MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W.SA30 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX436T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Incontinence (1928); Meningitis (2389); Hydrocephalus (3272); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A reassessment of vigilance was carried out on (b)(6) 2023 based on the newly submitted information.Assessment of the production site: investigation still ongoing.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx436t) was implanted during a procedure performed on (b)(6) 2023.The patient reported that the skull is swelling on back of the head.The following symptoms were reported: cranial hypertension, negative pressure on the sides, swelling, blurred monocular vision at a very high level, slurred speech, inbalance when walking, urinary incontinence and loss of recent memory.Headache.Some medication maneuvers were performed to alleviate the symptoms.The surgery was performed on (b)(6)2023 and a bent of the catheter and touching the bladder was determined.Patient data: age: 31 years height: 182 cm weight: 118 kg gender: male.
Additional Manufacturer Narrative
Conclusion information: based on the submitted manufacturing batch information we have double checked the traceability of the manufacturing and verifications done before shipment.The batch consist of two shunts.The testing of product specifications prior to packaging and the sterilization protocol revealed no deviations.On the provided photos, it is to see that the reservoir is not connect to the ventricular catheter.The disconnectivity would probably explain the presence of hygroma at the patient's head.The x-rays, showed the bent of abdominal catheter.This kind of bent can caused a blockage of the shunt.No further actions are required as a result of the complaint.

• Brand Name: PROGAV 2.0 SYS W.SA30 A.CONTROL RESERVOIR
• 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: 18371733
• Report Number: 3004721439-2023-00399
• Device Sequence Number: 12693390
• Product Code: JXG
• UDI-Device Identifier: 04041906137342
• UDI-Public: 4041906137342
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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: FX436T
• Device Catalogue Number: FX436T
• Device Lot Number: 20061222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 118 KG