MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUEGUIDE COAXIAL; DISPOSABLE BIOPSY

Model Number	C2016B
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation, however photo was provided for review.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2022).
Event or Problem Description
It was reported that during an ct guided biopsy procedure, the coaxial needle allegedly broken inside the patient.It was further reported that a fragrant of coaxial needle about 2.5 mm left on inside the patient on anterior mediastinal fat, perpendicular to the aortic arch and close to the posterior cortex of the sternum.Reportedly additional intervention is required to remove the fragment.Patient status was unknown.
Event or Problem Description
It was reported that during an ct guided biopsy procedure, the coaxial needle allegedly broken inside the patient.It was further reported that a fragrant of coaxial needle about 2.5 mm left on inside the patient on anterior mediastinal fat, perpendicular to the aortic arch and close to the posterior cortex of the sternum.Reportedly additional intervention is required to remove the fragment.Patient status was unknown.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.Provided photo shows the broken needle part in a container.Therefore, based on the photo review, the reported broken needle can be confirmed.A definitive root cause for the alleged coaxial needle broken could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date: 08/2022 section a through f - the information provided by bd 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 bd.

• Brand Name: TRUEGUIDE COAXIAL
• Common Device Name: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11573403
• Report Number: 2020394-2021-00689
• Device Sequence Number: 19588284
• Product Code: FCG
• UDI-Device Identifier: 00801741085116
• UDI-Public: (01)00801741085116
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: C2016B
• Device Catalogue Number: C2016B
• Device Lot Number: REDW0662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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: 61 YR
• Patient Weight: 50