MAUDE Adverse Event Report: COVIDIEN LP, FORMERLY US UNK DURASEAL PRODUCT; DURASEAL SEALANT

Catalog Number UNK DURASEAL

Device Problem Leak/Splash (1354)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  malfunction  

Event Description

Procedure type: superficial temporal artery-middle cerebral artery anastomosis according to the reporter: an article title "watertight dural closure constructed with duraseal for bypass surgery" by nishimura k.Kimura t.Morita a.Published in neurologia medico-chirurgica, 52 (7): 521-4, 2012 states that a study was undertaken to analyze the feasibility of using a synthetic dural sealant in superficial temporal artery-middle cerebral artery (sta-mca) anastomoses.Duraseal was sprayed over the defect and a negative pressure drain was placed.Two patients developed a temporary csf collection which disappeared after compression with a bandage in around 2 weeks.The complaints filled are only for the adverse events that directly correlate with use of duraseal.This complaint is for one of those leaks.

Manufacturer Narrative

(b)(4).

• Brand Name: UNK DURASEAL PRODUCT
• Type of Device: DURASEAL SEALANT
• Manufacturer (Section D): COVIDIEN LP, FORMERLY US; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy, qa ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3850710
• MDR Text Key: 4615947
• Report Number: 1219930-2014-00211
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2014

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: UNK DURASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other