MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2025-00082, 3013886523-2025-00084.A facility reported a hakim valve (id: 823832), a bactiseal ventricular catheter (id: 823073), and a bactiseal peritoneal catheter (id: 823074) were implanted on (b)(6) 2025.After the procedure, the patient was found to have subcutaneous hydrops.Therefore, the products were removed and replaced due to suspicion of occlusion.The patient is stable.
Additional Manufacturer Narrative
The bactiseal ventricular catheter (id: 823073) was not returned for evaluation (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.The root cause(s) of the reported issue could not be determined, however, the possible root cause for the ¿occlusion;¿ issues reported by the customer, could be due to biological debris occluding the catheter or a kink in the catheter.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: 21894803
• Report Number: 3013886523-2025-00083
• Device Sequence Number: 18183218
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)251031(10)7474735
• Combination Product (Y/N): Y
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 10/31/2025
• Device Catalogue Number: 823073
• Device Lot Number: 7474735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian