MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2024-00405.3013886523-2024-00407.A facility reported that a patient was sent to the hospital due to hydrocephalus, coma, grade iii hypertension, pneumonia, and sequelae of cerebral hemorrhage.On (b)(6) 2024, a hakim valve (id 823832), a bactiseal ventricular catheter (id 823073), and a bactiseal peritoneal catheter (id 823074) were implanted.On (b)(6) 2024, the patient¿s hydrocephalus did not improve, and the valve pressure was adjusted eight times; however, the pressure could not be adjusted.On (b)(6) 2024, the physician implanted a new valve and two catheters into the patient's right cerebral ventricle.Due to the patient's condition, the physician left the valve in the patient.There is no plan to remove the valve.According to information provided, it is unknown if there is an issue or a failure with the two catheters and if the patient experienced any signs and symptoms due to the devices issue.The current status of the patient is unknown.
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 ventricular catheter (id 823073) was not returned for evaluation as the product was implanted 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, however, a possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.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
N/a.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Common Device Name: BACTISEAL VENTRICULAR CATHETER
• 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: 21093309
• Report Number: 3013886523-2024-00406
• Device Sequence Number: 13054315
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)250131(10)7358063
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 01/31/2025
• Device Catalogue Number: 823073
• Device Lot Number: 7358063
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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 PERITONEAL CATHETER (ID 823074).; HAKIM VALVE (ID 823832).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian