE DISTAL TIP IS LOCATED IN A COLLATERAL OF THE ATP. THE PROXIMAL SECTION OF THE PROXIMAL AFS CAN BE FOUND SONOGRAPHICALLY. NO FLOW RELEVANCE. REMOVAL OF THE REMAINING WIRE WAS UNSUCCESSFUL. DCB PTA, IMPLANTATION OF A STENT. PATIENT WAS FINE AND DISCHARGED IN GOOD CONDITION. DEVICE WILL BE RETURNED. TYPE OF CASE: PERIPHERAL. ACCESS LOCATION: FEMORAL. VESSEL TORTUOSITY: NONE. PROCEDURE TYPE: THERAPEUTIC . WAS RESISTANCE ENCOUNTERED?: YES. LESION CALCIFICATION: SLIGHT. TYPE OF "TARGET" LESION: FIBROUS . PERIPHERAL VESS

  Patient problems: Foreign Body In Patient

  MAUDE report 19086357 ↗
• MalfunctionJan 11, 2024Fracture; Fracture

  PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 7931915 WHERE THE TIP BROKE OFF AND WAS RETAINED IN PATIENT. THE DEVICE WAS INFECTIOUS AND WILL NOT BE RETURNED FOR EVALUATION. COMPLAINT # (B)(4). DATE OF EVENT: 12/27/2023 PHILIPS REPORTABILITY AWARE DATE: 12/27/2023 COUNTRY: AUSTRALIA (AUS) NATURE OF COMPLAINT: THE PERONEAL ARTERY WAS LONGITUDINALLY OCCLUDED. IT WAS APPARENTLY PROBED INTRALUMINALLY USING A 0.018" COMMAND ST WIRE AND A NAVI CROSS SUPPORT CATHETER. SUBSEQUENTLY, THE PHOENIX WIRE (REF: PG14300LF LOT: 7931915) WAS INSERTED THROUGH THE SUPPORT CATHETER. THEN, THE PHOENIX 1.8 MM 130 CM 5F CATHETER WAS USED TO LONGITUDINALLY REOPEN THE PERONEAL ARTERY. AFTER ONLY ABOUT 2 MINUTES, THE PHOENIX ATHERECTOMY CATHETER BECAME OBSTRUCTED, CEASING TO DRIP LATERALLY FROM THE FLUSH PORT, AND AUDIBLE AND PALPABLE FRICTION DEVELOPED BETWEEN THE PHOENIX CATHETER AND PHOENIX WIRE. WHEN THE USER ATTEMPTED TO REMOVE THE PHOENIX CATHETER FROM THE PATIENT, THEY ENCOUNTERED SIGNIFICANT DIFFICULTIES DETACHING IT FROM THE PHOENIX WIRE. TO AVOID LOSING WIRE PASSAGE, THE USER RELEASED THE WIRE LOOP AT THE SUPPORT CLIP TO REMOVE THE PHOENIX WHILE IT WAS STILL IN MOTION. THIS WORKED SMOOTHLY. DURI

  Patient problems: Foreign Body In Patient

  MAUDE report 18490796 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT 7931915, THE COILS ON THE TIP OF THE GUIDEWIRE STARTED TO UNCOIL INSIDE THE PATIENT. THE WIRE WAS RECEIVED AND DECONTAMINATION WAS COMPLETED. COMPLAINT # (B)(4). DATE OF EVENT: 19 OCT 2023. COMPLAINT AWARE DATE: 19 OCT 2023. COUNTRY: UNITED STATES (USA). NATURE OF COMPLAINT: THE COILS. ON THE TIP OF THE GUIDEWIRE STARTED TO UNCOIL INSIDE THE PATIENT. THEY HAD TO REMOVE EVERYTHING. THEY WERE ABLE TO USE THE SAME CATHETER, BUT HAD TO USE ANOTHER GUIDEWIRE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 23 OCT 2023: THERE WAS NO COMPLETE WIRE SEPARATION. EVALUATION COMMENTS: THE DEVICE WAS ANALYZED AND NO SHARP PIECES WERE OBSERVED. THE GUIDEWIRE TIP IS INTACT, AND WHILE THE GUIDEWIRE COIL WAS UNCOILED, THE PIECES WERE MALLEABLE AND NO SHARP EDGES OR MISSING PIECES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210644 ↗
• MalfunctionAug 3, 2023Fracture; Fracture

  NATURE OF COMPLAINT: AFTER THE PROCEDURE WITH THE PHOENIX CATHETER, HE REMOVED THE PHOENIX WITHOUT COMPLICATIONS. HOWEVER, WHEN HE ATTEMPTED TO REMOVE THE WIRE FROM THE PATIENT, HE EXPERIENCED A SLIGHT RESISTANCE FOR A SHORT PERIOD OF TIME, AND THEN HE SAW OUTSIDE THE PATIENT THAT THE TIP OF THE WIRE WAS MISSING. THE TIP OF THE WIRE WAS LEFT IN A SIDE BRANCH OF THE ARTERY IN THE LOWER LEG.

  Patient problems: Foreign Body In Patient

  MAUDE report 17450424 ↗
• MalfunctionJul 14, 2023Fracture; Fracture

  WE HAVE RECEIVED A COMPLAINT FOR PHOENIX LIGHT SUPPORT GUIDEWIRE: PG14300LF, LOT (PENDING) WHERE THE TIP BROKE OFF AND WAS RETAINED IN PATIENT. IF YOU COULD SEND US A COPY OF THE INITIAL MDR BEFORE SUBMITTING FOR OUR REVIEW IT WOULD BE MUCH APPRECIATED. PLEASE LET US KNOW IF YOU HAVE ANY FURTHER QUESTIONS. THANK YOU. COMPLAINT # (B)(4). DATE OF EVENT: (B)(6) 2023. REPORTABILITY AWARE DATE: (B)(6) 2023. COUNTRY: UNITED STATES (USA). NATURE OF COMPLAINT: AS THEY WERE REMOVING THE DEVICE, THE CATHETER FELT TIGHT WHEN TRYING TO REMOVE, THERE WAS RESISTANCE. IN THE PROCESS OF REMOVING THE CATHETER, THE TIP OF THE GUIDEWIRE GOT SHEARED OFF AND WAS LEFT IN PATIENT. THE TIP WILL NOT BE REMOVED FROM PATIENT AT THIS POINT. THEY COMPLETED THE PROCEDURE WITH BALLOON. 1. WHERE WAS THE TIP OF THE WIRE LEFT IN PATIENT? BRANCH OF THE DP. 2. HOW MUCH OF THE WIRE WAS LEFT? THE TIP. 3. WHAT VESSEL AND HOW FAR DOWN THE VESSEL WAS THE TIP OF THE WIRE LEFT? DP ARTERY. 4. CONCOMITANT DEVICES, INCLUDE BRAND NAME AND SIZE. A. INTRODUCER SHEATH TERUMO 6FR 45CM.

  Patient problems: Foreign Body In Patient

  MAUDE report 17323316 ↗
• MalfunctionJun 2, 2023Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THE PHOENIX LIGHT SUPPORT GUIDEWIRE WAS USED IN A PERIPHERAL THERAPEUTIC PROCEDURE IN THE MID AND DISTAL RIGHT ANTERIOR TIBIAL ARTERY. A PHOENIX CATHETER WAS LOADED OVER THE GUIDEWIRE AND ATHERECTOMY STARTED FROM THE MID TO THE DISTAL PART OF THE LESION WITH NO ISSUES. AFTER THE ATHERECTOMY, THE CATHETER WAS TAKEN OUT TO INSERT A NON-PHILIPS BALLOON FOR POST DILATATION. AFTER DILATATION, THE PHYSICIAN WANTED TO USE THE NON-PHILIPS BALLOON FOR ANGIOGRAPHY; THEREFORE, REMOVED THE GUIDEWIRE WITH NO RESISTANCE ENCOUNTERED. HOWEVER, DURING X-RAY IT WAS OBSERVED THAT THE DISTAL PORTION OF THE GUIDEWIRE REMAINED IN THE PATIENT. VISUAL INSPECTION OF THE GUIDEWIRE CONFIRMED THE DISTAL PORTION WAS MISSING. THE 5 FR SHEATH WAS EXCHANGE TO A 6 FR SHEATH TO USE A SNARE, AND THE SEPARATED PORTION WAS SUCCESSFULLY REMOVED. NO EMBOLIZATION OCCURRED, THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048762 ↗
• MalfunctionMay 9, 2023Fracture; Fracture

  COMPLAINT # (B)(4). DATE OF EVENT: 4/21/2023. REPORTABILITY AWARE DATE: 4/21/2023. COUNTRY: UNITED STATES (USA). NATURE OF COMPLAINT: TIP OF THE WIRE BROKE OFF IN PATIENT'S FOOT. THEY WERE NOT ABLE TO REMOVE THE WIRE. THE WIRE WAS IN THE COLLATERAL AT A 90 DEGREE ANGLE. THE WIRE IS NOT SCHEDULED TO BE REMOVED FROM THE PATIENT'S FOOT. THE PROCEDURE WAS COMPLETED AS SCHEDULED. FACILITY NAME: (B)(6). FACILITY CONTACT NAME: (B)(6). FACILITY CONTACT #: (B)(6). FACILITY CONTACT EMAIL: (B)(6). ADDRESS: (B)(6). UNITED STATES PHYSICIAN NAME: DR. (B)(6). WAS PHYSICAL DAMAGE TO THE DEVICE OBSERVED?* YES. DID ANY PORTION OF THE DEVICE BECOME SEPARATED OR DETACH WITHIN THE PATIENT?* YES. DID AN EMBOLIZATION OCCUR?: NO. PROCEDURE TYPE: THERAPEUTIC. PERIPHERAL VESSEL: AT PERIPHERAL VESSEL SEGMENT: DISTAL. ACCESS APPROACH: CONTRALATERAL. WAS THE SUPPORT CLIP USED? (PHOENIX CATHETER) YES. WAS THE DEVICE FLUSHED PER THE IFU? YES. PRODUCT BEING RETURNED?* YES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Insufficient Information

  MAUDE report 16895085 ↗
• MalfunctionMay 7, 2022Fracture; Fracture

  NATURE OF COMPLAINT: AFTER PREPARATION ACCORDING TO THE INSTRUCTIONS FOR USE, INSERTION OF THE PHOENIX CATHETER OVER THE PHOENIX GUIDEWIRE UP TO 1 CM PROXIMAL TO THE LESION. FIXATION THE WIRE IN THE WIRE HOLDER, THE PHYSICIAN TURNED ON THE MOTOR, FLUID EXITED OUT OF THE DISPOSAL OUTLET. THE PHYSICIAN SLOWLY ADVANCE THE PHOENIX THROUGH THE CALCIFIED LEASION. AFTER HE HAD TREATED A DISTANCE OF ABOUT 10 CM, HE NOTICED A CHANGE IN THE ENGINE NOISE. THE PHOENIX COULD BE GUIDED. THEN THE MOTOR STOPPED WORKING, THE PHOENIX CATHETER COULD NOT BE MOVED. THE PHYSICIAN DESCRIBED A "STICKING" OF THE CATHETER. THE MOTOR STUTTERED AND STARTED AGAIN, AND THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM FROM THE VESSEL. AFTER REMOVING THE CATHETER, FLUOROSCOPIC CONTROL WITH THE PHOENIX GUIDEWIRE IN PLACE, THEN REMOVAL OF THE PHOENIX GUIDEWIRE. ADDITIONAL INFORMATION RECEIVED ON 02MAR2022: THE CATHETER WAS REMOVED BY ITSELF. THE ATHERECTOMY PROCEDURE WAS INCOMPLETE BUT EFFECTIVE ENOUGH FOR THE PATIENT VESSEL STATUS AS THE PHYSICIAN REPORTED. BALLOON DILATATION AFTER REMOVAL OF THE ATHERECTOMY DEVICE, STENT IMPLANTATION AFTER BALLOON DILATATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315649 ↗
• MalfunctionApr 20, 2022Fracture; Fracture

  NATURE OF COMPLAINT: THE ATHERECTOMY DEVICE AS WELL AS THE GUIDEWIRE WAS PREPARED AS PER INDICATIONS IN THE IFU. THE CATHETER WAS USED SUCCESSFULLY FOR APPROXIMATELY 5-6 BACK AND FORTH RUNS. AS THE PHYSICIAN TRIED TO REMOVE THE CATHETER OVER THE GUIDEWIRE, A BIG RESISTANCE WAS OBSERVED. THE PHYSICIAN BELIEVED THE GUIDEWIRE WAS STUCK IN THE CATHETER. THE USER TURNED THE MOTOR BACK ON TO EASE UP TENSION BETWEEN THE CATHETER AND THE GUIDEWIRE (UNTIL THE SHEATH). FIRST THE CATHETER AND THEN THE GUIDEWIRE WERE REMOVED. THE GUIDEWIRE HAD THREAD/FIBERSHAPED PART IN THE TIP. IT IS UNKNOWN WHEN EXACTLY THIS OCCURED DURING USE. THE PATIENT IS DOING WELL AND WAS DISCHARGED. ADDITIONAL INFORMATION RECEIVED 15-MAR-2022: BASED ON NEW INFORMATION THE LOCATION OF THE BREAK IS MALLEABLE AND THERE WAS NO COMPLETE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164041 ↗
• MalfunctionNov 30, 2021Fracture; Fracture

  NATURE OF COMPLAINT: THE INTERVENTION WAS IN THE LOWER LIMB, THE ARTERY WAS VERY HARD CALCIFIED. THE LESION WAS PASSED WITH A REGULAR GUIDE WIRE, AFTERWARDS WITH DER THE PHOENIX GUIDEWIRE, AS THERE WAS NO CHANCE TO CROSS THE LESION WITH A PTA BALLOON (2.0). THE PHOENIX - GUIDEWIRE WAS SHREDDED BY THE PHOENIX 1.5 WHILE PUTTING MUCH EFFORT INTO THE HEAVY CALCIFIED LESION. THE SHREDDED GUIDEWIRE SENT WAS FROM THE COMPLAINT ISSUE. THE SHREDDED GUIDEWIRE AND THE PHOENIX 1.5 WERE NOT REMOVABLE SEPARATELY, SO THEY WERE REMOVED TOGETHER. WITH MUCH EFFORT THE SEPARATED GUIDEWIRE WAS REMOVED FROM THE DISTAL PART OF PHOENIX 1.5 (OUTSIDE OF THE BODY). AS PHOENIX 1.5 SOUND WELL AFTER REMOVEMENT, IT WAS USED AGAIN. WITH A 2ND GW (DIFFERENT BOX) THE TARGET LESION WAS TREATED SUCCESSFULLY, AS IT WAS LUCKILY POSSIBLE TO PASS THE LESION AGAIN. THERE WERE NO RADIOPAQUE WIRE PARTS VISIBLE. FACILITY NAME: KANTONSSPITAL BADEN ADDITIONAL INFORMATION RECEIVED 11/18/2021: 2. WAS THERE ANY PHYSICAL DAMAGE OBSERVED ON THE DEVICE? YES A. IF THE DEVICE WAS DAMAGED: B. PLEASE DESCRIBE: SHREDDED 3. DID ANY PORTION OF THE DEVICE SEPARATE WITHIN THE PATIENT? YES 4. WAS THERE ANY PATIENT INJURY? NO 5. WAS THERE ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891340 ↗
• MalfunctionApr 12, 2021Fracture; Fracture

  WE HAD A CASE OF WIRE FAILURE WHEN USING THE 1.8 PHOENIX. WE USED THE PHOENIX FLOPPY WIRE. THE WIRE WAS RETRIEVED THE PATIENT IS FINE. WIRE AND CATHETER WERE IN THE LEFT PT. AS YOU CAN SEE FROM THE IMAGES THE CATHETER NEVER APPROACHED THE TIP OF THE WIRE. THERE WAS RESISTANCE WHEN REMOVING THE PHOENIX BUT WAS REMOVED SUCCESSFULLY. AN .014 SLEEK BALLOON WAS ADVANCED TO THE SAME AREA AND WAS NOT ABLE TO CROSS THE WIRE AREA IN QUESTION. THE WIRE AND BALLOON WERE THEN REMOVED AS AN ASSEMBLY AND THE WIRE REMAINED IN THE BALLOON THAT HAS ALSO BEEN PROVIDED. THERE WIRE BRAKE WAS FUNCTIONAL AND THERE WAS NO ISSUES AT PREP. THE WIRE WAS NEW AND HAD BEEN EXCHANGED FOR THE ORIGINAL PT CHOICE WIRE THAT HAD BEEN USED TO CANNULATE THE VESSEL. AT SOME POINT THERE HAD BEEN FRICTION THAT HAD CREATED THAT HAD WORN AN AREA OF THE DISTAL END OF THE WIRE. THE PHOENIX CATHETER COMPLAINT (B)(4) WAS OPENED CONCOMITANT TO THIS COMPLAINT (B)(4) . (PHOENIX 1.8MM X 130 CM CATHETER, P18130K LOT NUMBER 11052002-039. PATIENT WAS DISCHARGED AS PLANNED; AMBULATORY AND IN GOOD CONDITION. DATE OF OCCURRENCE: (B)(6) 2020 DATE OF AWARENESS: (B)(6) 2021 (THAT GUIDEWIRE MAY HAVE CAUSED OR CONTRIBUTED TO DISSECTION) . AD

  Patient problems: Vascular Dissection

  MAUDE report 11653531 ↗
• InjuryJan 26, 2021Fracture; Fracture

  WE HAVE RECEIVED A COMPLAINT FROM EUROPE WITH THE PHOENIX GUIDEWIRE PG14300LF WHERE THE WIRE TIP WAS REPORTED FRACTURED ; AND THEREFORE THIS IS A REPORTABLE EVENT BOTH IN THE US AND IN EUROPE (VOLCANO HAS THE RESPONSIBILITY FOR EU REPORTING). THE TIP FRAGMENT WAS RETRIEVED WITH A SNARE SO NOTHING WAS LEFT IN THE PATIENT AND THE PATIENT IS FINE. AT THIS TIME, BOTH THE WIRE DEVICE NOR THE PHOENIX CATHETER WILL NOT BE RETURNED TO PHILIPS. WE ARE IN THE PROCESS OF TRYING TO GET MORE INFORMATION ON THE PRODUCT EXPERIENCE BUT DUE TO THE WIRE FRACTURE, WE WANTED TO GET THIS INFORMATION TO YOU AS QUICKLY AS POSSIBLE TO MEET REPORTING DEADLINES. 2021 PER COORDINATOR: ANTEGRADE APPROACH; WITH A 7 FR SHEATH; CALCIFIED LESION FROM THE PROXIMAL SFA UP TO THE P2 SEGMENT. AFTER PASSAGE WITH A 0.018 ADVANTAGE OF THE COMPLETE VESSEL THE PHOENIX GUIDEWIRE WAS CHANGED BEFORE THE TREATMENT USING A MICROCATHETER. CUSTOMER SAID THAT HE PLACED THE GUIDEWIRE INTO THE TRACTUS THAT WAS ABOUT 10 CM FROM THE KNEE JOINT. HE WANTS TO AVOID A MORE DISTAL GUIDEWIRE PASSAGE BECAUSE THE ATA WAS ONLY SMALL AND WORKED MORE VIA COLLATERALS AND THE PERONEA AS THE LEADING BTK VESSEL WAS ALSO A BIT SMALL. HE WANTED TO AV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229483 ↗
• MalfunctionDec 11, 2020Fracture; Fracture

  THE TIP OF THE FLOPPY GUIDEWIRE WAS BROKEN INSIDE THE BODY. THE TIP WAS RETRIEVED ONE DAY AFTER THE CASE ON 11/13/2020. THE PATIENT IS OKAY. THE PATIENT HAD SIGNIFICANT SPASM AND IT WAS THROUGH THIS SPASM WAS CAUSED, OR CONTRIBUTED TO THE WIRE MALFUNCTION. THERE WAS SOME GUIDEWIRE RESISTANCE. THE MALFUNCTION OCCURRED AS THE PHOENIX CATHETER WAS BEING REMOVED. ASSOCIATED WITH PHOENIX CATHETER COMPLAINT #: (B)(4). (PHOENIX 1.8MM X 130CM; CATHETER (B)(4); LOT NUMBER: 10281908-007). PATIENT INJURY, ADDITIONAL INTERVENTION, AND HOSPITALIZATION REQUIRED. PATIENT WAS DISCHARGED. DATE OF OCCURRENCE: (B)(6) 2020; DATE OF AWARENESS: NOVEMBER 17 2020; ADDITIONAL INFORMATION RECEIVED: 11/23/2020; ADDITIONAL INFORMATION IS PROVIDED BELOW, AND ATTACHED. WHICH GUIDEWIRE WAS USED? PHOENIX FLOPPY GUIDE WIRE; REF.#: (B)(4); LOT #: 10935428. WERE ALL PORTIONS OF THE DEVICE ACCOUNTED FOR? YES. THE REMAINDER OF THE WIRE WAS REMOVED SUCCESSFUL THE NEXT DAY THROUGH AN OPEN PROCEDURE. IS THERE AN ALLEGATION THAT OUR DEVICE CAUSED, OR CONTRIBUTED TO THE MALFUNCTION? THERE WAS WIRE STICK. HOWEVER, THE PATIENT HAD SIGNIFICANT SPASM, AND IT WAS THROUGH THIS SPASM WAS CAUSAL, OR CONTRIBUTED TO THE WIRE MALFUNC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991052 ↗
• MalfunctionNov 2, 2020Fracture; Fracture

  WHEN CHANGING THE WIRE FROM A 14 VOLCANO TO AN 18 WIRE OVERLYING BALLOON CATHETER, MEDTRONIC IN.PACT PACIFIC PACLITAXEL ELUTING SIZE 5/120/130, TEAR OFF THE FLEXIBLE NON-COATED TIP OF THE 014 WIRE WITH SUBSEQUENT OUTFLOW INTO 2 DITAL LOWER LEG ARTERIES WITH ONE (ATA) BEING LAID DISTALLY. FURTHER INFORMATION IS ALSO AVAILABLE FROM (B)(6). DR. (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 10775414 ↗
• MalfunctionSep 23, 2020Material Integrity Problem; Material Integrity Problem

  THE PHOENIX WIRE WAS LOCK TO THE PHOENIX CATHETER AT THE END OF FINAL RUN. THE WIRE AND THE CATHETER WAS REMOVED WITH NO ISSUES. THE REST OF THE PROCEDURE WAS COMPLETED WITH BALLOON. ASSOCIATED WITH PHOENIX CATHETER (PHOENIX CATHETER SYSTEM, 1.8MM) COMPLAINT (B)(4). NO PATIENT INJURY. DATE OF OCCURRENCE: (B)(6) 2020. DATE OF AWARENESS: 8/27/2020. AS PER COMPLAINT FILE - DAN LANG RESPONDED: -PLEASE CONFIRM IF THERE WAS A PHOENIX WIRE FAILURE AS WELL? THE WAY I WAS TOLD, IT WAS A WIRE LOCK DUE TO COATING FAILURE. -PLEASE EXPLAIN HOW DID THE DEVICE FAIL? THE WAY I WAS TOLD, IT WAS A WIRE LOCK DUE TO COATING FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10572383 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FOR A THERAPEUTIC PERIPHERAL PROCEDURE THE USER PLUGGED IN ATHERECTOMY CATHETER DEVICE, FLUSHED, MADE ONE PASS THAT WAS FINE, AND CAME BACK TO MAKE THE SECOND PASS. THE ATHERECTOMY DEVICE ALMOST STOPPED. THE PHYSICIAN PULLED BACK SLIGHTLY AND GOT IT TO WORK. WHEN THEY TRIED TO ADVANCE, IT WAS LIKE THERE WAS A BLOCKAGE. THEY STOPPED, PULLED THE ATHERECTOMY DEVICE AND DID ANGIOGRAM AND SAW THE THERE WAS A SUBSTANCE ON THE WIRE. THEY THEN TRIED TO ADVANCE A BALLOON DOWN THE WIRE AND IT WOULD NOT GO. THEY TRIED ADVANCING IT [THE CATHETER] AGAIN BUT WAS UNABLE. WHEN THEY PULLED THE WIRE THEY SAW SOMETHING ON THE WIRE THAT HAD BEEN PREVENTING THE PASS. PATIENT EXPERIENCED AN EVENT OF PERFORATED ARTERY AT ANTERIOR TIBIAL. PATIENT WAS RELEASED AS EXPECTED IN STABLE CONDITION. ON (B)(6) 2017 THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL POST-PROCEDURE. VESSEL: 99% OCCLUSION, LOCATED ANTERIOR TIBIAL, MODERATELY CALCIFIED. THIS EVENT IS BEING REPORTED BECAUSE THERE WAS A PATIENT EVENT DURING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 6840276 ↗