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

Catalog Number	C1410B
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy procedure, the biopsy gun was allegedly not removed from the patient because it was stuck in the end of guide needle.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.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.H11: section a through f: the information provide by bd represents all 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one marquee disposable core biopsy instrument with one loaded truguide coaxial cannula was received for evaluation.During visual evaluation, the marquee device appeared to have blood residue throughout the cannula.The penetration depth marker was set to 25mm.The marquee device was half-energized revealing the sample notch.Material deformation was noted to the distal end of the truguide and the distal end of the sample notch.The distal end of the sample notch was noted to be split.Due to the nature of the device, no functional testing was performed.Therefore, the investigation is confirmed for the reported difficult to remove as the instrument was unable to be removed from the coaxial.And the investigation is confirmed for the identified material deformation was noted to the distal end of the truguide and the distal end of the sample notch.However, the investigation is inconclusive for the reported device-device incompatibility as no objective evidence was provided for review.A definitive root cause for the reported difficult to remove, reported device-device incompatibility and identified material deformation issues could not be determined based upon the provided information.Labeling review: per the bard truguide disposable coaxial biopsy needle instructions for use (ifu - baw1280500, rev.4) how supplied section, c1410b is compatible with bard biopsy needle (magnum and biopty-cut).Per the bard marquee disposable core biopsy instrument instructions for use (ifu - baw1568700 rev.1) the bard marquee disposable core biopsy instrument is available as a biopsy instrument only and as a kit, which includes the bard marquee disposable core biopsy instrument and compatible coaxial biopsy needle.G3, h6 (device, component, method, result).Section a through f: the information provide by bd represents all 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.
Event or Problem Description
It was reported that during a biopsy procedure, the biopsy gun was allegedly not removed from the patient because it was stuck in the end of guide needle.There was no reported patient injury.

• Brand Name: TRUGUIDE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21122238
• Report Number: 2020394-2024-01984
• Device Sequence Number: 7436550
• Product Code: FCG
• UDI-Device Identifier: 00801741084898
• UDI-Public: (01)00801741084898(17)270430(10)REJS0345
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C1410B
• Device Lot Number: REJS0345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown