MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN BACTISEAL EVD CATHETER; BACTISEAL EVD CATHETERS

Model Number	821745
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that on saturday (b)(6) 2022, the patient had a bactiseal evd catheters (b)(6) implanted as an evd and connected to a medtronic becker drainage system.At that time, there were no problems with the catheter upon insertion noticed.On sunday, (b)(6) 2022, the patient was taken to get a ct scan.The patient was placed into the ct, the drainage system was turned off and the placed on the patient¿s chest while receiving the scan.When the patient came out of the ct scan, the bactiseal evd catheter had fractured in half.This was noticed by the staff.They immediately clamped off the catheter with a hemostat.The distal portion of the catheter that was still implanted into the patient was subsequently trimmed, the luer connector was then placed into the newly trimmed portion of the catheter and a new medtronic becker drainage system was attached.There was no tugging or pulling on the catheter before or during the ct.It is unknown if the catheter was damaged by something internal in the ct machine.The patient is currently fine with regards to what happened with the bactiseal evd.
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 evd catheter (id 821745) is not available for evaluation: remains implanted, but a photo was provided showing cut/tear in the catheter, therefore, complaint is confirmed.Device history record (dhr) - lot 6495050 conformed to the specifications when released to stock.Root cause - no root cause could be determined as the device was not returned for investigation.The possible root cause for the issue reported by the customer, could have been 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.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• Common Device Name: BACTISEAL EVD CATHETERS
• 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: 15583121
• Report Number: 3013886523-2022-00465
• Device Sequence Number: 6385547
• Product Code: JXG
• UDI-Device Identifier: 10381780515593
• UDI-Public: (01)10381780515593(17)230630(10)6495050
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 821745
• Device Catalogue Number: 821745
• Device Lot Number: 6495050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 03/03/2023
• Date Device Manufactured: 07/12/2022
• 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