MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL BARIUM STRIPED PERIT; BACTISEAL PERITONEAL CATHETER

Catalog Number	NS0339
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 3 of 3 reports linked to mfg report number: 3013886523-2024-00262.3013886523-2024-00263.A physician reported a hakim valve (id 823162) was implanted due to unknown reason via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.After the patient was born, she was treated with meningocele, and an ommaya reservoir was implanted.Three weeks after birth, the hakim valve was implanted.The ventricular catheter (id ns0338) was implanted from dorsal horn, but it penetrated choroid plexus and it entered temporal horn.In addition, peritoneal catheter (id ns0339) had coiled up in abdominal cavity.Therefore, due to suspicion of obstruction; the valve, ventricular and peritoneal catheter were removed and replaced on (b)(6) 2024.The patient recovered.According to information provided, it is unknown if the patient had any signs and symptoms due to the product problem.
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.
Additional Manufacturer Narrative
Additional information received: "during the implantation, ventricular catheter penetrated chorioid plexus.Few days after the implantation, diagnostic imaging confirmed that the ventricular catheter came off and the peritoneal catheter had fallen off.A revision surgery was performed on (b)(6) 2024.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id (b)(6)) was returned for evaluation.Failure analysis - the catheter was visually inspected; no defects were noted.The catheter was irrigated, no occlusion noted.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.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL BARIUM STRIPED PERIT
• 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: 20087163
• Report Number: 3013886523-2024-00264
• Device Sequence Number: 7811148
• Product Code: JXG
• UDI-Device Identifier: 10381780524069
• UDI-Public: 10381780524069
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• 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,Followup
• Report Date (Section B): 01/09/2025

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: NS0339
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 12/19/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 10/04/2024; 01/09/2025
• 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: HAKIM VALVE (ID 823162).; VENTRICULAR CATHETER (ID NS0338).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 MO
• Patient Sex: Female