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

Catalog Number	C1616A
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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 an ultrasound guide kidney biopsy procedure via normal density tissue using the coaxial.During the procedure, the device mismatched with the size of biopsy needle due to wrong labeling of coaxial needle.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.One electronic video was provided and reviewed.The operator initially removed the trocar stylet from the two introducer coaxial cannulas.He then attempted to insert the 16g maxcore biopsy device into the two 16g truguide introducer coaxial cannulas, designated with lot rejy0151 and catalogue c1616a.However, he encountered resistance and was unable to complete the insertion.Therefore based on the video review, the device-device incompatibility issue was identified for the two devices as the operator can't able to insert the maxcore into the truguide and the reported issue is remains inconclusive for both the devices as no objective evidence was provided to support the reported event.A definitive root cause for the reported device markings / labelling problem issue and identified device-device incompatibility issue could not be determined based upon the provided information.Labeling review: by comparing the received pouch label from the video provided from the customer against document "(b)(4)" (rev.3), it was noted that the catalogue number, pk number, gauge size & needle length, lot number characters, use by date format which was mentioned in the pouch was verified and it matched with the document.And it also matches with the tw information.D4 (unique identifier (udi) #), g3, h6 (device, component, method, result, conclusion) section a through f ¿ the information provided 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 an ultrasound guide kidney biopsy procedure via normal density tissue using the coaxial.During the procedure, the device mismatched with the size of biopsy needle due to wrong labeling of coaxial needle.The procedure was completed using another device.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: 23120427
• Report Number: 2020394-2025-01549
• Device Sequence Number: 7393853
• Product Code: FCG
• UDI-Device Identifier: 00801741084966
• UDI-Public: (01)00801741084966(11)250107(17)271031(10)REJY0151
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: C1616A
• Device Lot Number: REJY0151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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