MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SET PED.W/BURRH.RESERV.MININAV 5; HYDROCEPHALUS MANAGEMENT

Model Number	FV728T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
It was reported that a prosa (#fv728t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was believed to be operated in underdrainage and is difficult to adjust.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: 144 cm, weight: (b)(6), gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.The prosa valve housing was subsequently measured and indicated the presence of a slightly deformation.The housing deformation measured at -0.0325 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the prosa valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve is not operating within the acceptable tolerance in the vertical position.The valve showed an accelerated outflow.Results: first, we performed a visual inspection of the valve.No abnormalities were observed through the visual investigation.A deformation was detected through the measurement of the plan parallelism.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The opening pressure of the valve was out of tolerance, but all other specifications were met.An accelerated outflow was showed at the time of measuring.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).We would like to point out that the clinic has already performed the permeability test after the revision.Based on the results of our examination, we can detect an accelerated outflow at the valve.This is 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 hc-therapy by shunt implants.The cause of the deformation of the prosa valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the prosa 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: PROSA SET PED.W/BURRH.RESERV.MININAV 5
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11864113
• Report Number: 3004721439-2021-00140
• Device Sequence Number: 2990121
• Product Code: JXG
• UDI-Device Identifier: 04041906133825
• UDI-Public: 4041906133825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 12/01/2019
• Device Model Number: FV728T
• Device Catalogue Number: FV728T
• Device Lot Number: 20025550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 60