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

Model Number	M006630208B1
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation at the time of this report; therefore, no physical analysis of the device can be performed.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, 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 needle.Use extreme caution when using a laser, making sure to avoid contact with the zipwire hydrophilic guidewire.Direct contact may cause damage to the wire and/or sever the wire.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 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.If any further information is received, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: per medwatch, it was reported that: zipwire general-purpose non-vascular guidewire was being used to guide into the patient right ureter for a stent exchange and lithotripsy.The zipwire guidewire was found to be severed, confirmed through fluoroscopy.The guidewire was retrieved immediately by the surgeon, and the stent was placed as planned.No harm to the patient was identified, only extending the length of the surgery.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12003943
• Report Number: 2126666-2021-00018
• Device Sequence Number: 14279194
• Product Code: EYA
• UDI-Device Identifier: 08714729764267
• UDI-Public: 08714729764267
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 10/31/2023
• Device Model Number: M006630208B1
• Device Catalogue Number: 630-208B
• Device Lot Number: 5975145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR