MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV770T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the prosa valve was observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,0835 mm the housing membrane is outside tolerance (0 ± 0.02 mm).In addition, the following was detected: deposits/tissue residues on the product.Bloody delivery fluid.Third-party catheter (closed on one side) and third-party product (spout on catheter).Permeability test: a permeability test has shown that both valves are permeable.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 valves are tested in both the horizontal as well as the vertical positions.The results show that the valves operated within the accepted tolerance in both positions.Adjustment test: both valves were tested and are adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the required braking force of the prosa was not within the specified tolerances.Internal inspection: after dismantling of the valves, slightly deposits were found in both valves results: we would like to point out to you in advance that the adjustment test and permeability test have already been performed after the revision on clinic part.Based on our investigation results, we can detect a deformation of the prosa housing and a reduced braking force of the rotor at the time of our investigation.We suspect the detected deformation to be responsible for the functional impairment of the adjustability.Excessive pressure from the adjustment pin or a blow to the patient's head may compromise the integrity of the valve.Deposits caused by substances naturally present in the csf, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of protein can compromise the integrity of the valve.The cause of the deformation of the prosa valve and the resultant defect of the rotor could not be determined through our investigation.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a prosa shuntsystem (part # fv770t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be operated in overdrainage and different to adjust.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: 186 cm.Weight: (b)(6).Gender: male.

• Brand Name: PROSA SYS W/ADJ.DP.UNIT A.CONTROL RES.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12619553
• Report Number: 3004721439-2021-00279
• Device Sequence Number: 1361394
• Product Code: JXG
• UDI-Device Identifier: 04041906135553
• UDI-Public: 4041906135553
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 06/30/2020
• Device Model Number: FV770T
• Device Catalogue Number: FV770T
• Device Lot Number: 20027232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/12/2021
• 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: 58 YR
• Patient Weight: 90