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

Model Number	M006630222B1
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of the event notification, questions were submitted to obtain clarification.This medwatch report is being filed based on the information and image received on (b)(6) 2022.The complaint device was not returned 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, "prior to use, inspect for damage.If damaged, do not use." the customer supplied image presented polymer jacket separation damage at the distal tip region.At this time, it is not possible to assign a definitive root cause for the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
It was reported that the tip of guide wire had no support force.The device is expected to be returned before (b)(6).There were no patient complications reported.What was the patient condition following procedure? stable.Event resolved? yes.Additional information and an image of the device were provided on (b)(6) 2022: it possibly be that the coating of the tip of guidewire fell off during the use of the guide wire, resulting in poor or no support force of the guide wire head end.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each hydro gw stf std s 150-035; returned loaded into the dispenser assembly and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented an overall length of 153.7 cm and a finished diameter of.03245" to.03365".The specimen presented skive/cut damage in a proximal to distal orientation located 22.1 cm to 47 cm from the distal tip, exposing approximately 18.5 cm of the metallic core wire.The specimen also presented the skived/cut polymer jacket material being displaced distally over itself for 2 cm at 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.Based on the information provided and the evidence presented, it appeared that clinical / handling factors have contributed to the event as reported.As noted in the device instructions for use (dfu) warnings: - do not manipulate or withdraw the zipwire hydrophilic guide wire through a metal entry needle or metal dilator.Manipulation and/or withdrawal through a metal entry needle or metal dilator may result in destruction and or separation of the outer polyurethane coating, requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.As indicated in device instructions for use, 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 of certain catheter tip inner 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 there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
It was reported that the tip of guide wire had no support force.The device is expected to be returned before sep.21st.There were no patient complications reported.What was the patient condition following procedure? stable event resolved? yes.The following questions were sent to obtain clarification: 1.Please explain what is meant by "no support force.".2.Is there an image of the reported damage/ deficiency? additional information and an image of the device were provided on september 9, 2022: it possibly be that the coating of the tip of guidewire fell off during the use of the guide wire, resulting in poor or no support force of the guide wire head end.

• 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): 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: 15462526
• Report Number: 2126666-2022-00037
• Device Sequence Number: 6757972
• Product Code: EYA
• UDI-Device Identifier: 08714729755326
• UDI-Public: 08714729755326
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 05/31/2024
• Device Model Number: M006630222B1
• Device Catalogue Number: 630-222B
• Device Lot Number: 6401323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 50 KG