MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FV434-T

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Patient Problem/Medical Problem (2688); Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

Visual inspection: a visual inspection based on the pictures shows clear traces of deposits in the reservoir.Further statements cannot be available without a submitted product.Permeability test: not practicable, because the product is not available.Adjustment test: not practicable, because the product is not available.Braking force and brake function test: not practicable, because the product is not available.Results: first, we would like to draw your attention to the fact that an investigation without a product is not possible and therefore not meaningful.In the treatment of hydrocephalus with shunts, the following complications may arise (as described in the literature)1: infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage or in very rare cases noise development.We assume that the deposits in the reservoir have led to the said blockage.Whether the progav and the shunt assistant are also affected by a blockage, cannot be determined without the product.What has actually led to infection/ blockage does not explain us, as this would require an investigation of the product.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from (b)(4).

Event Description

It was reported that on (b)(6) 2018, the patient underwent extra ventricular drainage for spontaneous intracerebral hemorrhage, and recovered smoothly.On (b)(6) 2019, the patient developed symptoms of retardation.A head ct showed hydrocephalus.A ventriculoperitoneal (vp) shunt was performed on (b)(6) 2019.The abdominal end was placed on the hepatic septum by laparoscopy, and the shunt valve was placed above the mastoid process.After repeated ct examination, the symptoms of hydrocephalus were not relieved significantly.Repeated pressing of the reservoir sac during the period was smooth.On (b)(6) 2019, it was found that the pressure elasticity of the shunt valve became worse, the patient's headache worsened, and the lumbar puncture test indicated the occurrence of infection.The ventriculoperitoneal (vp) shunt was removed on (b)(6) 2019.Floccules were found in the shunt, resulting in obstruction.The product has been taken out and discarded by the hospital, so there is no sample return.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• 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: 9145720
• MDR Text Key: 165627462
• Report Number: 3004721439-2019-00254
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K161853
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: FV434-T
• Device Catalogue Number: FV434-T
• Device Lot Number: 20040618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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