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

Catalog Number	C2020A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: (b)(6)2024) 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 ct-guided biopsy procedure through normal density lesion, during aspiration when physician pulled back on syringe to aspirate the abscess, the hub allegedly broke off of the needle.It was further reported that the needle was retrieved with forceps.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 truguide coaxial cannula in two segments and a depth stop were received for evaluation.Upon visual evaluation, the truguide coaxial cannula appeared to have blood residue throughout.The proximal end of the detached cannula appeared to be compressed.It was noted that the cannula hub was broken.The proximal end of the cannula was noted to be flatten.A bend was noted on the proximal portion of the cannula.Three electronic photos were provided and reviewed.The 1st photo captures a broken piece of cannula hub.The 2nd photo shows a labeling information and verified with tw.The 3rd photo captures a bent and broken proximal end of the cannula.Therefore, based on the photo review the reported break issue and identified bent can be confirmed.Therefore, the investigation is confirmed for the reported break issue as the cannula hub was broken.And the investigation is confirmed for the identified bent issue as a bend was noted on the proximal portion of the cannula.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 results letter needs to be provided to the end user informing them of the investigation conclusions.A definitive root cause for the reported break issue and identified bent issue are determined to be use related.A definitive root cause for the 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 the truguide needle for aspiration purpose 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 determined the product labeling documentation is adequate.Per the bard truguide disposable coaxial biopsy needle instructions for use how supplied section, the coaxial biopsy needle guide is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.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 pelvic aspiration procedure through normal density tissue, when physician pulled back on syringe to aspirate the abscess, the hub was allegedly broken off from the needle.It was further reported that broken needle was removed by using forceps.There was no reported patient injury.
Event or Problem Description
It was reported that during a computed tomography guided pelvic aspiration procedure through normal density tissue, when physician pulled back on syringe to aspirate the abscess, the hub was allegedly broken off from the needle.It was further reported that broken needle was removed by using forceps.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 truguide coaxial cannula in two segments and a depth stop were received for evaluation.Upon visual evaluation, the truguide coaxial cannula appeared to have blood residue throughout.The proximal end of the detached cannula appeared to be compressed.It was noted that the cannula hub was broken.The proximal end of the cannula was noted to be flatten.A bend was noted on the proximal portion of the cannula.Three electronic photos were provided and reviewed.The 1st photo captures a broken piece of cannula hub.The 2nd photo shows a labeling information and verified with tw.The 3rd photo captures a bent and broken proximal end of the cannula.Therefore, based on the photo review the reported break issue and identified bent can be confirmed.Therefore, the investigation is confirmed for the reported break issue as the cannula hub was broken.And the investigation is confirmed for the identified bent issue as a bend was noted on the proximal portion of the cannula.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 results letter needs to be provided to the end user informing them of the investigation conclusions.A definitive root cause for the reported break issue and identified bent issue are determined to be use related.A definitive root cause for the 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 the truguide needle for aspiration purpose 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 determined the product labeling documentation is adequate.Per the bard truguide disposable coaxial biopsy needle instructions for use how supplied section, the coaxial biopsy needle guide is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.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: 19267002
• Report Number: 2020394-2024-00614
• Device Sequence Number: 6996788
• Product Code: FCG
• UDI-Device Identifier: 00801741085123
• UDI-Public: (01)00801741085123(17)240531(10)REFT0972
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 12/02/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: C2020A
• Device Lot Number: REFT0972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 12/02/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 09/27/2024; 12/05/2024
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 117 KG
• Patient Race: White