MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number FX435T

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

Patient Problem Hydrocephalus (3272)

Event Date 08/10/2022

Event Type  Injury  

Event Description

It was reported that a progav 2.0 shuntsystem (part # fx410t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the patient got worse in (b)(6) 2022.In the x-ray was verified the valve rupture.The patient underwent a revision procedure on (b)(6) 2022.The complaint device has not yet been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information - a2, a3, d4 (serial #), d9 investigation: visual inspection: the following observations were made during the visual inspection: -loosed spout of the shuntassistant with the connected distal catheter -no visible damage to the valve or spout results: based on our investigation results, we can detect a loss of functionality of the product.The reason for the disconnection of the spout and the gravitational unit/ valve housing is the loose fit.Why the parts showed low contact is subject of further internal investigations in form of a capa.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.
• Type of Device: 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: 15374803
• MDR Text Key: 299454917
• Report Number: 3004721439-2022-00274
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137335
• UDI-Public: 4041906137335
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX435T
• Device Catalogue Number: FX435T
• Device Lot Number: 20050026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male