MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE¿; UROLOGICAL CATHETER AND ACCESSORIES

Model Number	M006630222B0
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: per email, it was reported that: the patient underwent ureteroscopic stent replacement procedure.When the guide wire was used during the proceure, the physician felt that there was resistance.After withdrawing the guide wire, the outer membrane was found to be folded and have some small defects.After verification and comparison by the nurse, the physician immediately removed the ureteroscope for flushing, removed the small outer membrane from the ureteroscope working channel, and replaced the guide wire.Analysis of cause of the event: product reasons(including manuals) analysis description of cause of the event: the patient underwent ureteroscopic stent replacement procedure.When the guide wire was used during the proceure, the physician felt that there was resistance.After withdrawing the guide wire, the outer membrane was found to be folded and have some small defects.After verification and comparison by the nurse, the physician immediately removed the ureteroscope for flushing, removed the small outer membrane from the ureteroscope working channel, and replaced the guide wire.The product was defective.Procedure outcome: the physician replaced it with a new guide wire.
Additional Manufacturer Narrative
A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing 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 history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As noted in the device instructions for use (dfu) warnings, · manipulate the zipwire hydrophilic guidewire slowly and carefully in the urinary system while confirming the behavior and location of the wire's tip under fluoroscopy.Excessive manipulation of the zipwire hydrophilic guidewire without fluoroscopic confirmation may result in perforation or trauma of the linings or associated tissues, channels or ducts.If any resistance is felt or if the tip's behavior and/or location seem improper, stop manipulating the wire and/or catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the zipwire hydrophilic guidewire's tip, damage to the catheter, or damage to the urinary system.If necessary, remove the zipwire hydrophilic guidewire and ancillary device or scope as a complete unit to avoid complications.The dfu precautions also indicate, · the surface of the zipwire hydrophilic guidewire is not lubricious unless it is wet.Before taking it out of its holder and inserting it through a catheter, fill the holder and the catheter with sterile physiological saline solution.· 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.The complaint is non-verifiable as the product was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appeared that clinical and/or procedural factors have contributed to the event as reported.If any further information is received, a follow up medwatch report will be submitted.

• Brand Name: ZIPWIRE¿
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 19617994
• Report Number: 2126666-2024-00043
• Device Sequence Number: 6963148
• Product Code: EYA
• UDI-Device Identifier: 08714729764274
• UDI-Public: (01)08714729764274(17)230831(10)5890621
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: M006630222B0
• Device Catalogue Number: M006630222B0
• Device Lot Number: 5890621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male