MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX421T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: the valve was manufactured by a qualified employee in june 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a normal pressure range of 0-20 cmh2o.The valve was inspected; all parameters have been inspected and approved during the manufacturing process.All parameters had been assessed as meeting specifications.Statement: on the basis of juristic requirements we have to get the personal request by the surgeon as a step of safeguard.Unfortunately, we did not receive a consent.An official release is missing for the investigation of the product.For this reason, we returned the product for our discharge without examination.Result: 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 are required.
Event or Problem Description
According to the complainant a progav was suspected of blockage postoperatively.The patient was originally implanted on (b)(6) 2017e.The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.Further details were not provided.Height: 63 cm.

• Brand Name: PROGAV 2.0 WITH SA25 AND DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12656493
• Report Number: 3004721439-2021-00702
• Device Sequence Number: 4480844
• Product Code: JXG
• UDI-Device Identifier: 04041906136635
• UDI-Public: 4041906136635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: FX421T
• Device Catalogue Number: FX421T
• Device Lot Number: 20031303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 10/19/2021
• 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
• Patient Weight: 5