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

Model Number	M00146236B1
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device was discarded; therefore, no physical analysis can be performed.Additionally, lot traceability was not provided.The lack of lot traceability prevents performing a device history records review for any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A review of the manufacturing processes indicates the production operators are instructed to 100% visually and tactually 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 customer supplied images of the device presented polymer jacket material removal exposing the core wire at an unknown distance from the distal tip.The images also presented the skived/cut polymer jacket material being displaced distally over itself at an unknown distance from the distal tip.As noted in the device instructions for use (dfu) preparation for use: the surface of the zipwire hydrophilic guide wire is not lubricious unless it is wet.Before removing the zipwire hydrophilic guide wire from its dispenser, inject sterile heparinized saline solution into the luer lock hub end of the dispenser using a syringe.Inject enough solution to fill the dispenser coil.This will completely cover the zipwire hydrophilic guide wire surface and activate the hydrophilic coating.Remove the zipwire hydrophilic guide wire from its dispenser by gently withdrawing the zipwire hydrophilic guide wire's tip.If the zipwire hydrophilic guide wire cannot easily be removed from its dispenser, inject more heparinized saline solution into the dispenser and try again.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 report will be submitted.
Event or Problem Description
Event description: opened package and the wire was exposed and missing its coating.Product was photographed then thrown away.Patient present at time of event?: no.Patient complications: no.Patient complications procedure date; unknown.Images provided july 5, 2023.
Additional Manufacturer Narrative
This medwatch follow up report is being filed due to lot traceability being provided.The following sections have been updated and/or corrected to reflect receipt of the lot number: sections d4, h4, h6 and h10.It was reported that the device was discarded; therefore, no physical analysis can be performed.A review of the device history records of the specimen device performed 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.The customer supplied images of the device presented polymer jacket material removal exposing the core wire at an unknown distance from the distal tip.The images also presented the skived/cut polymer jacket material being displaced distally over itself at an unknown distance from the distal tip.As noted in the device instructions for use (dfu) preparation for use: 1.The surface of the zipwire hydrophilic guide wire is not lubricious unless it is wet.Before removing the zipwire hydrophilic guide wire from its dispenser, inject sterile heparinized saline solution into the luer lock hub end of the dispenser using a syringe.2.Inject enough solution to fill the dispenser coil.This will completely cover the zipwire hydrophilic guide wire surface and activate the hydrophilic coating.3.Remove the zipwire hydrophilic guide wire from its dispenser by gently withdrawing the zipwire hydrophilic guide wire's tip.4.If the zipwire hydrophilic guide wire cannot easily be removed from its dispenser, inject more heparinized saline solution into the dispenser and try again.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 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: 17342857
• Report Number: 9680001-2023-00109
• Device Sequence Number: 6524047
• Product Code: DQX
• UDI-Device Identifier: 08714729765165
• UDI-Public: 08714729765165
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 01/09/2026
• Device Model Number: M00146236B1
• Device Catalogue Number: 41696
• Device Lot Number: JRZ7713786
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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