MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV WITH DISTAL CATHETER 9/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV274T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a paedigav had a malfunction preoperatively.The valve was scheduled for implantation on (b)(6) 2017; it was tested and found to be "defective".It was not implanted and was returned to the manufacturer.Further details were not provided.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition) the product was returned to us dry in a plastic container (not submersed as recommended).Results: it should be noted that the product was received dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First we performed a visual inspection.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability.The valve was shown to have a blockage.Then we carried out a computer controlled simulated flow test.Due to the non-permeability of the valve, a computer controlled test was not possible to further investigate over/under drainage.Finally we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we could not detect any deposits inside the valve.We assume that dried, invisible deposits may have impaired the function of the valve in the past.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition) the product was returned to us dry in a plastic container (not submersed as recommended).Results: it should be noted that the product was received dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First we performed a visual inspection.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability.The valve was shown to have a blockage.Then we carried out a computer controlled simulated flow test.Due to the non-permeability of the valve, a computer controlled test was not possible to further investigate over/under drainage.Finally we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we could not detect any deposits inside the valve.We assume that dried, invisible deposits may have impaired the function of the valve in the past.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a paedigav had a malfunction preoperatively.The valve was scheduled for implantation on (b)(6) 2017; it was tested and found to be "defective".It was not implanted and was returned to the manufacturer.Further details were not provided.

• Brand Name: PAEDIGAV WITH DISTAL CATHETER 9/24
• 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: 13022142
• Report Number: 3004721439-2021-00844
• Device Sequence Number: 4650714
• Product Code: JXG
• UDI-Device Identifier: 04041906115005
• UDI-Public: 4041906115005
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• 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): 12/16/2021

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 Expiration Date: 01/05/2022
• Device Model Number: FV274T
• Device Catalogue Number: FV274T
• Device Lot Number: 20032737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2017
• 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