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

Model Number M006630205B0

Device Problem Break (1069)

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

Event Date 09/17/2021

Event Type  malfunction  

Event Description

The surgeon utilized a zipwire for access during a quinton catheter insertion.It was noted that the wire coating sheared off during access.The coating remained attached to wire upon removal, no coating was noted at the insertion site, and no foreign object or wire was noted on the c-arm x-ray.

• 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: 12567704
• MDR Text Key: 274468927
• Report Number: 12567704
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2021

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: M006630205B0
• Device Lot Number: 6146672
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 128