MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS VALVES

Model Number FV441T

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported by the healthcare professional to the company sales representative " ventricular catheter is bent, not straight.".

Manufacturer Narrative

Manufacturing and quality control data: the progav component was manufactured in january 2018.There were no deviations during assembly.All parameters (opening pressure, reflux, tightness, adjustability, and break function) were inspected and signed during the manufacturing process.All parameters have been assesses as ok.Investigation: optical inspection: the optical investigation showed that the introduction stylet is bent.Furthermore, it can be seen that the deflector is no longer in the position as at the time of delivery.Result: the obtained ventricular catheter was sent to us in its original packaging and in an opened sterile bag of a progav valve.The deflector has already been adjusted.The real reason why introducing the stylet is bent cannot be clearly established, but the in-process manufacturing controls, guarantee the integrity of the product.All products are 100% performance tested and visually inspected during assembling, packaging and before final packaging.The shunt system was sterilized by miethke and released for shipment and documented as well.A potential mistake at the ventricular catheter would be detected and rejected from the lot.Based on our investigation results, we could not detect any failure with this product at the time of distribution.No capa is necessary.

• Brand Name: PROGAV SYS PED.W/SA 20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7783167
• MDR Text Key: 117148301
• Report Number: 3004721439-2018-00182
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2023
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 20036729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Distributor Facility Aware Date: 06/18/2018
• Device Age: 6 MO
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1