MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/PRECHAMBER 9/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV286T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data: the paedigav® was manufactured by a qualified employee in september 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The paedigav® has a fixed pressure of 9 cmh2o in the horizontal and 24 cmh20 in the vertical position.The valve was inspected as article fv286t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Device examination: the paedigav® was returned submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage were detected during the visual inspection.Permeability test: a permeability test has shown that the valve was permeable with difficulty.Computer controlled test: to investigate under-drainage, the opening pressure was measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results showed that the valve was operating within the accepted tolerance in the vertical, but not in the horizontal position.The valve indicated underdrainage as suspected.Result: first, a visual inspection of the paedigav® was performed.No significant deformations or damage to the valve were detected during the visual inspection.Next, the permeability of the valve was tested.The valve was found to be permeable with difficulty.A computer controlled simulated flow test was performed which revealed that the valve was not operating within the accepted tolerance in the horizontal position.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of under-drainage was able to be substantiated.This was likely due to the deposits observed inside the valve.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.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required.
Event or Problem Description
It was reported miethke that a paedigav system w/prechamber 9/24 (part # fv286t) was implanted during a procedure performed on (b)(6) 2017.According to the complainant, the valve was believed to be operating in under-drainage.The patient underwent a revision procedure on (b)(6) 2017.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), weight: (b)(6) kilograms (kg), height: 62 centimeters (cm) gender: unknown.

• Brand Name: PAEDIGAV SYSTEM W/PRECHAMBER 9/24
• 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: 12790955
• Report Number: 3004721439-2021-00740
• Device Sequence Number: 20107450
• Product Code: JXG
• UDI-Device Identifier: 04041906116200
• UDI-Public: 4041906116200
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 06/30/2021
• Device Model Number: FV286T
• Device Catalogue Number: FV286T
• Device Lot Number: 20031810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2016
• 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: 3 MO
• Patient Sex: Unknown
• Patient Weight: 6 KG