MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hydrocephalus (3272)
Date of Event	08/03/2024
Type of Reportable Event	Serious Injury
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
A facility reported a certas valve (id 828805), a ventricular catheter (id 823073) and a peritoneal catheter were implanted on (b)(6) 2024, with a valve setting at 1.Due to the growth of the cephalic perimeter, patient experienced weakness and drowsiness; therefore surgical intervention was required after implantation.During the procedure, the surgeon observed that the cerebrospinal fluid (csf) was flowing slowly and not in a sufficient volume through the peritoneal catheter.The ventricular catheter was cut, and a sufficient, ample, and clear csf drip was observed.The valve and ventricular catheter were removed and replaced on (b)(6) 2024.The peritoneal valve was not explanted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The ventricular catheter (id 823073) 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.There is no root cause possible as it was reported: "we understand that there are no complaints against the ventricular catheter because the flow was adequate".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.

• 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: 20086824
• Report Number: 3013886523-2024-00254
• Device Sequence Number: 12715291
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)240531(10)7250701
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 823073
• Device Lot Number: 7250701
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: CERTAS VALVE (ID 828805); PERITONEAL CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 MO
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic