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

Catalog Number	821745
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2023
Type of Reportable Event	Malfunction
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 facility reported: "the icu staff development nurse was doing bedside teaching with the allocated nurse regarding evds and how to check the connections.Apparently, the above connection which is at the end of the indwelling evd catheter, and the monitoring system came apart in the nurse's hand.The evd was inserted on (b)(6) 2023 in theatre, incident occurred/reported on (b)(6) 2023.Medical staff informed, and medical staff removed broken connection and connected a new connector, from a new csf external drainage system to provide affective monitoring and drainage seal." follow up 7 days post incident and the patient did not presented signs and symptoms.The patient condition is improving post discharge from icu.
Additional Manufacturer Narrative
Evd catheter (id 821745 ) has been returned for evaluation.Failure analysis - the "evd" connector was visually inspected, a defect was noted.The connector is broken.The complaint was confirmed.Root cause - the possible root cause for the issue reported by the customer, could be due to improper handling of the device in view of the broken connector.As noted in the warnings in ifu: fibrous adhesions may bind the bactiseal evd catheter to the adjacent choroid plexus or the ventricular wall.Gentle rotation may free the catheter.Do not remove the catheter forcefully.

• 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: 16940608
• Report Number: 3013886523-2023-00145
• Device Sequence Number: 7562513
• Product Code: JXG
• UDI-Device Identifier: 10381780515593
• UDI-Public: 10381780515593
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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 Catalogue Number: 821745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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