MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SPECIAL DEVICE UNITIZED PROGRA; CHPV WITH SG

Catalog Number NS9008

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2023

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 physician reported a hakim valve (id (b)(6) was implanted 8 years ago with unknown setting via lumbar peritoneal (lp) shunt.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).Image inspection confirmed that the lumbar catheter has come off from the connector.On (b)(6) 2023, the valve and catheter system were removed and replaced.The condition of the valve seems fine with no signs of debris.According to the information provided, it is unknown if patient had symptoms however, the patient was not feeling well.

Manufacturer Narrative

Hakim valve (id ns9008) was returned for evaluation.Device history record (dhr) - the product code ns9008 with lot ctfbyc, conformed to the specifications when released to stock.Failure analysis - -the valve was visually inspected, no defects were noted with the unitized peritoneal catheter returned with the valve.No connector was returned for investigation.No defects reported on the valve.The valve is a unitized valve, the catheter that was disconnected is not an integra device as noted.The valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).Root cause analysis - it was not possible to investigate the ¿image inspection confirmed that the lumbar catheter has come off from the connector.¿ issue reported by the customer as no connector was returned for investigation and the valve was used with the silascon® lumbar catheter (manufactured by kaneka, product code: 702-jj).(not an integra device).A possible root cause for the issue reported by the customer could be due the use of device that is not compatible with the integra device as noted in the ifu ¿use only with components compatible with the dimensions shown in the device description section.

Event Description

N/a.

• Brand Name: SPECIAL DEVICE UNITIZED PROGRA
• Type of Device: CHPV WITH SG
• 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: 18231814
• MDR Text Key: 329315512
• Report Number: 3013886523-2023-00404
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10886704073161
• UDI-Public: (01)10886704073161(17)200331(10)CTFBYC
• Combination Product (y/n): N
• PMA/PMN Number: K221840
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: NS9008
• Device Lot Number: CTFBYC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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: 702-JJ SILASCON® LUMBAR CATHETER
• Patient Sex: Male