MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG DUALSWITCH-VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FV100T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/24/2022
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 dualswitch-valve 10/30 (part # fv100t) was implanted during a procedure performed on (b)(6) 2002.According to the complainant, the abdominal catheter has ruptured.The patient underwent a revision procedure 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.Age: (b)(6).Height: 162.5 centimeters (cm).Weight: (b)(6) (kg).Gender: female.
Additional Manufacturer Narrative
Manufacturing and quality control data.The dsv was manufactured by a qualified employee on (b)(6) 2001.Deviations during assembly did not occur.The product was finally tested as article fv100t and released for packaging and sterilization and was sterilized by miethke.The dsv has a fixed pressure of 13 cmh2o in horizontal and 30 cmh2o in the vertical position.The parameters after completion of the valve assembly were tested at a flow rate of 50 ml/h at a fixed pressure of 13/ 30 cmh2o were found to meet specifications.All tested parameters were assessed according to specifications.Visual inspection: the following observations were made during the visual inspection: - missing catheter/ torn catheter visible - deposits on the valve permeability test: the test showed that the dsv is permeable, the liquid was bloody.Internal inspection of product: after dismantling of the valve, deposits were found in dsv.Results: based on our investigation results, we have determined a catheter rupture.Over almost 20 years of implantation the shear and tensile forces applied might have led to a rupture.The magnitude of these forces cannot be determined retrospectively.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: DUALSWITCH-VALVE 10/30
• 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: 14218247
• Report Number: 3004721439-2022-00115
• Device Sequence Number: 4124547
• Product Code: JXG
• UDI-Device Identifier: 04041906101008
• UDI-Public: 4041906101008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• 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): 05/03/2022

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: FV100T
• Device Catalogue Number: FV100T
• Device Lot Number: 20000257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 04/17/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2001
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 43 KG