MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH DISTAL CATHETER; HYDROCHEPHALUS MANAGEMENT

Model Number	FX417T
Medical Device Problem Codes	Complete Blockage (1094); Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing evaluation: investigation on-going.Should additional relevant information become available, a supplemental medwatch report will be provided.
Event or Problem Description
The complainant reported that a progav 2.0 with distal catheter (part # fx417t) and a sprung reservoir set w/distal catheter (part # fv046t) (ref.Associated mdr id 3004721439-2020-00185) were placed in a patient sometime in (b)(6) 2019.On (b)(6) 2020 the physician observed a device occlusion, but noted no problem with the valve or catheter as cerebrospinal fluid was drained when the surgeon removed the product.The physician stated that the tip of the abdominal cavity catheter was likely blocked in the abdomen.No known patient complications occurred as a result of this event.
Additional Manufacturer Narrative
No product available for investigation.Manufacturing and quality control data: the progav 2.0 was manufactured by a qualified employee in march 2019.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav 2.0 valve has a normal pressure range of 0 to 20 cmh2o.The valve was inspected as article fx417t.All parameters (opening pressure, reflux, leak-proof/integrity of housing, adjustability and brake function) have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Reason of complaint: "possible occlusion of the valve." result : an investigation was not possible because no product was sent for investigation.It is possible that protein deposits inside the valves affect the function of the progav 2.0 and have led to a blockage.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.However, we cannot finally clarify what influenced the blockage, this would be require an examination of the valve.Based on the current information, no further regulatory actions are required from our point of view.
Event or Problem Description
The information that the product is not available for investigation is reached to us on 10/06/2020.Associated medwatch #3004721439-2020-00185.

• Brand Name: PROGAV 2.0 WITH DISTAL CATHETER
• Common Device Name: HYDROCHEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10532289
• Report Number: 3004721439-2020-00184
• Device Sequence Number: 3575749
• Product Code: JXG
• UDI-Device Identifier: 04041906136598
• UDI-Public: 4041906136598
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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 Expiration Date: 03/27/2024
• Device Model Number: FX417T
• Device Catalogue Number: FX417T
• Device Lot Number: 20041336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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