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

Model Number	M006630209B0
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
After completion of procedure (insertion of vascular port) a chest xray was performed.Results suspected retained foreign body.The zipwire used in the case was retrieved and inspected.When compared to a new (unused) zipwire, it was noted that a very thin part of the coating was missing.The patient was returned to surgery and an approximately 15 cm piece of the guidewire was retrieved.Fda safety report id# (b)(4).

• Brand Name: ZIPWIRE STANDARD HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; chaska MN 55318
• MDR Report Key: 10657915
• Report Number: MW5097168
• Device Sequence Number: 3093941
• Product Code: DQX
• UDI-Device Identifier: 08714729761730
• UDI-Public: 08714729761730
• Initial Reporter State: LA
• 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): 10/06/2020

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: 02/28/2022
• Device Model Number: M006630209B0
• Device Catalogue Number: M006630209B0
• Device Lot Number: 11127852
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2020
• 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
• Patient Age: 65 YR
• Patient Weight: 93