MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR BACTISEAL PERITONEAL CATHETER

Catalog Number	823074
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Date of Event	06/14/2023
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 1 of 2 reports linked to mfg report numbers: 3013886523-2023-00210.A physician reported that on (b)(6) 2023, redness was observed along the course of bactiseal peritoneal catheter (id 823074).An allergy to bactiseal catheter was suspected, therefore the valve shunt including the bactiseal were removed on unknown date.A central nervous system (cns) infection was also found in the cerebrospinal fluid in the valve system, although the intracerebral parenchyma was normal on removal and cerebrospinal fluid examination the valve is a certas (id 828804) and according to information provided it is unknown if the valve failed and it is unknown why was removed.It is also unknown if the patient has known allergies.The type of infection or organism as well as the tests done to confirm the infection are unknown.Treatment given was not provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The bactiseal catheter (id (b)(6)) was not returned for evaluation as the product is not available for return as per customer; 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.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 PERITONEAL CATHETER
• Common Device Name: BACTISEAL PERITONEAL CATHETER
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17299923
• Report Number: 3013886523-2023-00209
• Device Sequence Number: 3864190
• 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): 08/10/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 823074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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: 828804 CERTAS INLIN VLV W/SPHNGD; ILASCON® LUMBAR CATH (KANEKA) PROD ID: 702-JJ)
• Patient Sex: Female