MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	09/05/2024
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 physician reported a bactiseal preitoneal catheter (id 823074) and a certas valve (id 828804) were implanted on (b)(6) 2024, due to secondary normal pressure hydrocephalu (snph), via ventriculoperitoneal (vp) shunt.The patient developed "ventricular dilatation", therefore, due to obstruction, the devices were removed, and the patient was placed on external drainage.Then, a new valve (competitors) was implanted.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g4, g6, h2, h3, h6, h11.The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Failure analysis: the catheter was visually inspected, no defects noted.The catheter was irrigated, no occlusions noted.The catheter was leak tested; no leaks were noted.The complaint could not be confirmed.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 PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL 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: 20524519
• Report Number: 3013886523-2024-00327
• Device Sequence Number: 7984005
• Product Code: JXG
• UDI-Device Identifier: 10381780537007
• UDI-Public: 10381780537007
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 823074
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 07/31/2025
• 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: CERTAS INLIN VLV ONLY W/SPHNGD (ID 828804)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male