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

Model Number	M00146316B1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: per email, it was reported that: injury type: other during the procedure, it was found that the tip of the guide wire was peeling off, immediately replaced with a new guide wire, the patient continued treatment.Complaint summary: it was reported that the guidewire tip separation occurred.A guidewire was selected for use.However, during the procedure, it was found that the tip of the guide wire was peeling off.The procedure was completed with a different device.There were no patient complications nor injuries reported.Additional information received january 18, 2022: what was the name of the procedure(s) performed? only knew the procedure is for angiography.Was it the first time the device was used? yes.Was there visible damage to the device and/or its packaging prior to use? yes any resistance felt during insertion? no.Was the catheter stuck/locked on the guidewire? no or was there just significant resistance between the devices (not stuck)? no.Was the guidewire hydrated or rinsed with saline solution prior to removal from the dispenser? yes.Was there an issue with lubricity of the device? yes.Did the physician encounter any resistance while advancing the zipwire to its intended location? no.Did the physician encounter any resistance while removing the zipwire? yes.Was the zipwire advanced through a metal cannula or needle? none.Was the zipwire flushed during the procedure? yes did any part of the guidewire detach inside the patient? no.Is the metal core wire exposed? no is there an image available? 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 indicated in the device instructions for use, warnings: to prevent possible tissue damage, care should be taken when manipulating a device over a zipwire hydrophilic guide wire during the device's placement or withdrawal.If resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the zipwire hydrophilic guide wire and device as a unit to prevent possible damage and/or complications.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the zipwire¿ hydrophilic guide wire and/or catheter and determine the cause under fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter or damage to the vessel." the complaint is non-verifiable as the product was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that clinical and/or procedural factors impacted on the event as reported.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: 13337096
• Report Number: 9680001-2022-00002
• Device Sequence Number: 11787324
• Product Code: DQX
• UDI-Device Identifier: 08714729754862
• UDI-Public: 08714729754862
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2022

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: 02/12/2024
• Device Model Number: M00146316B1
• Device Catalogue Number: 41656
• Device Lot Number: JRZ6280983
• 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: 01/05/2022
• Initial Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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