MAVIG LEAD SHIELD 0T25U01 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-05 for MAVIG LEAD SHIELD 0T25U01 * manufactured by Ti-ba Enterprises.

Event Text Entries

[18560526] Patient was on the cath lab table (room 1) and the procedure was approx 2/3 complete when the lead shield suddenly broke from its support arm and crashed to the floor. No one was hurt, but the shield did come close to falling on the pt and the physician performing the procedure. The lead shield was in a stationary position at the time of the event and according to the staff had been moved for positioning two times during the procedure up to the point of breaking off. The ge representative, happened to be in the cath lab area doing maintenance on cath room #2. The incident was reported to them as well. Pt does not know of any history associated with other incidents with this product. It appears that the extension arm of the shield broke at a "weld point" on the first elbow of the swing arm. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working). Other devices in use on patient: no, the patient was on the cath lab table while the cardiologist and team were doing a cath procedure on the patient. The lead shield broke from its support arm and fell to the floor, missing the patient and staff member nearby.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 504190
• MDR Report Key: 504190
• Date Received: 2004-01-05
• Date of Report: 2003-10-01
• Date of Event: 2003-10-01
• Date Added to Maude: 2004-01-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MAVIG LEAD SHIELD
• Generic Name: LEAD SHIELD USED ON G.E. BI-PLANE CATH UNIT
• Product Code: KPY
• Date Received: 2004-01-05
• Model Number: 0T25U01
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 28 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 492982
• Manufacturer: TI-BA ENTERPRISES
• Manufacturer Address: 25 HYTEC CIRCLE ROCHESTER NY 14606 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-01-05