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

Catalog Number	C2016A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a computed tomography guide pelvic abscess biopsy using the coaxial biopsy needle.During the procedure, it was reported that the needle allegedly broke at 4 cm.The 8cm needle piece remained inside the patient and required surgical intervention to remove.However, the current patient status unknown.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent a computed tomography guided pelvic abscess biopsy using the coaxial biopsy needle.During the procedure, it was reported that the needle allegedly broke at 4 cm.The 8cm needle piece remained inside the patient and required surgical intervention to remove.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one truguide coaxial cannula in three segments was received for evaluation.Upon visual and microscopic evaluation, the truguide coaxial cannula appeared to have blood residue throughout.The distal end of the attached cannula segment appeared to be compressed.The second cannula segment was returned.The proximal end of the second cannula segment appeared to be compressed.The distal end of the second cannula segment appeared to be compressed.Multiple breaks were noted to the truguide needle.The proximal end of the third needle segment was noted to be pinched.Due to the break, no functional testing was performed.Therefore, the investigation is confirmed for the reported break issue as multiple breaks were noted to the truguide needle.And the investigation is confirmed for the identified improper or incorrect procedure or method as the device was used against the indication of use.A definitive root cause for the reported break issue is unknown and identified improper or incorrect procedure is determined to be use related.Labeling review: based on the provided information the usage of device is against the indications of use that is the customer used on the non-soft tissue, and it is determined to be use related issue, therefore a labeling review was performed.A review of the bard truguide disposable coaxial biopsy needle instructions for use (ifu ¿ baw1280500, rev.5) determined the product labeling documentation is adequate.G3, h6 (device, method, result, conclusion).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.

• 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: 23023585
• Report Number: 2020394-2025-01468
• Device Sequence Number: 9701593
• Product Code: FCG
• UDI-Device Identifier: 00801741085109
• UDI-Public: (01)00801741085109(11)241206(17)270930(10)REJX1738
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 Catalogue Number: C2016A
• Device Lot Number: REJX1738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male