MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 25; HYDROCEPHALUS MANAGEMENT

Model Number FV489T

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Height: 170 cm.Investigation: visual inspection: n/a.Permeability test: n/a.Adjustment test: n/a.Braking force and brake function test: n/a.Results: the shunt system was sent to us with very bloody residues and tissue remnants.Against this background, the progav shunt system was assessed at the highest risk level for us.We do not have the necessary resources to investigate such contaminated products.We cannot remove this buildup of this kind without risking personal health.Under these conditions, an examination is not possible.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).

Event Description

It was reported that a valve is blocked.The reporter indicated that a post operative valve is blocked.The device was explanted.Additional event details have not been provided.

• Brand Name: PROGAV SYS W/SA 25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9507823
• MDR Text Key: 188559707
• Report Number: 3004721439-2019-00305
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: FV489T
• Device Catalogue Number: FV489T
• Device Lot Number: 20036558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 70