MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHLUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: due to the condition of the shunt system upon receipt we are unable to investigate it.We would like to point out that the returned product was not submerged in liquid at the time of receipt and it was contaminated with bloody tissue residues.Due to this fact, the device was classified at the highest risk level to our staff.For hygiene reasons, it was not possible for us to investigate the product.Testing of valves sent in dry is of limited value.The product characteristics may be influenced by dry residues of cerebrospinal fluid or blood.Here, a check is not possible because the csf and tissue residues have already dried up.In the future please be sure to send the products with lower contamination, but not sterilized, and submerged in liquid (recommendation: isotonic saline solution, see questionnaire) to our complaints department.We could 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).We will return the product without examination to the sender.From our point of view no further regulatory actions are required.
Event or Problem Description
It was reported that a progav shuntsystem (#fv435t) was implanted during a procedure performed on (b)(6) 2018.According to the complainant, the valve was believed to be operated in over-drainage and not further adjustable.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) years.Weight: (b)(6) kg.Height: 158 cm.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHLUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11753157
• Report Number: 3004721439-2021-00111
• Device Sequence Number: 17185680
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• 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: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 02/28/2023
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20037044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/30/2021
• 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 Age: 12 YR
• Patient Weight: 60