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

Catalog Number	823072
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Altered State of Consciousness (4589)
Date of Event	01/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2025-00137.Event from a post-market clinical program: a facility reported that a hakim valve (id 823832) and bactiseal catheter (id 823072) were implanted on (b)(6) 2021.The patient was admitted two months after undergoing surgery for a brainstem cavernous hemangioma.Comprehensive examinations were performed upon admission.On (b)(6) 2022, the patient presented with altered mental status and intermittent fever, suggesting retrograde intracranial infection secondary to abdominal infection.Due to recurrent symptoms, a vp shunt revision was performed on (b)(6) 2022, during which the abdominal end of the shunt catheter was externalized and connected to a drainage bag.Postoperative findings: cerebrospinal fluid (csf) smear revealed gram-positive cocci, prompting central nervous system (cns) antibiotic therapy.By (b)(6) 2022, the patient reported no significant discomfort and showed satisfactory recovery, leading to discharge on the same day.Subsequent admission (two months post-shunt): the patient was readmitted on (b)(6) 2022, with progressive consciousness disturbance over two days.An external head ct indicated supratentorial hydrocephalus, necessitating: burr hole drainage + vp shunt removal.Aggressive anti-infective and symptomatic treatment.Complications & further interventions: on (b)(6) 2022, acute worsening of hydrocephalus due to drainage tube obstruction required a repeat burr hole drainage + removal of the left external ventricular drain (evd).By postoperative day 2 ((b)(6) 2022), the patient developed weak spontaneous respiration and episodes of apnea, leading to: temporary tracheostomy.Mechanical ventilation dependence (failure to wean).Given the poor prognosis, the family opted for palliative care, and the patient was discharged on (b)(6) 2022.
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.
Additional Manufacturer Narrative
The bactiseal catheter (id 823072) was not returned for evaluation as the product is not available for return as per customer; 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.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.Additional information: the physician has changed the correlation decision of this event from ¿relevant¿ to ¿irrelevant¿, (not related to the bactiseal catheter-id 823072).

• Brand Name: CODMAN BACTISEAL CATHETER KIT
• Common Device Name: BACTISEAL CATHETER KIT
• 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: 22201647
• Report Number: 3013886523-2025-00138
• Device Sequence Number: 7644491
• Product Code: JXG
• UDI-Device Identifier: 10381780515616
• UDI-Public: (01)10381780515616(17)220331(10)5396167
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 823072
• Device Lot Number: 5396167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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: HAKIM VALVE (ID 823832).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian