MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT

Model Number 1816MSK

Device Problems Bent (1059); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: 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.Investigation summary: one truguide coaxial with component stylet and one electronic video were provided for review.The mission biopsy needle part of the kit was not returned.A visual/microscopic inspection and dimensional evaluation of the returned sample was performed.The investigation is confirmed for break, as the coaxial was returned in two segments and the video review showed the coaxial broken while both segments were still attached to each other in a bent configuration.Therefore, the investigation is also confirmed for bent.No other anomalies were noted.Per the evaluation results, a bent coaxial was confirmed along with the reported break.While a definitive root cause could not be determined based upon available information, a bent coaxial likely contributed to the reported break.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: 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.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 Description

It was reported that during an ultrasound-guided liver biopsy, the coaxial allegedly broke inside the patient.It was further reported that the procedure was completed with another device.There was no reported patient injury.

• Brand Name: BARD MISSION DISPOSABLE CORE BIOPSY INSTRUMENT KIT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7474615
• MDR Text Key: 106956351
• Report Number: 2020394-2018-00517
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1816MSK
• Device Catalogue Number: 1816MSK
• Device Lot Number: HUCQ0535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR