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

Catalog Number 202050

Device Problems Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Meningitis (2389)

Event Date 04/01/2016

Event Type  Injury  

Event Description

This is the first of two reports (same product, same hospital, same physician, same incident, different patients).This report is in regards to the duraseal.Linked to mfg report: 3003418325-2016-00011 ((b)(4)).It was reported that a (b)(6) male patient developed meningitis after undergoing a resection of glioblastoma multiforme (gbm) procedure wherein the physician closed with duraseal sealant system 5ml.There was also concomitant use of bp10608 bp suturable graft 6 cm x 8 cm.The physician had stated when he revised the defect, it was obvious only the "graft" was infected.The incident occurred on (b)(6) 2016.The patient was immunocompromised and treated with heavy doses of steroids after the gbm resection.The physician stated that he has performed over 200 craniotomies at this hospital and these 2 incidents of infection are his first.Additional information has been requested.Additional information received from integra physician on 27apr2016 (sent to him on (b)(6) 2016): the csf analysis demonstrated findings consistent with a bacterial meningitis.There was a high wbc count with neutrophil predominance, high protein and low glucose.There was no significant elevation in the eosinophil count.The csf cultures were positive for staph in both patients.The bovine graft was sent to pathology which again demonstrated findings consistent with a bacterial infection, without significant lymphocyte or eosinophil elevation.Duraseal was sprayed over the entire graft.Both patients were found to have glioblastoma multiforme and required extended periods of steroids postoperatively.Both patients underwent surgery within a week of each other.I have used duraseal/bovine pericardium in the past with cranial patients without problems, but they did not have glioblastoma requiring extended steroids.These are the only glioblastoma patients in which duraseal / bovine pericardium was used.

Manufacturer Narrative

Additional information was received on 02 may 2016 from the user facility (integra received after hours on 29apr 2016 at 8:39pm).There was no serial number available, the term duraseal "rowen" in an unfamiliar term to the staff and the nurse supervisor.The quantity of duraseal used was 5 ml.No other information was available or provided.

Manufacturer Narrative

Integra has completed their internal investigation on 07 jul 2016.The product was not returned for evaluation.As no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with the finished product specifications for all released lots.A review of historical complaint data displayed no increase in trends.Conclusion: the product sample was not returned for analysis.Without the sample and without a valid lot/serial number, a detailed investigation could not be performed.If additional information is obtained, or the sample is returned, the investigation will be re-opened.

• Brand Name: DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5
• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5621175
• MDR Text Key: 44141170
• Report Number: 3003418325-2016-00010
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 202050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• 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): Required Intervention
• Patient Age: 50 YR