MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG UNIGAV SYSTEM WITH PRECHAMBER; HYDROCEPHALUS VALVES

Model Number FV555-T

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

Patient Problems No Patient Involvement (2645); Hydrocephalus (3272)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported device not marketed in the u.S.; however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Date of event: unknown.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional that "after opening the outer package the outlet part of the reservoir was detached.The device was not used 'in' the patient.".

Manufacturer Narrative

This report is being submitted retrospectively per fda request.Manufacturing site investigation: the unigav valve with prechamber was received dry.The outer package was opened and heavily soiled.The visual inspection noted that the catheter and the anchor that assist in the connection between the catheter and the intake spout of the prechamber were separated from the prechamber.The housing, which clamps the anchor and catheter to the prechamber, was still attached to the prechamber and showed remains of the catheter inside the spout.The catheter end was also observed to be non-uniform indicating a breakage or tear.A visual inspection was performed of the connection between the catheter and the prechamber connector.Under microscopic inspection the catheter end was shown to be wavy and the prechamber connector had remains from the catheter inside the end of the spout.During the manufacturing process, the catheter is connected to the prechamber via an anchor inserted into the end of the catheter.This is then inserted into the intake spout of the prechamber and pressed into place using a metal housing ring.This connection is intended to be permanent and great force is required to remove the catheter from the connector.The findings indicate that the catheter was pulled with force from the connector causing the defect.It is unclear through our investigation how it occurred.The product met all specifications of the final inspection during the manufacturing process.

• Brand Name: UNIGAV SYSTEM WITH PRECHAMBER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam,, MO 14469 ; GM 14469 ; 3145515988
• MDR Report Key: 8080321
• MDR Text Key: 128911124
• Report Number: 3004721439-2018-00266
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2022
• Device Model Number: FV555-T
• Device Catalogue Number: FV555-T
• Device Lot Number: 20034667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/05/2018
• Device Age: 1 YR
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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