MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV SYSTEM W.PRECHAMBER 10/40; HYDROCEPHALUS MANAGEMENT

Model Number	FV332T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition).The prechamber with burrhole deflector was received in a plastic container inserted in an unknown liquid.Results: first we performed a visual inspection with the prechamber.The investigation revealed that it had no deformations or other abnormalities.However, inspection with a microscope showed likely salty deposits on the membrane.To see if the pump reservoir functioned properly we carried out a test.The results showed that it was easy to fill the reservoir without any delay.Because blockage was suspected, we tried to pump the test fluid out of the reservoir.The fluid was drained without difficulty.Based on our investigation results, we could not confirm that the prechamber with catheter was occluded.There was no failure detectable with this prechamber with catheter at the time of manufacture or delivery.No further actions required.
Event or Problem Description
According to the complainant a gav system was blocked postoperatively.The valve was implanted on an unspecified date.It was revised on (b)(6) 2017 and was returned to the manufacturer.Further details were not provided.

• Brand Name: GAV SYSTEM W.PRECHAMBER 10/40
• 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: 13029031
• Report Number: 3004721439-2021-00846
• Device Sequence Number: 4180011
• Product Code: JXG
• UDI-Device Identifier: 04041906127206
• UDI-Public: 4041906127206
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: 10/27/2021
• Device Model Number: FV332T
• Device Catalogue Number: FV332T
• Device Lot Number: 20032247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2016
• 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: 11 YR
• Patient Sex: Female