MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL CL EVD 1.9MM CTH SET; BACTISEAL EVD CATHETERS

Catalog Number	821750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2024
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 facility reported a bactiseal catheter (id 821750) appeared to have broken in half when the patient moved while in the icu recovering from surgery.The catheter was implanted on (b)(6) 2024.A head computed tomography (ct) was performed to assure no parts left in the patient, but sufficient external catheter remained.The nurse noticed that the patient experienced a negative icp on monitor, a residual piece of catheter clamped and a presence of pneumocephalus on ct.The catheter was cut and reattached to collection system; however, the entire catheter was removed on (b)(6) 2024, and was not replaced.All broken parts were recovered.Patient status is progressing in care.
Additional Manufacturer Narrative
The bactiseal catheter was returned for evaluation.Failure analysis - the catheter was visually inspected; a tear was noted at the distal part.The catheter was irrigated, no occlusion was noted.The valve was leak tested and no leak noted.As only a part of device was returned the complaint could not be investigated more.Root cause analysis - the root cause for the issue reported by the customer, is due to improper handling of the device and could be caused by the patient moved.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL CL EVD 1.9MM CTH 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: 18966520
• Report Number: 3013886523-2024-00086
• Device Sequence Number: 20475737
• Product Code: JXG
• UDI-Device Identifier: 10886704040996
• UDI-Public: 10886704040996
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Catalogue Number: 821750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2024
• Supplement Report FDA Received Date: 04/19/2024
• 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