MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA VALVE; HYDROCEPHALUS VALVES

Model Number FV701T

Device Problem Overcorrection (3006)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufacturing site evaluation: evaluation on-going.Implant date: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "the surgeon had a difficult time adjusting the prosa device.After the explant the surgeon was still unable to adjust the device.No patient injury was reported.No delay in surgery was reported.

Manufacturer Narrative

Investigation: we have only received the product data, article number fv770t and serial number (b)(4).The product itself is not available for an investigation.Nevertheless our traceability can prove that there were no deviations.The prosa has a nominal pressure range of 0 to 40 cmws.All parameters (opening pressure, reflux, tightness, adjustability and brake function) are inspected and signed during the manufacturing process.A more thorough investigation was not possible because no product was sent for investigation.However, we point out that it is important to position the adjustment tool centrally over the valve.Please keep in mind, that even if the adjustment tool is used correctly, it may be difficult to adjust the valve due to a postoperative swelling of the skin within the first few days.Also, as described in our literature, any deposits of protein or blood that may be present can also affect the functioning of the valve.We can not confirm the cause of the issue since no product was returned.

• Brand Name: PROSA VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 7916119
• MDR Text Key: 121988509
• Report Number: 3004721439-2018-00255
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20026780
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/24/2018
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention