MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD RECOVERY CONE REMOVAL SYSTEM

Catalog Number FBRC

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

Event Description

During a procedure to remove a fractured 2 pieces of a inferior vena cava (ivc) retrieval tool was examined and radiopaque ring from the ivc filter retrieval tool was noted missing from the tool.The rest of the procedure was completed to remove a large dvt from the pt's left iliac vein.

• Brand Name: BARD RECOVERY CONE REMOVAL SYSTEM
• Type of Device: BARD RECOVERY CONE REMOVAL SYSTEM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 6157612
• MDR Text Key: 62152431
• Report Number: MW5066597
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Public: +$$900001517151GFYD27200N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: FBRC
• Device Lot Number: GFYD2720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 1% LIDOCAINE (ML): 20 ML; BENADRYL 25 MG IV; FENTANYL (MCG) 150 MICROGRAMS; VERSED (MG): 2MG
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Weight: 81