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

Model Number M006630200B0

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/18/2021

Event Type  malfunction  

Event Description

Fragment of the glidewire used to place the r subclavian cvl sheared off the device and was retained in the central venous system following the procedure.

• 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: 12369865
• MDR Text Key: 268232452
• Report Number: 12369865
• 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: 08/20/2021

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: M006630200B0
• Device Catalogue Number: M006630200B0
• Device Lot Number: 6090560
• 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: 08/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other