MAUDE Adverse Event Report: RAYNHAM CODMAN BEVD 1.9MM CAT SET; BACTISEAL EVD CATHETERS

Catalog Number	821749
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported a bactiseal catheter (id 821749) was implanted on (b)(6) 2023 and several days after implantation, the catheter broke into two shortly after the patient had a computed tomography (ct) scan.The catheter was removed on (b)(6) 2023 and all pieces were recovered.The patient status is unknown, and 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6 & h10.Failure analysis - the bactiseal catheter (id (b)(6)) was not returned for evaluation but a photo was provided and confirm the broken catheter.Root cause - no root cause could be determined as the device was not returned for investigation.The possible root cause for the ¿catheter broke in two.¿ 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.

• Brand Name: CODMAN BEVD 1.9MM CAT SET
• Common Device Name: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17405458
• Report Number: 3013886523-2023-00238
• Device Sequence Number: 7121987
• Product Code: JXG
• UDI-Device Identifier: 10381780518440
• UDI-Public: 10381780518440
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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 Catalogue Number: 821749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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