MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/PRECHAMBER 9/29; HYDROCEPHALUS MANAGEMENT

Model Number	FV287T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/12/2016
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 paediav¿ was manufactured by a qualified employee in april 2004.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a fixed pressure of 9cmh20 in the horizontal and 29 cmh20 in the vertical position.The valve was inspected as article fv287t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received submersed in an unidentified liquid in the provided returnkit.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Result first, a visual inspection of the paedigav¿.No significant deformations or damage to the valve were detected during the visual inspection.A microscope was used to detect deposits on the catheter inside the connection.A build-up of a substance (likely protein) was observed inside the connection.The paedigav¿ was manufactured in april 2004.During the manufacturing process, the catheter was pressed into the connector.Although the complaint was confirmed, a root cause of the breakage was not able to be determined.However, it is possible that growth-related forces may have caused the catheter to break.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported miethke that a paedigav system w/prechamber 9/29 (part # fv287t) was implanted during a procedure performed on (b)(6) 2014.According to the complainant, the catheter ripped off at the connector.The patient underwent a revision procedure on (b)(6) 2016.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.(b)(6).Gender: unknown.

• Brand Name: PAEDIGAV SYSTEM W/PRECHAMBER 9/29
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12465325
• Report Number: 3004721439-2021-00644
• Device Sequence Number: 11073837
• Product Code: JXG
• UDI-Device Identifier: 04041906116309
• UDI-Public: 4041906116309
• 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: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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 Model Number: FV287T
• Device Catalogue Number: FV287T
• Device Lot Number: 20002483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 09/13/2021
• 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: 40