MAUDE Adverse Event Report: INTEGRA LIFESCIENCES HOLDING CORPORATION DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5; DURASEAL CRANIAL

Catalog Number 202050

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

It was reported that the duraseal could not turn into hydrogel formation.There was no patient involved.Additional info was requested and on 04/27/2015 and 04/30/2015, the following was received: the product problem occurred on (b)(6) 2015 during a craniotomy surgery on a (b)(6) male patient.The duraseal could not turn into "solid hydrogel formation so the surgeon could use suction tip to remove it easily.This was clarified as the duraseal was already sprayed on the patient's brain when it did not turn into "solid" hydrogel formation.The surgeon had to use suction to remove the duraseal from the patient.The dural seal was removed easily.There was no patient injury or harm because of this.A replacement product was available to be used.There was no surgery delay.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.Method: eval of actual device; review of device history records; review of complaint history.Results: visual inspection of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported condition.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.A review of complaint data reveals no trend for a device related failure for this condition.No enhancements or improvements were generated for the reported condition.Conclusion: since the sample was returned fully applied, the root cause of the reported condition could not be reliably determined and the file will be closed.Should new info become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES HOLDING CORPORATION; plainsboro NJ 08536
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4756881
• MDR Text Key: 5788318
• Report Number: 3003418325-2015-00010
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• 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: N3L0581X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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 Age: 50 YR