MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX442T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data: the progav® 2.0 was manufactured by a qualified employee in june 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx442t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve had a blockage.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function was fully operational and the braking force was within the given tolerances.Result: first, a visual inspection of the progav® was performed.No significant deformations or damage to the valve were detected during the visual inspection.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve was not permeable, but met all other specifications.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim that the valve was not adjustable was not able to be confirmed.The valve was able to be adjusted to all specified settings.However, it is possible that the deposits observed inside the valve could have caused the malfunction.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required.

Event Description

It was reported miethke that a progav 2.0 sys ped.W/sa25 a.Prechamber (part # fx442t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was not adjustable.The patient underwent a revision procedure on (b)(6) 2016.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Weight: (b)(6).Height: 100 centimeters (cm).Gender: unknown.

• Brand Name: PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER
• 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: 12558024
• MDR Text Key: 276849740
• Report Number: 3004721439-2021-00633
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137472
• UDI-Public: 4041906137472
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX442T
• Device Catalogue Number: FX442T
• Device Lot Number: 20026941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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: 55 MO
• Patient Weight: 14