MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV W RICKHAM UNITIZED

Catalog Number	823113
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	Cerebral Edema (4403)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported an 18-day male child patient who experienced csf leakage, shunt malfunction and catheter rupture during the use of chpv shunt (bactiseal catheter kit id 823072) for unknown indication.Not reported: patient medical history, concurrent condition, family history, past medication, concomitant and co-suspect medications, drug allergies.On (b)(6) 2024, a chpv shunt (id 823072) was implanted at an unknown frequency via an unknown route.On (b)(6) 2024, the patient was admitted with the complaint of fluid accumulation under the neck region.Surgeon has been suspicious about the cerebrospinal fluid leakage (csf) leakage from the shunt-catheter junction (shunt malfunction) and bactiseal catheter rupture after implantation (device breakage).At the time of the reporting, the outcome of the events csf leakage, shunt malfunction, device breakage was unknown.Pertinent lab data included: on an unknown date, x-ray shows malfunction.The action taken with chpv shunt (id 823072) was unknown.Reaction description as per reporter: causality for the events csf leakage, shunt malfunction, device breakage was not reported for chpv shunt (id 823072).The case seriousness was reported as serious (hospitalization) by the reporter.This case was assessed as serious due to other medically important condition, hospitalization.The causality for the events is considered not assessable due to limited information regarding outcome of the reported events, co-suspects, concomitant medication and relevant medical history.As per the company safety information, the reported events of cerebrospinal fluid leakage is labeled and shunt malfunction, device breakage is unlabeled.
Additional 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 or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal catheter (id 823072) was not returned for evaluation, but a photo was provided showing a possible defect in the catheter, but without the catheter this defect could not be confirmed.Device history record (dhr) - product code 82-3072 with lot 7282713, conformed to the specifications when released to stock.Root cause analysis - the possible root cause for the issue reported by the customer, could be due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu silicone has a low cut/tear resistance.If the sample or additional information is received, this complaint will be re-opened, and evaluated.
Additional Manufacturer Narrative
Product id updated: device history record (dhr) - review of the history device records was not possible as the lot number was unknown.Product code 823113.
Event or Problem Description
N/a.

• Brand Name: MICRO CHPV W RICKHAM UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19667923
• Report Number: 3013886523-2024-00193
• Device Sequence Number: 20562369
• Product Code: JXG
• UDI-Device Identifier: 10381780534501
• UDI-Public: 10381780534501
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 823113
• Device Lot Number: 7282713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/01/2024; 04/10/2025
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/22/2024; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHPV SHUNT.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 DA
• Patient Sex: Male