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

Model Number	C2016A
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer; however photos were provided and a photo review will be performed.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.The investigation of the reported event is currently underway the information provided by bard 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 bard.
Event or Problem Description
It was reported that during a biopsy, needle of the introducer broke off and migrated into the patient's abdomen.It was further reported that surgical intervention was performed to remove the needle.Post surgery, the patient's condition was stable.
Event or Problem Description
It was reported that during a biopsy, the coaxial introducer fractured inside the patient.It was further reported that the fragment was removed through the patient's abdomen via surgical intervention.Post surgery, the patient's condition was stable.
Additional Manufacturer Narrative
The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.One truguide coaxial and one electronic photo were returned for review.Based on the photo review and sample evaluation, a clear break can be noted approximately 1cm from the hub.Two coaxial segments were returned with the detached/broken segment of the cannula measuring approximately 10.5cm.The detached/broken segment of the cannula was also noted to be bent.Therefore, the investigation is confirmed for detachment of device or device component and cannula needle bend.The definitive root cause could not be determined based upon available information.It is possible that patient and/or procedural factors contributed to the reported event.A review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.(expiry date: 01/2021).(b)(4).

• Brand Name: BARD TRUGUIDE DISPOSABLE COAXIAL BIOPSY NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7648894
• Report Number: 2020394-2018-01018
• Device Sequence Number: 13689384
• Product Code: FCG
• UDI-Device Identifier: 00801741085109
• UDI-Public: (01)00801741085109
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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 Model Number: C2016A
• Device Catalogue Number: C2016A
• Device Lot Number: RECP1998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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