MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M00146152B0
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: rt/supply coordintor was restocking her procedure rooms after cases.She was going to put away the zip wire that she had just removed from the box.When she went to hang to the package on its hook the wire fell out because the package was open.Patient present at time of event?: no.Patient complications: no.Patient complications reason for unsuccessful procedure: na.Was the patient sedated when the procedure was cancelled?: no.
Additional Manufacturer Narrative
It was reported that the device was disposed.Therefore; no physical analysis of the device can be performed.During manufacturing the production operators are instructed to 100% visually and tactilely inspect for any obvious defect.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.This product receives a 100% verification of the seal by the production operator after the completion of each seal.The quality control inspectors are required to verify seal width, seal location, seal integrity and pouch appearance.There is a second on-line inspection performed by production during boxing.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.The history records indicate this product was final inspection tested and was determined to be acceptable.There was no patient involvement as this was detected by a supply coordinator during procedure room restock.Multiple attempts were made to obtain additional information.To date, no additional information has been provided.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 15304838
• Report Number: 9680001-2022-00110
• Device Sequence Number: 6360757
• Product Code: DQX
• UDI-Device Identifier: 08714729763901
• UDI-Public: 08714729763901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000011
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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 Model Number: M00146152B0
• Device Catalogue Number: 46-152B
• Device Lot Number: JRZ6680980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown