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 Code	Insufficient Information (4580)
Date of Event	09/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that after a bactiseal evd catheter (id (b)(6)) was implanted, there was blood leaking from puncture channel where the catheter was inserted in the brain.The catheter was implanted on (b)(6) 2023 and explanted on (b)(6) 2023.The catheter was not replaced.
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
The bactiseal evd catheter (id 821749) was not returned for evaluation as the product was discarded as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, a possible root cause for the issue reported by the customer, could be due to a sharp or pointed object coming into contact with the catheter.As noted in the ifu silicone has a low cut/tear resistance.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.
Event or Problem Description
N/a.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17818545
• Report Number: 3013886523-2023-00334
• Device Sequence Number: 6161572
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: (01)10381780518440(17)240131(10)7028126
• Combination Product (Y/N): N
• PMA/510(K) Number: K090348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 821749
• Device Lot Number: 7028126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/26/2023
• Date Device Manufactured: 02/27/2023
• 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
• Patient Sex: Unknown