MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Sleep Dysfunction (2517); Hydrocephalus (3272)
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 physician reported a bactiseal ventricular catheter (id 823073) was implanted due to hydrocephalus via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.At the age of 7, the patient was diagnosed with a brain tumor and hydrocephalus, and she underwent surgery to remove the tumor.The patient suffered from drowsiness and deglutition disorder.A magnetic resonance imaging (mri) confirmed the recurrence of hydrocephalus.The contrast radiography showed no apparent sign of obstruction though, the abdomen side of the device seemed to be having bad flow.A revision surgery was performed and confirmed no blockage in peritoneal catheter.Therefore, the ventricular catheter was removed and replaced on an unknown date.The placement of catheter was a little too deep which may have caused the shunt dysfunction.The family stated that, the patient bumped her head several times at home and was concerned that the device could be broken due to the accident.
Additional Manufacturer Narrative
The bactiseal ventricular catheter (id 823073) was returned for evaluation.Failure analysis - the catheter was visually inspected, 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 could be determined as the technician could not confirm any problem with the catheter at the time of investigation.The possible root cause for the issue reported by the customer, could be due to a kink in the catheter, or an issue with the valve.
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: 20864477
• Report Number: 3013886523-2024-00380
• Device Sequence Number: 21006139
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: 10381780515623
• Combination Product (Y/N): Y
• PMA/510(K) Number: K233445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/04/2025

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 Catalogue Number: 823073
• 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: 11/18/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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); CERTAS INLIN VLV ONLY W/SPHNGD (ID 828804)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Sex: Female