MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 10; HYDROCEPHALUS MANAGEMENT

Model Number FX640T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection: during the investigation, no significant deformations or damage of the valve were determined but signs of the adjustment tool on the plastic bag could be determined.Permeability test: not applicable, due to the sterile packaging computer controlled test: not applicable, due to the sterile packaging adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected but the braking force measurement is not applicable, due to the sterile packaging.Internal inspection: the internal inspection ist noch necessary results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.We can exclude a defect at the time of release.The shunt system 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 Description

It was reported that a progav 2.0 shunt system (#fx640t) was not adjustable preoperatively in the sterile packaging.The complainant's device was returned to the manufacturer for evaluation.No patient was involved.

Manufacturer Narrative

Correction: b1 + e1 + h1.

Event Description

It was reported that a progav 2.0 shunt system (#fx640t) was not adjustable preoperatively in the sterile packaging.The complainant's device was returned to the manufacturer for evaluation.No patient was involved.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 10
• 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: 18574543
• MDR Text Key: 333658166
• Report Number: 3004721439-2023-00402
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906501983
• UDI-Public: 4041906501983
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

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
• Device Operator: Health Professional
• Device Model Number: FX640T
• Device Catalogue Number: FX640T
• Device Lot Number: 20071018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• 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