MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Cerebral Ventriculomegaly (2133)
Date of Event	02/15/2025
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
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2025-00051.A physician reported a certas valve (id 828814), bactiseal ventricular catheter (id 823073) and bactiseal peritoneal catheter (id 823074) were implanted due to secondary normal pressure hydrocephalus (snph) and brain tumor, via ventriculoperitoneal (vp) shunt on (b)(6) 2025 with setting 3.After the surgery, the ventricle shrunk, and the condition had improved.On (b)(6) 2025, the patient developed ventricular dilatation again and suffered from a headache.The pressure setting was changed from 3 to 1, but there was no sign of improvement.Therefore, the shunt and catheter were removed on (b)(6) 2025, and the patient is on external drainage.Obstruction was suspected on the catheter.They are planning to implant a new device via vp shunt.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: c1, d4, d9, g3, ,g4, g6, h2, h3, h4, h6, h11.The certas valve (id 828814) was returned for evaluation.Device history record (dhr) - the product code 823072 with lot 7466988 sn:n/a conformed to the specifications when released to stock.Failure analysis - the catheter was visually inspected and no defects noted.The catheter was irrigated and no occlusions noted.The catheter was leak tested and no leaks were noted.The complaint was unconfirmed.Root cause analysis - no root cause for the issue reported by the customer could be determined as no defects could be found with the catheter.A possible root cause for the issue reported by the customer, could be due to catheter susceptible to kinking which could lead to an occlusion.As seen in the investigation no occlusion was found with the catheter.

• 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: 21546838
• Report Number: 3013886523-2025-00050
• Device Sequence Number: 12546197
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)250930(10)7466988
• Combination Product (Y/N): N
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 09/30/2025
• Device Catalogue Number: 823073
• Device Lot Number: 7466988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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: CERTAS VALVE (ID 828814).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Female