MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE; CHPV

Catalog Number 823164

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Cerebral Ventriculomeglia (2133)

Event Date 11/15/2023

Event Type  Injury  

Event Description

This is 1 of 2 reports linked to mfg report number 3013886523-2023-00415.A physician reported a hakim valve (id 823164) and a bactiseal catheter kit (id 823072) were implanted via ventriculoperitoneal shunt on (b)(6) 2023.The valve and catheter were removed and replaced on (b)(6) 2023 due to the underdrainage caused by blockage in brain ventricle.The patient experienced dilation of cerebral ventricles due to underdrainage.Patient's primary disease was brain tumor.

Manufacturer Narrative

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

Manufacturer Narrative

The hakim valve (id 823164) was returned for evaluation: device history record (dhr) - product code 82-3164 with lot 6855340, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 120 mmh2o.The valve was visually inspected; a debris biological was noted in the housing.The valve was hydrated.The catheter was irrigated; no occlusion noted.The valve passed the tests for programming, occlusion, leak, reflux and pressure.The valve was dried.Root cause analysis ¿ no root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.A possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve.

• Brand Name: PROG VALVE INLINE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18239826
• MDR Text Key: 329395389
• Report Number: 3013886523-2023-00414
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K041296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BACTISEAL CATHETER (ID 823072)
• Patient Age: 6 MO
• Patient Sex: Male