MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebral Edema (4403)
Date of Event	03/12/2024
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 peritoneal catheter (id 823074) was implanted due to unknown reason and unknown date via lumbar-peritoneal (l-p) shunt with unknown setting.The patient developed subcutaneous hydrops two weeks post-surgery.The peritoneal catheter was located within the cavity.A hole in the catheter was suspected to cause hydrops due to no issues observed during the ligation.The device was removed and examined; however, no hole was found.The catheter was cut and replaced with a new one.The patient is currently under follow-up.According to information provided, the catheter explant date is unknown.It is also unknown if there was any problem detected with the valve.
Additional Manufacturer Narrative
The bactiseal peritoneal catheter (id 823074) was returned for evaluation.Failure analysis - the catheter was visually inspected, no defects noted, the ends of the catheter parts seemed to be clean cut.The catheter parts were leak tested, no leaks noted.Root cause analysis - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any holes in the catheter at the time of investigation.The possible root cause for the issue reported by the customer, could be due to the fact that only parts of the catheter were returned for investigation, it is possible that the parts not returned had a hole.However, it was not possible to confirm and identify the root cause of this assumption as not all the catheter was returned for investigation.If more parts of the catheter are received, this complaint will be re-opened, and evaluated.
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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19054386
• Report Number: 3013886523-2024-00102
• Device Sequence Number: 6986260
• Product Code: JXG
• UDI-Device Identifier: 10381780515630
• UDI-Public: 10381780515630
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• 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): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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): Follow-Up
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/02/2024
• 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
• Patient Sex: Unknown