MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX421T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: deposits on the catheter (possibly calcified) were detected, but no significant deformations or damage of the valves were detected during the visual inspection.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 both valves are not operating within the acceptable tolerance in either position.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking/klick 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.Internal inspection : after dismantling of the valves, some deposits were found in both valves.Results: based on our investigation results, we can identify a accelerated outflow in the shunt system.We are assuming that the deposits detected within the valve have caused the functional impairment.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.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 gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx421t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be operating in underdrainage and adjustment difficulties were experienced.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: unknown.Height: (b)(6) centimeters (cm).Weight: (b)(6) kilograms (kg).Gender: female.

• Brand Name: PROGAV 2.0 WITH SA25 AND DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12387759
• Report Number: 3004721439-2021-00247
• Device Sequence Number: 4724113
• Product Code: JXG
• UDI-Device Identifier: 04041906136635
• UDI-Public: 4041906136635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/30/2021

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: 05/16/2021
• Device Model Number: FX421T
• Device Catalogue Number: FX421T
• Device Lot Number: 20030301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/30/2021
• 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 Weight: 40