MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/BURRHOLE RESERVOIR; HYDROCEPHALUS VALVES

Model Number	FX468T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: optical inspection: first step of our investigation is the optical inspection.The optical examination showed bloody deposits on the catheter, see picture 2.At the microscopic investigation does not show any abnormalities on the distal end that catheter.Permeability test: an adjustment test is not necessary.Adjustment test: an adjustment test is not necessary.Braking force and brake function test: a braking force and brake function test is not necessary.Result: in the first step of our examination we performed an optical test of the catheter.No visual abnormalities could be found in the optical control except was blood on the catheter.In the course of our investigation, we have tried to investigate why the mandrin has not dissolved from the catheter.As seen in picture 3 to 7, we could solve the mandrin without any difficulties.On the membrane, strong deposits of blood could be detected at the distal end.Unfortunately, it is not possible to deduce, why there have been difficulties during the operation.However we can confirm that the manufacturing of the shuntsystem and the in-process controls guarantees the integrity of the product.All products are 100% performance tested and visually inspected during assembling, packaging and before final packaging.The valve was sterilized by miethke and released for shipment and documented as well.Based on our investigation results we could not detect any failure with this shunt system at the time of delivery.
Event or Problem Description
It was reported that there was an issue with progav 2.0 sys ped.W/burrhole reservoir (#fx468t).According to the complainant, during the insertion of vp shunt procedure, the distal end of the ventricular catheter included with the set was stuck to the stylet.The surgeon implanted the catheter into the ventricle, but, when he attempted to remove the stylet, it would not come out.The surgeon removed the catheter, with the stylet in side.With the catheter removed from the patient, the doctor tugged on the stylet, and it crimped the catheter.The surgeon selected to use another ventricular catheter than the one that was provided with the set.There was an surgical delay of 5-10 minutes.The catheter was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: optical inspection: first step of our investigation is the optical inspection.The optical examination showed bloody deposits on the catheter, see picture 2.At the microscopic investigation does not show any abnormalities on the distal end that catheter.Permeability test: an adjustment test is not necessary.Adjustment test: an adjustment test is not necessary.Braking force and brake function test: a braking force and brake function test is not necessary.Result: in the first step of our examination we performed an optical test of the catheter.No visual abnormalities could be found in the optical control except was blood on the catheter.In the course of our investigation, we have tried to investigate why the mandrin has not dissolved from the catheter.As seen in picture 3 to 7, we could solve the mandrin without any difficulties.On the membrane, strong deposits of blood could be detected at the distal end.Unfortunately, it is not possible to deduce, why there have been difficulties during the operation.However we can confirm that the manufacturing of the shuntsystem and the in-process controls guarantees the integrity of the product.All products are 100% performance tested and visually inspected during assembling, packaging and before final packaging.The valve was sterilized by miethke and released for shipment and documented as well.Based on our investigation results we could not detect any failure with this shunt system at the time of delivery.
Event or Problem Description
It was reported that there was an issue with progav 2.0 sys ped.W/burrhole reservoir (#fx468t).According to the complainant, during the insertion of vp shunt procedure, the distal end of the ventricular catheter included with the set was stuck to the stylet.The surgeon implanted the catheter into the ventricle, but, when he attempted to remove the stylet, it would not come out.The surgeon removed the catheter, with the stylet in side.With the catheter removed from the patient, the doctor tugged on the stylet, and it crimped the catheter.The surgeon selected to use another ventricular catheter than the one that was provided with the set.There was an surgical delay of 5-10 minutes.The catheter was returned to the manufacturer for evaluation.

• Brand Name: PROGAV 2.0 SYS PED.W/BURRHOLE RESERVOIR
• Common Device Name: HYDROCEPHALUS VALVES
• 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: 12953512
• Report Number: 3004721439-2021-00791
• Device Sequence Number: 14631503
• Product Code: JXG
• UDI-Device Identifier: 04041906138134
• UDI-Public: 4041906138134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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 Expiration Date: 12/31/2020
• Device Model Number: FX468T
• Device Catalogue Number: FX468T
• Device Lot Number: 20029389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2016
• 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