MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL DS3 SPINE 5ML US; DURASEAL

Catalog Number 206520

Device Problem Leak/Splash (1354)

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Swelling (2091)

Event Date 05/04/2014

Event Type  Injury  

Event Description

Procedure: spine.On (b)(6) 2014, clinical affairs became aware of a serious adverse event associated with one of covidiens product lines as part of the (b)(6) post-approval study.Two boxes were opened and the site was unable to determine which was used.Subject number: (b)(6).Onset date: (b)(6)-2014.Resolved: continuing.Severity: mild.Relationship to device: definite.Outcome: continuing.Summary of events: subject (b)(6) is an (b)(6) caucasian male with a past medical history of low back pain and degenerative disk disease.The subject had previous surgery at c3/4 and had a loose spinous process removed at t2.On (b)(6) 2014, the subject was admitted to (b)(6), where dr.(b)(6) performed a foraminotomy and decompressive procedure at l2-s1 to treat spinal stenosis.During the procedure: an incidental dural tear occurred, which was closed with sutures.The length of the incision is unk.Duragen was placed over th tear, and the area was then sealed with duraseal (amount unk).Once a watertight closure was obtained, the wound was then closed with sutures.A black drain was placed.On (b)(6) 2014 (post-op dat (b)(6)), swelling and tenderness at the surgical site was noted.The event was diagnosed as a csf leak and treated with a blood patch.The event is currently ongoing.The pt categorized this event was definitely related to duraseal.

Manufacturer Narrative

(b)(4).

• Brand Name: DS3 SPINE 5ML US
• Type of Device: DURASEAL
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISION; 60 middletown avenue; north haven CT 06473
• Manufacturer Contact: sharon murphy, qa ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3911584
• MDR Text Key: 4489379
• Report Number: 1219930-2014-00487
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 206520
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2014
• Initial Date FDA Received: 06/27/2014
• 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
• Patient Age: 83 YR