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

Model Number	FV173T
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: visual inspection showed the following: solid cristalline particle in the prechamber.Torn catheter visible.External deposits.Permeability test: a permeability test has indicated that the valve has a blockage.Computer controlled test: the measurement with the miethke computer controlled test bench could not be performed due to the detected blockage in section 2.5 permeability test.Internal inspection : after dismantling of the valve, slightly deposits were found in the dsv.Results: in advance, we would like to point out that the product returned was not submerged in liquid at the time of delivery.Dry valves can only be tested to a limited extent.The product properties can be influenced by dry residues of cerebrospinal fluid or blood.Nevertheless, we tested the product.Based on our investigation results, we can determine a catheter rupture and blockage at the valve at the time of our investigation.Due to the fact that the valve has been implanted for a long time and the resulting children's natural body growth, we suspect a possible malfunction of the catheter system respectively a possible disconnection/tearing of the catheter occurred.Without the associated catheter, we are unable to perform further analysis on disconnection.We suspect that the deposits detected within the valve and prechamber may have led to the functional impairment.Deposits caused by substances naturally present in the csf, such as protein, blood, or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of protein can compromise the integrity of the valve.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.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a dsv with a prechamber(part # fv173t) was implanted during a procedure performed in 2006.According to the complainant, the catheter between the prechamber and the reservoir was disconnected/ruptured.The patient underwent a revision procedure on (b)(6) 2021.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: 175 centimeters (cm).Weight: (b)(6).Gender: male.

• Brand Name: DSV SYSTEM W/PRECHAMBER 10/40
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12580133
• Report Number: 3004721439-2021-00269
• Device Sequence Number: 17016225
• Product Code: JXG
• UDI-Device Identifier: 04041906108304
• UDI-Public: 4041906108304
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 10/05/2021

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: FV173T
• Device Catalogue Number: FV173T
• Device Lot Number: 20004598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/05/2021
• 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: 28 YR
• Patient Weight: 75