ZIPwire™ M0066802220Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00816349011825), received between Aug 10, 2022 and Sep 17, 2026 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (40 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Contamination

  Event Description: The nurse took the package with the product they were going to use. Before she opened the package, she noticed a piece of hair inside the package and they took another of the same device for using at the surgery. What troubleshooting steps took place? What troubleshooting steps, if any, resolved the issue?: They used another of the same device. What is the next course of action?: The device will be returned. Patient present at time of event?: Yes Device Acquired from a Distributor?: NoAdditional information from the Distributor:Device 1: UPN M0066802220, Model Number null, Lot or Serial Number JZ10486908If failure mode is 'Other,' details: There was a piece of hair in the packageWas issue present upon opening package?: NoPhoto or video of issue: Yes - I want to upload filesTime of Event: Preparation/Prior to Procedure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806143 ↗
• MalfunctionMay 22, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: WHEN THE PACKAGE WAS OPENED IN PREPARATION FOR PROCEDURE, IT WAS FOUND THAT THE GUIDEWIRE COATING FELL OFF AND IT COULD NOT BE USED. THE DEVICE IS EXPECTED TO BE RETURNED AROUND MAY. 25TH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES. IMAGE PROVIDED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25258604 ↗
• MalfunctionMay 13, 2026Contamination

  EVENT DESCRIPTION: IT WAS REPORTED THAT: BEFORE THE DEVICE WAS UNPACKED, IT WAS FOUND HAIR INSIDE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND MAY. 14TH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE . WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION PATIENT OUTCOME FROM THE EVENT: NONE PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES PHOTO PROVIDED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164295 ↗
• MalfunctionApr 27, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: DURING PREPARATION, WHEN UNPACKING THE PACKAGE, IT WAS FOUND THAT THE URETERAL STENT WAS FRACTURED. THE DEVICE IS EXPECTED TO BE RETURNED AROUND APR 17TH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. EVENT RESOLVED? YES. DISTRIBUTOR REPORT INDICATED A PHOTO WAS INCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008370 ↗
• MalfunctionMar 2, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE HYDROPHILIC COATING WAS FOUND TO BE UNEVEN IN PREPARATION FOR PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND FEB 25TH. EVENT RESOLVED? YES WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: NONE. ADDITIONAL INFORMATION PROVIDED 10 FEBRUARY 2026: 1. ARE THERE ANY IMAGES AVAILABLE?---SEE THE ATTACHMENT FOR DETAILS 2. WAS THERE VISIBLE DAMAGE TO THE DEVICE AND/OR ITS PACKAGING PRIOR TO USE?---NO 3. PLEASE EXPLAIN WHAT IS MEANT BY "UNEVEN."---THE GUIDEWIRE WAS NOT SMOOTH. A. IS THEIR DAMAGE TO THE BLACK POLYMER JACKET? ---NO B. IS THE METALLIC CORE WIRE EXPOSED? ---NO 4. WERE THERE ISSUES REMOVING THE ZIPWIRE FROM THE PROTECTIVE HOOP?---ENCOUNTERED RESISTANCE AND THE EXTRACTION PROCESS WAS NOT SMOOTH. 5. DID THE END-USER HYDRATE ZIPWIRE PRIOR TO REMOVAL FROM THE PROTECTIVE HOOP?---YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481865 ↗
• MalfunctionFeb 27, 2026Material Deformation

  PER CNF: AFTER UNPACKING, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS BENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE EVENT RESOLVED? YES ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION PATIENT OUTCOME FROM THE EVENT: NONE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. ADDITIONAL INFORMATION PROVIDED 16 JANUARY 2026: · IS THERE AN IMAGE OF THE REPORTED DEFECT? YES. DID THE END-USER HYDRATE THE WIRE PRIOR TO ATTEMPTING TO REMOVE IT FROM THE DISPENSER HOOP PER THE IFU? THE DEVICE WAS FOUND TO HAVE THE ISSUE BEFORE IT WAS UNPACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474381 ↗
• MalfunctionFeb 24, 2026Material Split, Cut or Torn

  EVENT DESCRIPTION: WHEN THE PHYSICIAN OPENED THE PACKAGE, THE GUIDE WIRE INSIDE WAS FRACTURED BY PULLING, AND THEN THE TIP FELL OFF. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. EVENT RESOLVED: YES. ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: OBSERVATION. PATIENT OUTCOME FROM THE EVENT: NONE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429163 ↗
• MalfunctionFeb 6, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE HYDROPHILIC COATING WAS FOUND TO BE CRACKED IN PREPARATION FOR PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHEN WAS THE PROBLEM NOTICED: PREPARATION. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. EVENT RESOLVED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280554 ↗
• MalfunctionFeb 5, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: THE CUSTOMER WAS USING OUR ZIPWIRE STIFF FOR THE SEMI RIGID URS PROCEDURE WHERE THE PATIENT HAD A URETERAL STONE. WHEN THE SURGEON INSPECTED THE GUIDEWIRE DURING THE PROCEDURE, HE NOTICED THAT THE COATING WAS SCRAPED OFF FROM THE GUIDEWIRE. THEY THEN REMOVED THE GUIDEWIRE AND REPLACED IT WITH ANOTHER OF THE SAME. THE PROCEDURE COULD BE COMPLETED WITHOUT ANY OTHER ISSUES. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? THEY USED ANOTHER OF THE SAME DEVICE. WHAT IS THE NEXT COURSE OF ACTION? THE DEVICE WILL BE RETURNED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. PATIENT OUTCOME: FULLY RECOVERED. DEVICE ACQUIRED FROM A DISTRIBUTOR? NO. WAS ISSUE PRESENT UPON OPENING PACKAGE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268545 ↗
• MalfunctionFeb 3, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE HYDROPHILIC COATING WAS FOUND TO BE DAMAGED IN PREPARATION FOR PROCEDURE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE PATIENT CONDITION FOLLOWING PROCEDURE - STABLE. WHEN WAS THE PROBLEM NOTICED: PREPARATION. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. EVENT RESOLVED? - YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248430 ↗
• MalfunctionFeb 2, 2026No Apparent Adverse Event; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF: AFTER UNPACKING, IT WAS FOUND THAT THE GUIDEWIRE COATING PEELED OFF. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. EVENT RESOLVED? YES. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. IMAGE RECEIVED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239992 ↗
• MalfunctionFeb 2, 2026No Apparent Adverse Event; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: IT WAS FOUND THAT THE GUIDEWIRE COATING FELL OFF UPON UNPACKING. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6) 2026. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT EVENT RESOLVED? YES. IMAGE RECEIVED (B)(6) 2026. ADDITIONAL INFORMATION PROVIDED 12 FEBRUARY 2026: 1. DID THE END-USER HYDRATE THE ZIPWIRE PRIOR TO REMOVING IT FROM THE PROTECTIVE HOOP AS INSTRUCTED IN THE IFU? YES. 2. IS THIS AN EXPERIENCED ZIPWIRE END-USER? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24237803 ↗
• MalfunctionFeb 2, 2026Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: AT THE END OF THE PROCEDURE, IT WAS FOUND THAT THE HYDROPHILIC GUIDEWIRE COATING HAD FALLEN OFF AND HAD NOT FALLEN INTO THE PATIENT'S BODY. THE DEVICE IS EXPECTED TO BE RETURNED AROUND (B)(6). THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. EVENT RESOLVED? YES. IMAGES RECEIVED (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234499 ↗
• MalfunctionDec 26, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT, THE HYDROPHILIC COATING WAS NOT ENOUGH, AND THE USING WAS NOT SMOOTH. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. EVENT RESOLVED? YES. IMAGE PROVIDED 19 NOVEMBER 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898326 ↗
• MalfunctionDec 3, 2025Device Damaged by Another Device; Material Deformation; Material Split, Cut or Torn; Device Damaged by Another Device; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE GUIDEWIRE ENTERED INSIDE THE PATIENT, IT WAS NORMAL, BUT IT GOT STUCK WHEN BEING WITHDRAWN FROM THE PATIENT. DURING THE PROCESS OF THE PHYSICIAN PULLING IT OUT WITH A SLIGHT FORCE, 5-6CM OF THE SKIN WAS DETACHED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: PROCEDURE CLOSURE WHERE DID THE PROBLEM OCCUR?INSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES. IMAGES RECEIVED 18 NOVEMBER 2025. ADDITIONAL INFORMATION PROVIDED 1 DECEMBER 2025: 1. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. - BSC ZERO TIP NITINOL STONE RETRIEVAL BASKET: M0063901050, 1.9F - BSC NAVIGATOR HD URETERAL ACCESS SHEATH SET: M0062502220, 1/13F*36CM. 2. WAS THE ZIPWIRE ADVANCED/WITHDRAWN THROUGH A METAL CANNULA OR NEEDLE? THROUGH A METAL CANNULA A. DID ANY PART OF THE GUIDEWIRE DETACH INSIDE THE PATIENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709273 ↗
• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION AND IMAGE PROVIDED (B)(6) 2025: 1. IS THERE AN IMAGE OF THE REPORTED DEFECT?--YES. 2. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.: BASKET MODEL: M0063901050 SPECIFICATION: 1.9F BRAND: BSC 2. URETERAL SHEATH MODEL: M0062502220 SPECIFICATION: 11/13F * 36CM BRAND: BSC. 3. WAS THE ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE?--- METAL CANNULA. 4. DID THE PHYSICIAN ENCOUNTER ANY RESISTANCE WHILE ADVANCING THE ZIPWIRE TO ITS INTENDED LOCATION?---NO. 5. DID THE PHYSICIAN ENCOUNTER ANY RESISTANCE WHILE REMOVING THE ZIPWIRE?---YES. 6. WERE THERE ANY PATIENT COMPLICATIONS DUE TO THE REPORTED MALFUNCTION?---NO. 7. DID ANY PART OF THE GUIDEWIRE DETACH INSIDE THE PATIENT?---NO. 8. IS THE METAL CORE WIRE EXPOSED?---YES. 9. BY "COATING WAS DETACHED" DID YOU MEAN THE PTFE PEELED?---YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708281 ↗
• MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION PROVIDED 27 DECEMBER 2025: 1. IMAGE PROVIDED. 2. DID THE END-USER HYDRATE THE ZIPWIRE PRIOR TO "UNPACKING" AS INSTRUCTED IN THE IFU? IT HASN'T REACHED THE STAGE OF "HYDRATE THE ZIPWIRE". WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE COATING PEELED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707961 ↗
• MalfunctionNov 20, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  ADDITIONAL INFORMATION PROVIDED 15 JANUARY 2026: 1. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. THE PROCEDURE WAS A PCNL WHEN THEY USED OUR GUIDEWIRE. THE BRAND OF THE NEPHROSCOPE IS FROM WULLF , 24 FR AND IT'S A NEW ONE. THEY BOUGHT IT 4 MONTHS AGO. 2. WAS THE ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE? THE WIRE WAS ADVANCED THROUGH OUR OWN ACCESS DEVICE CALLED NAVIGUIDE PERCUTANEOUS ACCESS NEEDLE (18G X 20 CM). 3. IS PATIENT INFORMATION AVAILABLE - AGE, GENDER, WEIGHT? NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604937 ↗
• MalfunctionNov 17, 2025Contamination; No Apparent Adverse Event; Contamination; No Apparent Adverse Event

  PRODUCT COMPLAINT DESCRIPTION: HAIR INSIDE THE PACKAGE. THEREFORE, NOT USABLE FOR STERILE PROCEDURES. LOT - OR BATCH NUMBER: JRZ9732710. ADDITIONAL INFORMATION PROVIDED 10 NOVEMBER 2025: 1. IS THERE AN IMAGE OF THE REPORTED DEFECT? NO BUT THERE IS THE SAMPLE. 2. WAS THE PACKAGING POUCH OPENED? NO. 3. WAS THE HAIR FOUND INSIDE THE STERILE POUCH? YES. 4. WAS THE DEVICE STERILITY COMPROMISED? THERE WAS A HAIR, I ASSUME YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577484 ↗
• MalfunctionOct 21, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE TIP OF THE GUIDEWIRE WAS FOUND BENT WHEN THE UNPACKAGED THE DEVICE IN PREPARATION FOR PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. PATIENT CONDITION FOLLOWING PROCEDURE - STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: NONE PATIENT OUTCOME FROM THE EVENT: NONE EVENT RESOLVED? - YES IMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348924 ↗
• MalfunctionOct 20, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE TIP OF THE GUIDEWIRE WAS FOUND TO BE BENT AND THE COATING PEELED OFF WHEN THE PACKAGE WAS OPENED IN PREPARATION FOR PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES. IMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337955 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  AN IMAGE AND ADDITIONAL INFORMATION PROVIDED 14 NOVEMBER 2025: 1. IS THERE A PHOTO OF THE COMPLAINT DEVICE? ---YES, SEE THE ATTACHMENT FOR DETAILS. 2. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.? ---UNKNOWN PER CUSTOMER 3. IT WAS MENTIONED IN THE ATTACHED REPORT THAT THE PROBLEM OF THE DEVICE WAS NOTICED DURING UNPACKING AND IT WAS ALSO MENTIONED THAT THE PROBLEM OCCURRED INSIDE THE PATIENT. COULD YOU PLEASE CLARIFY AS TO WHEN (UNPACKING, PREPARATION, INTRODUCTION/INSERTION, ADVANCEMENT, DURING PROCEDURE, WITHDRAWAL) AND WHERE (INSIDE THE PATIENT, OUTSIDE THE PATIENT) THE EVENT OCCURED? ---WHEN UNPACKED IN ITS INTACT STATE, IT WAS DISCOVERED DURING THE PROCEDURE THAT THE COATING HAD SEPARATED AND WAS LOCATED OUTSIDE THE PATIENT'S BODY. 4. WAS ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE? --- AFTER THE PACKAGING WAS UNPACKED, THE DEVICE LOOKED EXACTLY LIKE THE PICTURE. THIS DEVICE HAS NOT BEEN INSERTED INTO THE PATIENT'S BODY! 5. BY "THE GUIDEWIRE WAS DETACHED", DO YOU MEAN THE TIP WAS DETACHED?---NO, AS SHOWN IN THE IMAGE, THE MIDDLE PART OF THE DEVICE WAS SEPARATED. 6. DID ANY PART OF THE GUIDEWIRE DETACH INSIDE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294913 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: AFTER UNPACKED, IT WAS FOUND THAT THE COATING ON THE TIP OF THE GUIDE WIRE WAS FELL OFF. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE WHEN WAS THE PROBLEM NOTICED: UNPACKING WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE EVENT RESOLVED? YES IMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23284046 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: THE TIP OF THE GUIDE WIRE WAS FOUND TO BE BENT WHEN THE PACKAGE WAS OPENED IN PREPARATION FOR PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. WHAT WAS THE PATIENT CONDITION FOLLOWING PROCEDURE? STABLE. WHEN WAS THE PROBLEM NOTICED: UNPACKING. WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE. EVENT RESOLVED? YES. IMAGE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280591 ↗
• MalfunctionApr 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT DESCRIPTION: IT WAS REPORTED THAT: THE COATING WAS DAMAGED. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE, PATIENT CONDITION FOLLOWING PROCEDURE - STABLE, WHEN WAS THE PROBLEM NOTICED: UNPACKING, PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE, WHERE DID THE PROBLEM OCCUR? OUTSIDE THE PATIENT, ACTION TAKEN BY THE PHYSICIAN TO TRY TO RESOLVE THE EVENT: NONE, PATIENT OUTCOME FROM THE EVENT: NONE, EVENT RESOLVED? YES. ADDITIONAL INFORMATION PROVIDED 21 APRIL 2025: 1. IS THERE A PHOTO OF THE COMPLAINT DEVICE? NO. 2. WAS THE PTFE PEELED AT THE DISTAL END OF THE GUIDEWIRE? THE DEALER ONLY SAID, "THE TIP". TRIED TO FURTHER VERIFY, BUT DID NOT ANSWER ANYMORE. 3. WAS THERE ANY DETACHMENT OBSERVED ON THE GUIDEWIRE? YES, BUT NOT FALLEN INTO THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885509 ↗