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

Catalog Number	C2016A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2027).H11: 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.
Event or Problem Description
It was reported that during a computed tomography guided lung biopsy procedure through normal density tissue, the stylet part of the needle allegedly broke off inside the patient's body.Reportedly, the broken fragments of the device were removed from the patient.There was no reported patient injury.
Event or Problem Description
It was reported that during a computed tomography guided lung biopsy procedure through normal density tissue, the stylet part of the needle allegedly broke off inside the patient's body.Reportedly, the broken fragments of the device were removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 electronic photo was provided and reviewed.The photo shows one truguide coaxial cannula in two segments placed on the table.A complete circumferential break was noted to the cannula.Based on the photo review the reported break can be confirmed.One truguide coaxial cannula in two segments was received for evaluation.Upon visual evaluation, the coaxial received with protective tubing and appeared to have blood residue throughout.A complete circumferential break was noted to the cannula.Due to the nature of the complaint, functional testing was not performed.Therefore, the investigation is confirmed for the reported break as a complete circumferential break was noted to the cannula.A definitive root cause for the alleged break could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2027), g3 h11: d4 (unique identifier (udi) #), h6 (method, result, conclusion) 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.

• 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: 19747154
• Report Number: 2020394-2024-01034
• Device Sequence Number: 15086157
• Product Code: FCG
• UDI-Device Identifier: 00801741085109
• UDI-Public: (01)00801741085109(17)270131(10)REJP1190
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: C2016A
• Device Lot Number: REJP1190
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/15/2024
• 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