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

Model Number FV701T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Implant date: (b)(6) 2018 (day unknown). When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "6m po valve is not adjustable. Explanted. " all med watch submissions related to this patient are: 3004721439-2018-00274 , 3004721439-2018-00275 (this report).

Manufacturer Narrative

The valve was received submerged in an unidentified liquid in a plastic container. A deformation of the outer casing of the valve was observed through the visual in specification. The prosa valve housing was measured to confirm the presence of the deformation. The housing deformation measured at -0. 0825mm, outside the tolerance of -0. 02 +-0. 02mm. The permeability test showed that the valve is permeable. However, it drains slowly indicating a possible partial blockage. The valve was tested and is adjustable to all specified pressures. The braking functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances. We performed a visual inspection of the prosa valve. A deformation of the outer casing of the valve was observed through the visual inspection. The deformation was confirmed with a measurement of the pain parallelity. Next we performed a permeability and adjustability of the valve, as well as the brake functionality and brake force. The valve was permeable but drained slowly indicating a possible partial blockage the valve met all other specifications. Finally, we have dismantled the valve. Inside the prosa we have found a buildup of substance (likely protein). Based on our investigation, we are unable to substantiate the claim of non-adjustability. The valve operates within the specified tolerances. Therefore, it is possible that the deposits observed inside the valve could have caused the malfunction in the past. The cause of the deformation of the prosa valve could not be determined through our investigation. Significant outside pressure, for example by too much force from the prosa adjustment tool or by a fall or impact to the head of the patient, 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 inspections.

• Brand Name: PROSA VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8063788
• MDR Text Key: 126933168
• Report Number: 3004721439-2018-00275
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• 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: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20036639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 11/28/2018
• Device Age: 9 MO
• Event Location: No Information
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/13/2018 Patient Sequence Number: 1