MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number 202050

Device Problem Improper Chemical Reaction (2952)

Patient Problem Fluid Discharge (2686)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that duraseal dural sealant system (202050) was used on a patient with a benign tumor of the cerebral meninges with surgery performed on (b)(6) 2023.They performed resection of tumors at the base of the skull and supratentorial midline and csf fistula correction.After 15 days, the patient presented with secretion of a gelatinous and transparent substance.The duraseal material was rejected in the skull.No information on medical/surgical intervention is yet available.

Manufacturer Narrative

Duraseal dural sealant system 5ml us box of 5 (202050) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, the root cause is undetermined and was unable to be confirmed in the complaint evaluation.A dhr review and trending were performed as part of the evaluation.Proper finished good testing was performed prior to release as indicated in the dhr.Product was not received for analysis and the investigation could not confirm the complaint.Per the dfmea, potential causes of failure include: performance, sealing dura, application - gel delivery, solution mixing & coverage.The risk remains acceptable per the risk analysis.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17098857
• MDR Text Key: 317831639
• Report Number: 3003418325-2023-00010
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: 60402584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2023
• Date Device Manufactured: 12/01/2022
• 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
• Patient Sex: Male