MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. TRUGUIDE COAXIAL BIOPSY NEEDLE; BIOPSY INSTRUMENT

Model Number	C1810A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during a ct-guided biopsy of a cirrhotic liver of normal density, the needle of the device allegedly broke off inside the patient after the procedure was completed.It was further reported that the needle was surgically removed from the patient.The patient is reportedly fine.
Event or Problem Description
It was reported that during a ct-guided biopsy of a cirrhotic liver of normal density, the needle of the device allegedly broke off inside the patient after the procedure was completed.It was further reported that the needle was surgically removed from the patient.The patient is reportedly fine.
Additional Manufacturer Narrative
Manufacturing review: the dhr has been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one truguide coaxial was returned.A visual inspection and dimensional evaluation was performed.The sample appeared to be soiled with residue.The device was returned in two pieces.The beak was noted between the hub and the coaxial needle.The coaxial piece measures approx.5.8cm from break to distal tip, which matches the expected coaxial length for catalog c1810a.No other anomalies were noted.Therefore, the investigation is confirmed as reported for detachment of device or device component, specifically a coaxial needle.The definitive root cause could not be determined based upon available information.It is unknown whether patient factors and/or procedural issues contributed to the reported event.Potential contributing factors include insufficient packaging (e.G.Damage to device), effect of sterilization or aging (e.G.Degradation), use error (e.G.Inappropriate handling, use of bent needle), insufficient securement of components, inappropriate interaction with biopsy needle; however, identification of a root cause(s) could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: TRUGUIDE COAXIAL BIOPSY NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 8578726
• Report Number: 2020394-2019-00540
• Device Sequence Number: 11172295
• Product Code: FCG
• UDI-Device Identifier: 00801741085000
• UDI-Public: (01)00801741085000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K936194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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 Expiration Date: 11/30/2020
• Device Model Number: C1810A
• Device Catalogue Number: C1810A
• Device Lot Number: RECZ1117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention