MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE BRAINPRO BIOPSIEKANÜLEN SET; BRAINPRO CLASS III BIOPSY CANNULAE SET, PRODUCT CODE:HAW

Model Number 41779C

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still running.As soon as further information becomes available a follow up report will be sent in to the agency.The claimed brainpro biopsy needle from the set art.No.41779c that we have delivered to brainlab is for the brainlab complete system for brain biopsies in which our product is integrated and used by brainlab.We supply a class iii product to this system.The product code is therefore selected as haw and entered as such under part d / d2b.

Event Description

Irn# (b)(4).Biopsy needle skived off the tough exterior of the lesion leading to no diagnostic tissue being collected.Most likely due to anatomical structure deflects the needle away from the trajectory causing it to bend once the needle approaches the brainstem.

• Brand Name: BRAINPRO BIOPSIEKANÜLEN SET
• Type of Device: BRAINPRO CLASS III BIOPSY CANNULAE SET, PRODUCT CODE:HAW
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str.7; geisingen
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall str. 1; tuttlinger str. 7; tuttlinger str. 7 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen 78187 ; 0499291586
• MDR Report Key: 18718996
• MDR Text Key: 335537165
• Report Number: 9611612-2024-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41779C
• Device Catalogue Number: 41779C
• Device Lot Number: 1507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• 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
• Patient Sex: Female