MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL CATHETER KIT

Catalog Number 823072

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

The bactiseal catheter (id 823072) 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 Description

This is 2 of 2 reports linked to mfg report number 3013886523-2024-00059.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.

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 Description

N/a.

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Type of Device: BACTISEAL CATHETER KIT
• 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: 18839708
• MDR Text Key: 336924232
• Report Number: 3013886523-2024-00060
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: (01)10381780515616(17)240731(10)7281894
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823072
• Device Lot Number: 7281894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: HAKIM VALVE (ID (B)(6))
• Patient Age: 3 MO
• Patient Sex: Male