MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BEVD 1.9MM CAT SET; BACTISEAL EVD CATHETERS

Catalog Number	821749
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Fever (1858); Unspecified Infection (1930)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a bactiseal catheter (id 821749) was implanted on (b)(6) 2024.On (b)(6) 2024, the physician found a minimal amount of cerebrospinal fluid (csf) leaking at the end of the catheter, where it was connected to the lure-connector.The catheter was removed on the same day and a small hole was found at the end of the catheter.After the procedure, the patient experienced an infection-related fever with a temperature of 39°c.Additional information was requested; however, it was not provided.
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
N/a.
Additional Manufacturer Narrative
The bactiseal catheter (id 821749) was returned for evaluation.Device history record (dhr): the product code 82-1749 with lot 7361173, conformed to the specifications when released to stock.All finished goods test results, including endotoxin satisfactorily met the requirements.Failure analysis: the catheter was visually inspected; no defect was noted.No tests could be performed as the catheter is very short.Root cause analysis: no root cause could be determined as the catheter is very short.The possible root cause for the issue reported by the customer, could be due to improper handling of the device or could be due a sharp or pointed object coming into contact with the catheter.
Additional Manufacturer Narrative
This follow-up is to make a correction in the follow-up sent on 12/06/2024: g3 - awareness date is 11/25/2024 (not 10/25/2024).

• Brand Name: CODMAN BEVD 1.9MM CAT SET
• Common Device Name: BACTISEAL EVD CATHETERS
• 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: 20212942
• Report Number: 3013886523-2024-00284
• Device Sequence Number: 18015883
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: (01)10381780518440(17)250131(10)7361173
• Combination Product (Y/N): N
• PMA/510(K) Number: K090348
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2025

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 Expiration Date: 01/31/2025
• Device Catalogue Number: 821749
• Device Lot Number: 7361173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 04/02/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/06/2024; 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian