MAUDE Adverse Event Report: BARD PHERIPHERAL VASCULAR, INC. OSTYCUT 2.0MM 14.5 GAUGE X 150MM LONG; DISPOSABLE BONE BIOPSY NEEDLE

Lot Number ANAX0820

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/17/2018

Event Type  Injury  

Event Description

Pt having ct guided rib biopsy.Toward the end of the procedure as dr was attempting to remove 14.5g ostycut biopsy trocar from her densely sclerotic clavicle the distal 2mm of the beveled tip broke off within th intramedullary portion of her clavicular head.The packaging of the device was saved and we will report the device malfunction to the mfr.The tip was confirmed completely within the cortex of the bone and was the size of a pencil tip.There was no extracortical extension into her surrounding tissues.Giving this benign positioning, the trocar tip was left in place with no attempt at retrieval.

• Brand Name: OSTYCUT 2.0MM 14.5 GAUGE X 150MM LONG
• Type of Device: DISPOSABLE BONE BIOPSY NEEDLE
• Manufacturer (Section D): BARD PHERIPHERAL VASCULAR, INC.; tempe AZ 85281
• MDR Report Key: 7446287
• MDR Text Key: 106163966
• Report Number: MW5076563
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ANAX0820
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR