MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE; TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH

Model Number M006630208B0

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

Zipwire general-purpose non-vascular guidewire was being used to guide into the patient right ureter for a stent exchange and lithotripsy.The zipwire guidewire was found to be severed, confirmed through fluoroscopy.The guidewire was retrieved immediately by the surgeon, and the stent was placed as planned.No harm to the patient was identified, only extending the length of the surgery.

• Brand Name: ZIPWIRE
• Type of Device: TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH
• Manufacturer (Section D): LAKE REGION MEDICAL; 13024 north main st; trenton GA 30752
• MDR Report Key: 11892878
• MDR Text Key: 252966232
• Report Number: 11892878
• Device Sequence Number: 1
• Product Code: GYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2021

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
• Device Operator: Health Professional
• Device Model Number: M006630208B0
• Device Catalogue Number: M006630208B0
• Device Lot Number: 5975145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Date Report to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA