MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 U.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX352T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx352t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be operated in malfunction.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Associated medwatch report # 3004721439-2022-00014 and 3004721439-2022-00015.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information + result: an investigation was not possible because the product is not available.On (b)(6), 2022 the b.Braun aesculap japan co., ltd.Informed us, that the hospital destroyed the valve.The description of the reason: " this is an example of replacement because the valve was blocked.The cause of the obstruction is hematoma formation in the valve due to bleeding in the subcutaneous pocket during surgery.The surgeon tried to clean the valve, but the hematoma could not be removed, so he replaced it at a later date." * sales staff's comment: the sample has already been destroyed.The doctor do not recognize it as a mechanical trouble.For these reasons, no product survey is required.Based on the current information, no further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 WITH SA20 U.SPRUNG RESERVOIR
• Common Device Name: 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: 13502097
• Report Number: 3004721439-2022-00013
• Device Sequence Number: 17122421
• Product Code: JXG
• UDI-Device Identifier: 04041906140014
• UDI-Public: 04041906140014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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 Model Number: FX352T
• Device Catalogue Number: FX352T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown