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

Model Number	M0066802081
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: the distal 10 cms of the guidewire became detached, but nothing was left in the patient.The wire broke when it was being removed.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: n/a.Patient present at time of event?: yes.Patient complications: no patient complications.Additional information received on december 21, 2022: 1.Was the zipwire advanced through a metal cannula or needle? no.2.Was the zipwire and companion device flushed during the procedure? yes.3.Did the physician encounter any resistance while removing the zipwire? slight.4.What method was used to retrieve the detached fragment? a basket.5.How was the procedure completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? opened another of the same device.6.Has the device been reprocessed/resterilized? no.
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, "if any resistance is felt or if the tip's behavior and/or location seems 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." 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: the distal 10 cms of the guidewire became detached, but nothing was left in the patient.The wire broke when it was being removed.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: n/a.Patient present at time of event?: yes.Patient complications: no patient complications.Additional information received on december 21, 2022: 1.Was the zipwire advanced through a metal cannula or needle? no.2.Was the zipwire and companion device flushed during the procedure? yes.3.Did the physician encounter any resistance while removing the zipwire? slight.4.What method was used to retrieve the detached fragment? a basket.5.How was the procedure completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? opened another of the same device.6.Has the device been reprocessed/resterilized? no.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each hydro gw stf s 150-038; returned reloaded with in dispenser assembly and accompanied by the recovered, detached polymer jacket material from the clinical event and triple-bagged within "zip-lock" style poly pouches.The specimen presented an overall length 150.3cm and a finished diameter of.03540" to.03735".The specimen presented skive/cut damage in a proximal to distal orientation located 4.7 cm to 26.4 cm from the distal tip in a proximal to distal orientation and indications of torsional loading (twist), exposing metallic core wire.The specimen also presented skive/cut damage with material removal at 28.3cm to 29.6cm from the distal tip.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.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.Based on the information provided and the evidence presented, it appeared that handling and/or procedural factors have contributed to the event as reported.As noted in the device instructions for use (dfu) warnings, if any resistance is felt or if the tip's behavior and/or location seems 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.If any further information is received, a follow up medwatch report will be submitted.

• 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
• Manufacturer (Section G): VENUSA DE MEXICO S. DE R.L. DE C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 16054658
• Report Number: 9680001-2022-00117
• Device Sequence Number: 15062173
• Product Code: EYA
• UDI-Device Identifier: 10816349011785
• UDI-Public: 10816349011785
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 04/30/2025
• Device Model Number: M0066802081
• Device Lot Number: JRZ7164030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown