MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PRECHAMBER PED.; HYDROCEPHALUS MANAGEMENT

Model Number	FV035T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a prechamber ped.(part # fv035t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the valve was not able to be adjusted.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Patient data: age: 8 months; weight: 5 kilograms (kg); height: 60 centimeters (cm); gender: male.Same event as medwatch-no.:3004721439-2022-00248.
Additional Manufacturer Narrative
Manufacturing and quality control data the pediatric prechamber was manufactured by a qualified employee on october 2021.Deviations during assembly did not occur.The product was finally tested as article fv035t and released for packaging and sterilization and was sterilized by miethke.All tested parameters were assessed according to specifications.Visual inspection the following observations were made during the visual inspection: - no abnormalities detected.Permeability test the test showed that the pediatric prechamber is permeable.Results based on our investigation results, we cannot determine that there was a malfunction in the reservoir at the time of 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 gmbh & co.Kg.

• Brand Name: PRECHAMBER PED.
• 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: 15297352
• Report Number: 3004721439-2022-00249
• Device Sequence Number: 20402351
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: FV035T
• Device Catalogue Number: FV035T
• Device Lot Number: 20055513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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: 8 MO
• Patient Sex: Male
• Patient Weight: 5 KG