MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONTROLRESERVOIR W/DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV048T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition).The valve was returned via the returnkit.Summary: without a signed release from the surgeon, an evaluation was not possible.The device was returned to the reporter.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miehtke gmbh & co.Kg.No further actions required.
Event or Problem Description
According to the complainant a control reservoir would not flush.After attaching the control reservoir to the progav2 and 25 shunt assistant combo, the surgeon attempted to flush the device and was unsuccessful.After separating it, he tried again and it would not flush; it eventually flushed after repeated attempts but it took a while for the ball bearing to be moved.Thus it was not implanted and another reservoir was used instead.The event date was noted as (b)(6) 2017.There was no patient harm.Further details were not provided.

• Brand Name: CONTROLRESERVOIR W/DISTAL CATHETER
• 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: 12919408
• Report Number: 3004721439-2021-00767
• Device Sequence Number: 20119593
• Product Code: JXG
• UDI-Device Identifier: 04041906131470
• UDI-Public: 4041906131470
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FV048T
• Device Catalogue Number: FV048T
• Device Lot Number: 20023704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2014
• 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
• Patient Sex: Unknown