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 Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that a progav shuntsystem (#fv434-t) was implanted during a procedure performed on (b)(6) 2023.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device could not returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 4 years weight: 12.7 kg height: 105 cm gender: male.

Manufacturer Narrative

Due to the limited information and the missing product investigation is restricted to traceability of manufacturing and quality control data.Conclusion information: an investigation was not possible, because no product could return for investigation.Based on the product documentation, we can exclude a defect at the time of delivery of the progav shunt system, the traceability indicates that the shunt system was in perfect condition.The submitted pictures showed some bloody deposits in the reservoir.These may have affected the functions in the shunt system.Regarding similar complaints where mitehke could examine the products, it could determine that the most frequent cause for a deterioration in the function of the product are deposits caused by natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles.These are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valves if aggregated in the valves.A final clarification of the cause what has led to overdrainage and adjustment difficulties are only possible by an examination.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• 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, 14469 ; GM 14469
• MDR Report Key: 18345303
• MDR Text Key: 330726224
• Report Number: 3004721439-2023-00382
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906130862
• UDI-Public: 4041906130862
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2023

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: 12/09/2022
• Device Model Number: FV434-T
• Device Catalogue Number: FV434-T
• Device Lot Number: 20062701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 13 KG