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

Model Number	41657
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: zipwire coating was sticky throughout the case per the tech, and physician.Upon advancing rubicon over zipwire past tibial lesion.The zipwire was being removed to advance a rota wire in its place to perform tibial atherectomy.The zipwire did not want to come out of the rubicon.After some firm tension from doctor the zipwire was finally removed with the proximal portion of the wire appearing stretched and coating had separated as well.A negative was pulled on the rubicon with a flush syringe which showed no coating in the syringe.Extensive fluoro of the extremity was performed to make sure no portions of the wire remained though it appeared intact upon removal.After this the procedure was completed successfully performing rotablation and balloon angioplasty.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: n\a.What is the net course of action?: n\a.Patient present at time of event?: yes.Patient complications: no patient complications additional information received on (b)(6) 2022: - was this the first time the device was used (not resterilized or reprocessed)? yes, this was the first time the wire was used.It was not a reprocessed wire.- per the salesforce complaint form (cipi form), the batch/lot number is unknown.Can you please confirm if this information is unknown per customer? if this information is still available, please provide the correct batch/lot number of the zipwire: i do have the lot of the other wires they were pulling from.So it's possible the wire was from this lot: jrz6982546 i also was talking with the scrub tech, and he believes it is possible that there could have been a knick in the wire from the introducer needle.The physician uses the zipwire to obtain access with the percutaneous needle at the beginning of the case.Which would also make since on where the issue was located on the wire.
Additional Manufacturer Narrative
It was reported that the device was disposed; 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.The complaint narrative states, "after some firm tension from doctor the zipwire was finally removed with the proximal portion of the wire appearing stretched and coating had separated as well." additional information event information provided on (b)(6) 2023 stated, "i also was talking with the scrub tech, and he believes it is possible that there could have been a knick in the wire from the introducer needle.The physician uses the zipwire to obtain access with the percutaneous needle at the beginning of the case.Which would also make since on where the issue was located on the wire." as indicated in the device instructions for use, 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.- 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." 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: 16147515
• Report Number: 9680001-2023-00100
• Device Sequence Number: 17852174
• Product Code: DQX
• UDI-Device Identifier: 08714729764144
• UDI-Public: 08714729764144
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/12/2023

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: 01/26/2025
• Device Model Number: 41657
• Device Lot Number: JRZ6982546
• 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: 12/26/2022
• Initial Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male