MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV VALVE 9/29; HYDROCEPHALUS MANAGEMENT

Model Number	FV295T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to miethke that a paedigav valve (b)(6) (part # fv295t) was to be implanted during a procedure performed on (b)(6) 2017.According to the complainant, a blockage of the valve was observed.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: 99 centimeters (cm).Gender: unknown.
Additional Manufacturer Narrative
This complaint was reopened in reference to qab 2154.Manufacturing site evaluation: manufacturing and quality control data the paedigav 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 valve has a fixed pressure of 9 cmh20 in the horizontal position and 29 cmh20 in the vertical position.The valve was inspected as article fv295t.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 submerged in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Computer controlled test: to investigate the claim of over/under-drainage, the opening pressure was measured using a miethke computer controlled testing apparatus which simulates a cerobrospinal fluid flow.The results showed that the valve was not operating within the accepted tolerance in either position.In the horizontal position, the valve tends to underdrain; in the vertical position, to overdrain.Result: a visual inspection of the paedigav was performed.No significant deformations or damage to the valve were detected during the visual inspection.Next, the valve permeability was tested, which revealed that the valve was not penetrable.Next, a computer controlled simulated flow test was performed, the results showed that the valve was not operating within the accepted tolerance in either position.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the valve was found to be occluded.This was likely due to the deposits observed inside the valve.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 (b)(4).No further regulatory actions are required.

• Brand Name: PAEDIGAV VALVE 9/29
• Common Device Name: 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: 12964797
• Report Number: 3004721439-2021-00780
• Device Sequence Number: 19937343
• Product Code: JXG
• UDI-Device Identifier: 04041906114565
• UDI-Public: 4041906114565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: FV295T
• Device Catalogue Number: FV295T
• Device Lot Number: 20026988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Unknown
• Patient Weight: 17 KG