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

Catalog Number 202050

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

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 neurosurgeon reported that the duraseal glue (product id (b)(4)) was unable to syringe out and clot at the syringe's tip site.It happened just few minutes after preparation.The product was in contact with the patient with no patient injury and no delay in surgery.Additional information has been requested.

Manufacturer Narrative

Updated fields: d9, g3, g6, h2, h3, h6, h10.Additional information - the facility has advised that the indication for use of duraseal was an endoscopic transphenoidal pituitary adenoma procedure.Failure analysis - duraseal sealant (202050) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Additionally, the lot number provided by the customer (n0g07166y) does not belong to a valid production lot number; the closest lot number identified in our records is n0g0166y manufactured in august 2020.A dhr review and trending was performed on closest lot number n0g0166y as part of the evaluation.Proper finished good testing is performed prior to release as indicated on the product dhrs.Root cause analysis - the investigation could not confirm the complaint reported condition, and the root cause is undetermined since the product was not received for analysis,.Per the dfmea, potential causes of failure include: performance, adhesion barrier.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.

Event Description

N/a.

Manufacturer Narrative

Duraseal dural sealant system 5ml box of 5 (202050) was returned for evaluation: device history record (dhr): dhr review was performed and determined there were no anomalies found in association to the complaint incident.Failure analysis: evaluation was unable to conclusively verify customer information as valid.The visual inspection of the returned product noted that the caps were fully depressed, the blue pre-cursor was fully applied, and the clear syringe was fully applied.There was some liquid in the powder vial.The reported complaint is unconfirmed.Root cause analysis: 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 received for analysis and the investigation could not confirm the complaint.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11668879
• MDR Text Key: 245538793
• Report Number: 3003418325-2021-00009
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Device Lot Number: N0G0166Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 05/13/2021; 02/28/2022
• Supplement Dates FDA Received: 05/26/2021; 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1