MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLES; BIOPSY INSTRUMENT

Model Number	C2020A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer; however photos were provided and a photo review will be performed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during a ct-guided lung biopsy, fragment of the coaxial sheared off into the patient.Cat scan confirmed that three inches of the coaxial got stuck inside the rib.It was further reported that surgical intervention was performed to remove the needle fragment.Post surgery, there were no signs of pneumothorax and the patient's condition was stable.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: although the sample was not returned for full evaluation, five electronic photos were provided for review.Based on the photo review, the reported needle detachment can be confirmed.The photos confirm the coaxial to be in three segments.Per the reported event details, the patient coughed and a fragment of the coaxial sheared off.While a definitive root cause could not be determined based upon available information, it is likely that patient factors contributed to the reported event.It is unknown if other procedural factors may have also contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 02/2021.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during a ct-guided lung biopsy, fragment of the coaxial sheared off into the patient.Cat scan confirmed that three inches of the coaxial got stuck inside the rib.It was further reported that surgical intervention was performed to remove the needle fragment.Post surgery, there were no signs of pneumothorax and the patient's condition was stable.

• Brand Name: BARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLES
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7644086
• Report Number: 2020394-2018-01002
• Device Sequence Number: 1861078
• Product Code: FCG
• UDI-Device Identifier: 00801741085123
• UDI-Public: (01)00801741085123
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2020A
• Device Catalogue Number: C2020A
• Device Lot Number: RECQ0600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 81