MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BACTISEAL VENTRICULAR CATHETER

Catalog Number	823073
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3013886523-2023-00349.3013886523-2023-00351.A physician reported that during surgery, cerebrospinal fluid flow was confirmed when the ventricular catheter was inserted.However, no cerebrospinal fluid flow was observed after the certas valve (828800), bactiseal peritoneal catheter (823074), and bactiseal ventricular catheter (823073) were connected.The procedure was completed with a replacement product available.No adverse consequences to the patient were observed and the event led to more than 30 minutes surgical delay.
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.
Additional Manufacturer Narrative
The bactiseal ventricular catheter (id 823073) was returned for evaluation.Device history record (dhr) - product code 823073 with lot 7028049, conformed to the specifications when released.Failure analysis - the catheter was visually inspected: no defects were found.The catheter was irrigated no occlusions noted.The complaint is unconfirmed.Root cause analysis ¿ no root cause for the issue reported by the customer could be determined as no defects could be found with the catheter.A possible root cause for the issue reported by the customer could be due to catheter susceptible to kinking which could lead to an occlusion.As seen in the investigation, no occlusion was found with the catheter.
Event or Problem Description
N/a.

• Brand Name: BACTISEAL VENTRICULAR CATHETER
• Common Device Name: BACTISEAL VENTRICULAR CATHETER
• 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: 17906714
• Report Number: 3013886523-2023-00350
• Device Sequence Number: 7897752
• Product Code: JXG
• UDI-Device Identifier: 10381780515623
• UDI-Public: (01)10381780515623(17)240131(10)7028049
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 01/31/2024
• Device Catalogue Number: 823073
• Device Lot Number: 7028049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL PERITONEAL CATHETER (ID823074).; CERTAS PLUS VALVE (ID828800).
• Patient Sex: Unknown