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

Catalog Number	C1816A
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a lung biopsy procedure, the needle was allegedly not being inserted smoothly and the needle was allegedly being bent, resulting in sampling failure.It was further reported that there were also adverse events of injury, such as postoperative chest catheter drainage and massive pneumothorax, which were reported to the responsible department for key monitoring after discovery.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records was 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.H10: d4 (expiration date: 07/2025).H11: 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.H3 other text : device not returned.

• Brand Name: TRUGUIDE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 17823963
• Report Number: 2020394-2023-00747
• Device Sequence Number: 19443058
• Product Code: FCG
• UDI-Device Identifier: 00801741085031
• UDI-Public: (01)00801741085031
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: C1816A
• Device Lot Number: REGV3661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male