MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL, UNKNOWN; DURASEAL CRANIAL

Catalog Number XXX-DURASEAL

Device Problem Fumes or Vapors (2529)

Patient Problems Asthma (1726); Wheezing (4463)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Ats journal (2017) published an article titled: "reactive airway dysfunction syndrome (rads) in a surgeon after exposure to duraseal fume in the operating room." introduction: reactive airways dysfunction syndrome (rads) is a variant of occupational asthma defined as a sudden onset of asthma-like symptoms following a single exposure to high levels of irritating aerosol, vapor, fume, or smoke.Case presentation: 43 year old orthopedic male surgeon was exposed to high level of duraseal fumes, which were piped into the operating room during an operation.After three hours of exposure; he started to have dizziness, confusion, nausea, dyspnea and coughing.He had to break the scrub, stop the surgery, leave the area and leaving the or and rushing to the emergency department (ed) immediately.On physical exam, diffuse expiratory wheezing was noted on auscultation.He was given albuterol inhaler, and intravenous steroid to ameliorate his symptoms.He has no previous history or asthma or any other lung disease.Pulmonary function test (pft) revealed 77% of forced expiratory volume in 1 second (fev1), increased by 27% after administration of a bronchodilator.Patient was started on budesonide-formoterol inhaler, levalbuterol inhaler and 40 mg oral prednisone.After 6 days, repeated pft was normal.Patient stopped taking oral prednisone after 4 months secondary to weight gain, thereafter; he had multiple visits to the ed for reactive airway exacerbations provoked by grill smoking and dust in a construction area, with overall decreased functional capacity.An eight-month repeat of pft revealed 83% of fev1, increased by 19 % after administration of a bronchodilator.Discussion: duraseal is a newly fda-approved spine sealant used to enhance sealing of the dura in spinal surgeries.It was never reported previously to cause any type of occupational asthma to the staff in the operating room.Asthmatic symptoms in rads last anywhere between 3 months and 12 years in some case reports.In our case, the symptoms relapsed after oral steroid discontinuation which may indicated the rule of more extended course of systemic steroid treatment in rads.This case also underscores the potential for the development of rads in health care workers even in the operating room.Https://www.Atsjournals.Org/doi/pdf/10.1164/ajrccmconference.2017.195.1_meetingabstracts.A3843?download=true.

Manufacturer Narrative

Duraseal (unknown catalog#) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was not received for analysis and the investigation could not confirm the complaint.While the reported complaint could not be confirmed based on the information provided, the event description of duraseal fumes being piped into the operating room is not possible.Duraseal does not come from outside the operating room.If used in conjunction with micromyst, and the applicator is air assisted.The pressurized air comes from the wall of the surgical suite, not from the product itself.Duraseal does not have an odor and does not contain volatile ingredients.Per the fmea, a failure mode of ¿assembled product does not function properly¿ could lead to an extended delay in patient treatment, with a possible root cause of: labeling, instructions for use not being followed.The risk remains acceptable per the risk analysis.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, UNKNOWN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17191426
• MDR Text Key: 317818498
• Report Number: 3003418325-2023-00012
• 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,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2023
• 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