ZIPWIRE¿
Report
- Report Number
- 9680001-2025-00008
- Event Type
- Injury
- Date Received
- May 14, 2025
- Date of Event
- March 10, 2025
- Report Date
- June 3, 2025
- Manufacturer
- LAKE REGION MEDICAL
- Product Code
- EYA
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THIS FOLLOW UP REPORT IS BEING FILED DUE TO RECEIPT OF ADDITIONAL EVENT INFORMATION. MULTIPLE SECTIONS OF THIS REPORT HAVE BEEN UPDATED. LOT TRACEABILITY WAS REPORTED AS UNKNOWN; THEREFORE, FIELDS WITHIN SECTION D4 COULD NOT BE COMPLETED, INCLUDING THE UDI NUMBER. IT WAS ALSO REPORTED THAT THE DEVICE "WAS NOT SAVED". THEREFORE, NO PHYSICAL ANALYSIS OF THE DEVICE CAN BE PERFORMED. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY AND TACTILELY INSPECT FOR ANY OBVIOUS DEFECT, WHICH INCLUDES A TACTILE EXAMINATION OF THE ENTIRE LENGTH OF EACH WIRE. IN ADDITION, DURING PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. THE ADDITIONAL INFORMATION INCLUDED AN IMAGE. THE PROVIDED IMAGE PRESENTED A POUCH LABEL OF ZIPWIRE; HOWEVER, IT WAS REPORTED THAT THE LABEL DID NOT BELONG TO THE ACTUAL COMPLAINT DEVICE. THE IMAGE WAS PROVIDED AS A REFERENCE TO ILLUSTRATE THE TYPE OF WIRE USED DURING THE EVENT. THE IMAGE ALSO PRESENTED AN UNDETERMINED LENGTH OF SKIVED/CUT POLYMER JACKET MATERIAL FROM THE ACTUAL COMPLAINT DEVICE. ADDITIONAL INFORMATION REPORTED USE OF A METAL SHEATH. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) WARNINGS: · DO NOT MANIPULATE, ADVANCE AND/OR WITHDRAW THE ZIPWIRE HYDROPHILIC GUIDEWIRE THROUGH A METAL CANNULA OR NEEDLE. MANIPULATION, ADVANCEMENT AND/OR WITHDRAWAL THROUGH A METAL DEVICE MAY RESULT IN DESTRUCTION AND/ OR SEPARATION OF THE OUTER POLYMER JACKET REQUIRING RETRIEVAL. IF A NEEDLE IS USED FOR INITIAL PLACEMENT, A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THE ZIPWIRE HYDROPHILIC GUIDEWIRE. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONE-WALL PUNCTURE STYLE NEEDLE. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) PRECAUTIONS: · THE ZIPWIRE HYDROPHILIC GUIDEWIRE SHOULD BE ADVANCED THROUGH THE SCOPE USING SHORT, DELIBERATE 2-3CM MOVEMENTS TO PREVENT INADVERTENT DAMAGE TO THE DEVICE OR PATIENT. · DUE TO VARIATIONS IN CERTAIN CATHETER TIP DIAMETERS, ABRASION OF THE HYDROPHILIC COATING MAY OCCUR DURING MANIPULATION. IF ANY RESISTANCE IS FELT DURING INTRODUCTION OF THE CATHETER, IT IS ADVISABLE TO STOP USING SUCH CATHETERS. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED AND THE EVIDENCE PRESENTED, IT APPEARED THAT PROCEDURAL AND/OR HANDLING FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED. IF ANY FURTHER RELEVANT INFORMATION IS PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED. NOTE: ALTHOUGH ANNEX G INSTRUCTIONS STATE THAT WITH STAND-ALONE DEVICES ANNEX G TERM SHOULD NOT BE USED, CODE 4755 WAS SELECTED DUE TO COMPONENT CODE (G) SHOWING UP ON THE MISSING DATA REPORT.
LIMITED INFORMATION WAS REPORTED. DESPITE ATTEMPTS TO GATHER ADDITIONAL EVENT DETAILS, INCLUDING PATIENT DETAILS, NO INFORMATION HAS BEEN PROVIDED TO DATE. IT WAS REPORTED THAT THE DEVICE IS NOT EXPECTED TO RETURN. IT WAS ALSO REPORTED THAT THE DEVICE AVAILABILITY IS UNKNOWN. THEREFORE, NO PHYSICAL ANALYSIS OF THE DEVICE CAN BE PERFORMED. ADDITIONALLY, THE LOT NUMBER FOR THE DEVICE WAS REPORTED AS UNKNOWN; THEREFORE, FIELDS WITHIN SECTION D4 COULD NOT BE COMPLETED, INCLUDING THE UDI NUMBER. ATTEMPTS WERE MADE TO OBTAIN INFORMATION ON THE SUSPECT MEDICAL DEVICE. TO DATE, ONLY THE MODEL/CATALOG NUMBER HAS BEEN PROVIDED. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THE PRODUCTION OPERATORS ARE INSTRUCTED TO 100% VISUALLY AND TACTICALLY INSPECT FOR ANY OBVIOUS DEFECT, WHICH INCLUDES A TACTILE EXAMINATION OF THE ENTIRE LENGTH OF EACH WIRE. IN ADDITION, DURING PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) OPERATIONAL INSTRUCTIONS: TO ACTIVATE HYDROPHILIC COATING: BEFORE REMOVING THE ZIPWIRE HYDROPHILIC GUIDEWIRE FROM THE PROTECTIVE HOOP (BY ITS DISTAL END), INJECT PHYSIOLOGICAL SALINE SOLUTION INTO THE HUB END OF THE HOLDER IN ORDER TO COMPLETELY WET THE SURFACE OF THE WIRE. USE OF ALCOHOL, ANTISEPTIC SOLUTIONS, OR OTHER SOLVENTS MUST BE AVOIDED, AS THEY MAY ADVERSELY AFFECT THE SURFACE OF THE WIRE. DO NOT WIPE THE ZIPWIRE HYDROPHILIC GUIDEWIRE WITH DRY GAUZE. BEFORE INSERTING THE ZIPWIRE HYDROPHILIC GUIDEWIRE THROUGH A CATHETER, FILL THE CATHETER WITH PHYSIOLOGICAL SALINE SOLUTION. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) WARNINGS: DO NOT MANIPULATE, ADVANCE AND/OR WITHDRAW THE ZIPWIRE HYDROPHILIC GUIDEWIRE THROUGH A METAL CANNULA OR NEEDLE. MANIPULATION, ADVANCEMENT AND/OR WITHDRAWAL THROUGH A METAL DEVICE MAY RESULT IN DESTRUCTION AND/ OR SEPARATION OF THE OUTER POLYMER JACKET REQUIRING RETRIEVAL. IF A NEEDLE IS USED FOR INITIAL PLACEMENT, A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THE ZIPWIRE HYDROPHILIC GUIDEWIRE. EXTREME CAUTION SHOULD BE OBSERVED WHEN USED WITH A ONE-WALL PUNCTURE STYLE NEEDLE. AS NOTED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) PRECAUTIONS: THE ZIPWIRE HYDROPHILIC GUIDEWIRE SHOULD BE ADVANCED THROUGH THE SCOPE USING SHORT, DELIBERATE 2-3CM MOVEMENTS TO PREVENT INADVERTENT DAMAGE TO THE DEVICE OR PATIENT. DUE TO VARIATIONS IN CERTAIN CATHETER TIP DIAMETERS, ABRASION OF THE HYDROPHILIC COATING MAY OCCUR DURING MANIPULATION. IF ANY RESISTANCE IS FELT DURING INTRODUCTION OF THE CATHETER, IT IS ADVISABLE TO STOP USING SUCH CATHETERS. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT PROCEDURAL AND/OR HANDLING FACTORS HAVE CONTRIBUTED TO THE EVENT AS REPORTED. IF ANY FURTHER RELEVANT INFORMATION IS PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED. NOTE: ALTHOUGH ANNEX G INSTRUCTIONS STATE THAT WITH STAND-ALONE DEVICES ANNEX G TERM SHOULD NOT BE USED, CODE 4755 WAS SELECTED DUE TO COMPONENT CODE (G) SHOWING UP ON THE MISSING DATA REPORT.
ADDITIONAL INFORMATION, INCLUDING IMAGES, CONFIRMED FOR EVENT ON (B)(6) 2025: PER EMAIL, IT WAS REPORTED THAT: I WAS MADE AWARE THAT DURING A PROCEDURE ON (B)(6) 2025 OUR PHYSICIAN EXPERIENCED AN ISSUE WITH A ZIPWIRE. THE PATIENT WAS UNDERGOING A PERCUTANEOUS NEPHROLITHOTOMY AND DURING A WIRE EXCHANGE, THE HYDROPHILIC COATING SHEARED OFF THE ZIPWIRE. THE PORTION PICTURED ON THE RIGHT BELOW REMAINED IN THE PATIENT. ATTEMPTS MADE DURING THE INITIAL SURGERY TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL. THREE ADDITIONAL SURGICAL ATTEMPTS INVOLVING SEVERAL HOURS WERE REQUIRED TO FINALLY EXTRACT THE PRODUCT ON (B)(6) 2025. THE PATIENT DID NOT SUFFER ANY PERMANENT HARM. THE ORIGINAL PACKAGING WAS NOT SAVED HOWEVER THE WIRE ON THE LEFT BELOW IS AN EXAMPLE OF WIRE THAT WAS USED. UNFORTUNATELY, I DON'T HAVE THE LOT# OF THE AFFECTED WIRE. 03 JUNE 2025 RECEIVED RESPONSES TO QUESTIONS: 1. WAS LASER EQUIPMENT USED DURING THE PROCEDURE? NO. 2. WAS THERE ANY ADDITIONAL DAMAGE DONE TO THE DEVICE DURING THE SEPARATE ATTEMPTS TO REMOVE THE FRAGMENT FROM THE PATIENT? NO. 3. WHAT METHOD WAS USED THAT SUCCEEDED IN THE REMOVAL OF THE FRAGMENT? STAGED LASER LITHOTRIPSY TO BREAK UP THE LARGE STONE FOLLOWED BY URETEROSCOPY TO RETRIEVE THE WIRE COATING. 4. DID THE ZIPWIRE COME IN CONTACT WITH ANY OTHER SHARP AND OR METAL DEVICES DURING THE PROCEDURE? HOLLOW NEEDLE SHEATH. 5. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. I AM STILL WAITING TO HEAR BACK FROM OUR OR CREW REGARDING ANY ADDITIONAL EQUIPMENT USED DURING THE PROCEDURE. I WILL FORWARD THAT INFORMATION TO YOU AS SOON AS I RECEIVE IT. 6. WAS THE ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE? YES, SHEATH. 7. ARE PATIENT DETAILS AVAILABLE? (AGE, WEIGHT, GENDER) 50Y/O FEMALE, 80KG. 8. WHAT IS THE REASON FOR NO PRODUCT RETURN? WAS NOT SAVED BY STAFF. HOWEVER, I DO HAVE THE HYDROPHILIC COATING RETRIEVED FROM THE PATIENT.
EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: PRODUCT QUALITY, BOSTON SCIENTIFIC, CATALOG NUMBER M0066802050, COID 34426 ZIPWIRE SHEATH FRAYED OFF THE WIRE AND REMAINED IN THE PATIENT. BOSTON SCI NOTIFIED AS WELL. THE FOLLOWING QUESTIONS WERE SUBMITTED ON 2 MAY 2025: 1. WHAT WAS THE NAME OF THE PROCEDURE(S) PERFORMED? 2. LISTING AND MODEL OF OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. 3. HOW WAS THE PROCEDURE(S) COMPLETED? (I.E. WAS THE SAME DEVICE EXCHANGED FOR ANOTHER OF THE SAME, DIFFERENT DEVICE, ETC.)? 4. IF THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT, ARE THERE ANY ADDITIONAL TREATMENT PLANS TO BE DONE IN THE FUTURE AS THIS PROCEDURE HAD TO BE TERMINATED? 5. WAS THE ZIPWIRE ADVANCED THROUGH A METAL CANNULA OR NEEDLE? 6. DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT OR WITHDRAWAL? A. DID THE PHYSICIAN ENCOUNTER ANY RESISTANCE AT THE TIME OF THE EVENT? 7. WHEN DID THE PHYSICIAN OBSERVE THE REPORTED DAMAGE? 8. WAS THERE AN ATTEMPT TO REMOVE THE "ZIPWIRE SHEATH"? 9. WHAT IS THE PATIENT'S CONDITION? 10. ARE PATIENT DETAILS AVAILABLE? (AGE, WEIGHT, GENDER) 11. WHAT IS THE REASON FOR NO PRODUCT RETURN? 9 MAY 2025, IT WAS REPORTED, "OUR APOLOGIES, WE DO NOT HAVE ANY ADDITIONAL INFORMATION. SO, THE RESPONSE IS THE ABOVE QUESTIONS WOULD BE "UNKNOWN" FOR ALL OF THEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1909790 | ZIPWIRE¿ | UROLOGICAL CATHETER AND ACCESSORIES | EYA | LAKE REGION MEDICAL | M0066802051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Required Intervention| O |