MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; UROLOGICAL CATHETER AND ACCESSORIES

Model Number	M006630209B1
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
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.The procedure was identified as insertion of vascular port.As noted in the device instructions for use (dfu) indications for use, "the zipwire hydrophilic guidewire is intended to facilitate the placement of endourological instruments during diagnostic or interventional procedures.The zipwire hydrophilic guidewire is not intended for coronary artery, vascular or neurological use." the device instructions for use warnings section indicates, "do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle.Manipulation, advancement and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval.If a needle is used for initial placement, a plastic entry needle is recommended when using the zipwire hydrophilic guidewire." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, clinical and/or procedural factors appear to have impacted on the event as reported.The patient information was not provided at the time of this report.If there is any further relevant information received, a follow up medwatch report will be submitted.
Event or Problem Description
After completion of procedure the patient chest xray was abnormal.When the zipwire was retrieved, inspected, and compared to a new unused zipwire it was noted that a very thin part of the coating was missing.Patient was brought back to surgery to remove foreign body from the guidewire that was seen on post-op xray.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 10734993
• Report Number: 2126666-2020-00079
• Device Sequence Number: 19703803
• Product Code: EYA
• UDI-Device Identifier: 08714729761730
• UDI-Public: 08714729761730
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: M006630209B1
• Device Catalogue Number: 630-209B
• Device Lot Number: 11127852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention