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	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: per cnf, it was reported that: we have used zipwire stiff 260cm with the guidance & rubicon catheter to pass a lesion in femoral loop graft, there was an abnormality noticed in the wire become exposed from the outer layer which hinder its unsafe in the operation & become malfunction , so usage of another one wire was a must.Additional information received november 14, 2022: 1.Per event, "there was an abnormality noticed in the wire become exposed from the outer layer which hinder its unsafe in the operation".Please clarify if the coating of the wire was peeled off? or just unravelled? no, there was not an abnormality noticed in the wire(just unravelled).2.When was the issue noted? (during procedure, preparation, etc) please specify.During procedure.3.How was the procedure completed (with another of same device, with a different device, etc.)? please specify.With a different device.4.What was the patient's condition post procedure? (stable, fine good, etc) good.5.Please provide lesion characteristics: tortuosity? (not tortuous, mild, moderate, severe) mild tortuosity.The following characteristics were requested, but not provided: % stenosis, calcification (not calcified, mild, moderate, severe) and significant bend (< 45 degrees? <90 degrees? >90 degrees).6.What was the name of the procedure(s) performed? angioplasty.7.Was the purpose of the procedure for treatment or diagnosis? treatment.8.Listing and model of other devices used during the procedure? rubicon, mustang.9.Was there visible damage to the device and/or its packaging prior to use? no.10.When in the procedure did the issue occur?: during insertion, advancement or withdrawal? advancement.11.Any resistance felt during insertion? no.12.Was the guidewire hydrated or rinsed with saline solution prior to removal from the dispenser? yes.13.Was the zipwire flushed during the procedure? yes.14.Was the zipwire advanced through a metal cannula or needle? no.15.How was the procedure(s) completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? different device.16.Where on the wire was the damage? middle.17.Did any part of the guidewire detach inside the patient? no.18.Is the metal core wire exposed? yes.19.Were there any patient complications during the procedure(s) or after as a result of the product issue? no.20.Is there an image available? no.
Additional Manufacturer Narrative
It was reported that the device will not return for evaluation; 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: "manipulate the zipwire hydrophilic guide wire slowly and carefully in the vessel while confirming the behavior and location of the wire's tip under fluoroscopy." and "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 by fluoroscopy." 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: 15815726
• Report Number: 9680001-2022-00115
• Device Sequence Number: 7027829
• Product Code: DQX
• UDI-Device Identifier: 08714729754862
• UDI-Public: 08714729754862
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 11/17/2022

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: 10/04/2024
• Device Model Number: M00146316B1
• Device Catalogue Number: 41656
• Device Lot Number: JRZ6696499
• 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: 11/02/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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 Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 110 KG