MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	07/27/2024
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
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2024-00258.A physician reported a hakim valve (id 823162) was implanted due to normal pressure hydrocephalus (nph) via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The valve was used along with the ventricular catheter (id 823073) and peritoneal catheter (id 823074).The patient is a 3.5 year-old male, and the valve and catheters were implanted when the patient was 5 months old.On (b)(6) 2024, the consciousness level of the patient had declined and was vomiting.A slit-like ventricle was observed on x-ray, and ct scan showed that the ventricular catheter (id 823073) had fallen off.A revision surgery was performed, the valve and the ventricular catheter were explanted and replaced with a new device on (b)(6) 2024 except for the peritoneal catheter.There is no issue with the peritoneal catheter.The patient recovered.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The ventricular catheter (id (b)(6)) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.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 inadequate design choice (material/shape/connection).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: 20081531
• Report Number: 3013886523-2024-00259
• Device Sequence Number: 15343822
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: 10381780515623
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/14/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 03/14/2025
• 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: HAKIM VALVE (ID 823162).; PERITONEAL CATHETER (ID 823074).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male