MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP DURASEAL, UNKNOWN; DURASEAL CRANIAL

Catalog Number XXX-DURASEAL

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Post operative csf leak was reported.It was unknown if the event lead to an increase of surgery time.The issue was detected because of a market study on duraseal.Linked to mfg.Report number: 3003418325-2017-00019.

Manufacturer Narrative

Additional information received on 8nov2017.It was reported that the surgeon had a couple of patients that he operated for a spinal cord lipoma where he used duraseal and leaked.To the best of his recollection, the leak was present under the skin since day one or two post op.Then it came through the skin and the patients needed to go back to the theatre for a wound repair.In one occasion, he had to leave the wound open and redress it in the theatre every other day for a couple of weeks.His patients are all pediatric.It happened in 2015/2016.It was reported that these lipoma cases were particularly challenging and it is very difficult to obtain a watertight closure.Often the edges were imperfect and the dural patch leaves a few holes patent.The surgeon has now stopped using any sealant since he doesn¿t believe they can be of any help.He spends more time suturing the patch, reduce the size of the opening and reinforce the construct with additional superficial layers.No further additional information was provided.

Manufacturer Narrative

Integra has performed a thorough review of the reported incident.There was no product received back (device used), and no lot number identified, as such a dhr review could not be performed.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be determined, as there is no way to reliably determine why the reported condition occurred.

• Brand Name: DURASEAL, UNKNOWN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7022926
• MDR Text Key: 91769836
• Report Number: 3003418325-2017-00020
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other