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

Model Number	C2010A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.(expiry date: 12/2021).
Event or Problem Description
It was reported that during a ct guided lung biopsy, the device allegedly broke off inside the patient.The patient was then transferred to the or where the device was successfully removed.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: one truguide coaxial needle was returned with two labels and three sealed lot samples.No anomalies were noted to the lot samples provided.Two electronic photos were also provided for review.The hub of the original truguide sample was returned attached to a three-way valve.A visual inspection of the original device as well as the photo review confirmed that the hub and cannula needle had separated.As such, the investigation is confirmed for the reported break.Per the reported event details and based on the evaluation results, a three-way valve of unknown origin was attached to the truguide hub during the procedure to aspirate air during the procedure.As such, it is possible that conditions of use contributed to the reported break.However, the definitive root cause could not be determined based upon available information.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.
Event or Problem Description
It was reported that during a ct guided lung biopsy, the device allegedly broke off inside the patient.The patient was then transferred to the or where the device was successfully removed.

• Brand Name: BARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8725106
• Report Number: 2020394-2019-01140
• Device Sequence Number: 1684688
• Product Code: FCG
• UDI-Device Identifier: 00801741085079
• UDI-Public: (01)00801741085079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: C2010A
• Device Catalogue Number: C2010A
• Device Lot Number: REDN4428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 04/28/2020
• 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