MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PAED.M.SA 20 U.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV441T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav valve (part # fv441t) was implanted during a procedure performed on (b)(6) 2014.According to the complainant, the valve spontaneously adjusted.The patient underwent a revision procedure on (b)(6) 2021.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), height: 130 centimeters (cm), weight: (b)(6) kilograms (kg), gender: unknown.
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® was manufactured by a qualified employee in may 2013.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 fv411t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the progav® was tested and is not adjustable throughout the normal range.Klick force and brake function test: the brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.Internal inspection: after dismantling of the valve, slightly deposits were found in progav® result: based on our investigation, we confirm that the was non-adjustable at the time of our investigation.The resultant defect of the rotor could not be determined through our investigation.Significant outside pressure, for example by too much force from the progav® adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV SYS PAED.M.SA 20 U.PRECHAMBER
• 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: 12823987
• Report Number: 3004721439-2021-00307
• Device Sequence Number: 4265169
• Product Code: JXG
• UDI-Device Identifier: 04041906132545
• UDI-Public: 4041906132545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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 Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 20020142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2013
• 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: 10 YR
• Patient Sex: Unknown
• Patient Weight: 25 KG