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

Model Number	GTIN 08714729761716
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an attempted ultrasound guided port placement with flouroscopy a portion of the guidewire sheath frayed and separated from the guidewire, resulting in a retained section of the sheath in the patient's jugular vein.Fda safety report id # (b)(4).

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL
• MDR Report Key: 11613150
• Report Number: MW5100540
• Device Sequence Number: 3291220
• Product Code: DQX
• UDI-Device Identifier: 08714729761716
• UDI-Public: (01)08714729761716(17)220531(10)
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: 05/31/2022
• Device Model Number: GTIN 08714729761716
• Device Catalogue Number: M006630205B0
• Device Lot Number: 11151611
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 57 YR