MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV UNITIZED

Catalog Number	823114
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hakim valve (id: 823114) was not returned for evaluation as the product was discarded; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint could be linked to the patient and hospital surroundings.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
This is 1 of 2 reports linked to mfg report number 3013886523-2024-00060.A facility reported a hakim valve (id: 823114 ) and catheter (id: 823072) were implanted on (b)(6) 2024.After 20 days, it was found that hydrocephalus was not obvious while the patient had intracranial infection under computerized tomography (ct) check.On (b)(6) 2024, the physician conducted a procedure and retrieved the valve and catheter.Patient is waiting for the revision procedure after the anti-infection therapy.According to information provided, the type of infection or organism is unknown.
Additional Manufacturer Narrative
Additional information received: "we are informed by the dealer that these two products were not implanted into the patient on (b)(6) 2024.On (b)(6) 2024, the physician was intended to implant micro chpv unitized (id (b)(6)) & codman bactiseal catheter kit (id (b)(6)) and they had already open the device.While during the procedure, the physician found there was biogenic deposit in patient¿s brain, they suspected that the patient had infection.Therefore, they stopped implanting the products.".
Event or Problem Description
N/a.

• Brand Name: MICRO CHPV UNITIZED
• Common Device Name: 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: 18839386
• Report Number: 3013886523-2024-00059
• Device Sequence Number: 7132990
• Product Code: JXG
• UDI-Device Identifier: 10886704041498
• UDI-Public: (01)10886704041498(17)240430(10)3838817
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 823114
• Device Lot Number: 3838817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2019
• 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: BACTISEAL CATHETER (ID (B)(6)).
• Patient Age: 3 MO
• Patient Sex: Male