MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL 5ML 5 KITS/BOX FOR CANADA; DURASEAL CRANIAL

Catalog Number 209005

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.Linked to mfg report number 1121308-2020-00069.

Event Description

Ths is 2 of 2 reports.A facility reported the patient had an infratentorial - chiari surgery using duragen 3x3 and duraseal 5ml to close the dura on (b)(6) 2020.The duragen was used with the suturing technique and the duraseal was applied to the matrix.The patient had a cerebrospinal fluid (csf) leak complication, no surgical delay was reported.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

Duraseal (209005) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.Per the fmea, potential causes of failure include: performance, application - gel delivery, solution mixing and coverage.The risk remains acceptable per the risk analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DURASEAL 5ML 5 KITS/BOX FOR CANADA
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1000 campus drive; 1000 campus drive; princeton NJ 08536
• MDR Report Key: 10872887
• MDR Text Key: 217336958
• Report Number: 3003418325-2020-00021
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1