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

Model Number 2016MSK

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/08/2021

Event Type  Injury  

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 not been returned to the manufacturer for evaluation.However, photo and video were provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2022).

Event Description

It was reported that during a biopsy procedure, the coaxial needle broke inside the patient's lung.It was further reported that the patient was taken to surgical procedure for removal of the fragment.The patient status was unknown.

Manufacturer Narrative

H10: 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.Investigation summary: the compatible coaxial was returned in two segments, the mission instrument was not received for evaluation.Upon visual evaluation, the coaxial appeared to have blood residue throughout and circumferential break.Upon microscopic observation, the ends of the circumferential break were both were noted to elliptical in shape.Three electronic photos were reviewed.The first photo shows that the compatible coaxial needle is broken and separated from the device.The second photo shows the broken part of the compatible coaxial needle alone and the third photo shows the remaining part of the compatible coaxial needle.One video was reviewed.A video shows a laparoscopic attempt at removal of an object that resembles a biopsy needle.It is not clear exactly where this object is lodged, but lung tissue is visible as is a pulsating structure resembling an artery.The object appears to be successfully removed with endo-forceps.Therefore, based on the photo, video review and sample evaluation, the reported break can be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 10/2022).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 Description

It was reported that during a biopsy procedure, the coaxial needle broke inside the patient's lung.It was further reported that the patient was taken to surgical procedure for removal of the fragment.The patient status was unknown.

• Brand Name: MISSION 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 -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12566710
• MDR Text Key: 274435925
• Report Number: 2020394-2021-01828
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K171953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: HUDX2537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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 Outcome(s): Required Intervention