MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL BARIUM STRIPED CATH; BACTISEAL CATHETER KIT

Catalog Number	NS0340
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	04/19/2024
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 certas valve (id 828814) and bactiseal catheter (id ns0340) were implanted due to unknown reason via ventriculoperitoneal (v-p) shunt on unknown date with unknown setting.There was a leakage of cerebrospinal fluid (csf) in the chamber.A debris was seen in the valve, however no damage was found in the valve.Therefore, both the valve and catheter were removed.According to the information provided, it is unknown if the catheter was replaced.The estimate amount for csf leakage is not known.It is also unknown if the patient has any signs or symptoms related to the csf leak.The patient's current status is unknown.
Additional Manufacturer Narrative
The bactiseal catheter (id ns0340) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; 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 BARIUM STRIPED CATH
• Common Device Name: BACTISEAL CATHETER KIT
• 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: 19346834
• Report Number: 3013886523-2024-00144
• Device Sequence Number: 20456105
• Product Code: JXG
• UDI-Device Identifier: 10381780524076
• UDI-Public: 10381780524076
• Combination Product (Y/N): N
• PMA/510(K) Number: K031123
• 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): 07/12/2024

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: NS0340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 VALVE (ID 828814)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown