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

Catalog Number 821750

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2024

Event Type  Injury  

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 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.

• Brand Name: BACTISEAL CL EVD 1.9MM CTH SET
• Type of Device: 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
• MDR Text Key: 338433817
• Report Number: 3013886523-2024-00086
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K090348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 821750
• Date Manufacturer Received: 03/06/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1