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

Model Number	M006630222B1
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As received, the specimen consisted of one-1 each hydro gw stf std s 150-035; returned coiled loose with the j-straightener loaded over the wire, accompanied by the labeled portion of the packaging pouch within a separate small "zip-lock" style poly pouch, and single-bagged within a large "zip-lock" style poly biohazard pouch with documentation stapled to the outer pouch, compromising the protective pouch barrier.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 (b)(4) and was determined to be acceptable.The returned specimen presented a ductile, tensile overload separation of the polymer jacket material at the distal tip and cut/skive damage located 18.80 to 35.05cm from the distal tip in a proximal to distal orientation, with 3.10cm of the polymer jacket material distal of the cut/skive advanced distally over itself exposing 3.20cm of the metallic core wire.The overlapping polymer jacket region created a localized oversized diameter to.03835".The specimen also presented serpentine bend damage over the distal 37.3cm, consistent with tensile loading.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.The damage presented by the specimen appeared consistent with manipulation against resistance within a device with a higher durometer that the polymer jacket material.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.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.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, clinical and/or procedural factors appear to have impacted on the event as reported.The patient information was not provided at the time of this report.Requests for further information has been submitted; however, at the time of this report no further information has been received.If any further relevant information is received, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: per email, it was reported that: coating on guidewire came off inside patient.Physician was able to thoroughly irrigate patient to remove lost coating.

• 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: 11578368
• Report Number: 2126666-2021-00009
• Device Sequence Number: 3460410
• Product Code: EYA
• UDI-Device Identifier: 08714729755326
• UDI-Public: 08714729755326
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 09/30/2023
• Device Model Number: M006630222B1
• Device Catalogue Number: 630-222B
• Device Lot Number: 5924398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1