MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PRG CYL INTEGRAT CONNECTOR; HYDROCEPHALUS

Catalog Number NS5034

Device Problem Infusion or Flow Problem (2964)

Patient Problems Vomiting (2144); Sleep Dysfunction (2517)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported a (b)(6)-year-old male patient presented with sleepiness and vomiting.Surgeon tried to change the valve flow and it was not possible.A revision surgery was necessary to explant the product and during inspection of the explanted valve, it was noticed that the ball of the valve was blocked.The valve was implanted in 2011.

Manufacturer Narrative

The valve was returned for evaluation: failure analysis - the valve was visually inspected, some debris were noted on the outside of the housing.The valve passed the tests for programming, occlusions, leaks, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer "valve could not be programmed" could be due to "biosubstances interfere with programming mechanism" but, at the time of investigation, no programming or occlusion issues were noted.

Event Description

N/a.

• Brand Name: PRG CYL INTEGRAT CONNECTOR
• Type of Device: HYDROCEPHALUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11900637
• MDR Text Key: 253147721
• Report Number: 3013886523-2021-00236
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K122118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NS5034
• Device Lot Number: 453526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 12 YR