MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV SYSTEM W.PRECHAMBER 5/35; PRO GAV

Model Number FV329T

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that the patient requires ventricle peritoneal derivation, the ventricular catheter with reservoir, easily it twist and generates system dysfunction.The catheter is crooked.

Manufacturer Narrative

The ventricular catheter was received in the original packaging.The sterile bag of the ventricular catheter was unopened.A visual inspection was performed and the catheter was curved.Based on investigation results, we could not detect any failure with the product.No further actions are required.

• Brand Name: GAV SYSTEM W.PRECHAMBER 5/35
• Type of Device: PRO GAV
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7710968
• MDR Text Key: 114729015
• Report Number: 3004721439-2018-00153
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2022
• Device Model Number: FV329T
• Device Catalogue Number: FV329T
• Device Lot Number: 20033746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Distributor Facility Aware Date: 06/18/2018
• Device Age: 1 YR
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other