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

Model Number	FV320T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complainant a gav had a malfunction preoperatively.The valve was tested and found to be impermeable; the surgeon decided to use a different valve instead.The gav was not implanted but returned to the manufacturer.Further details were not provided.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition): the valve was received submersed in an unindented liquid via the provided returnkit.Result: first we performed a visual inspection of the valve.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability.The valve was shown to be permeable.It was noted that there was a hole in the catheter at the outlet side of the catheter, from which liquid has escaped.We cannot explain how a hole in a catheter occurred.While using sharp instruments, care should be taken to avoid cuts and scratches in the silicone elastomer.Strong bending of the catheter at the valve grommet can also affect the integrity of the product.All of our products go through a strict visual inspection during assembly, packaging, after sterilization, before final packaging and before release for sale.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miehtke gmbh & co.Kg.No further actions required.

• Brand Name: GAV W.DISTAL CATH.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: 12989483
• Report Number: 3004721439-2021-00819
• Device Sequence Number: 5262055
• Product Code: JXG
• UDI-Device Identifier: 04041906126001
• UDI-Public: 4041906126001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: FV320T
• Device Catalogue Number: FV320T
• Device Lot Number: 20033808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2017
• 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
• Patient Age: 1.5 YR
• Patient Sex: Unknown