MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO HEMOSTATIC MATRIX KIT WITH THORMBIN; SURGIFLO HEMOSTATIC MATRIX KIT WITH THORMBIN PRODUCT CODE 2993

Lot Number 244984

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Hematoma (1884)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

A number of clinical questions has been asked to clarify the event.(b)(4).

Event Description

Surgeon states that he used 3 units of surgiflo hemostatic matrix kit with thrombin on a pt who underwent an anterior cervical fusion with discectomy.The pt had no issues during the case.The pt later developed a massive hematoma in the neck and went in cardiac arrest.The pt revived and is doing well now per the surgeon.The staff at the hospital reported that the pt was a smoker but no other info about the pt was revealed.There is no additional info at this time.

Manufacturer Narrative

(b)(4).This report is our follow-up and final report.Summary of information provided: surgiflo hemostatic matrix kit with thrombin product code 2993 was used on a male patient who underwent an anterior cervical fusion with discectomy.The case took 3.5 hours and it is noted that the patient had a blood loss of 100ml.No complications in the initial post-op period were noted.The following day around lunch time the patient developed neck swelling that progressed to airway obstruction and respiratory arrest.The patient was re-operated and a hematoma was evacuated and drained for about 125ml.Following this the patient was doing fine and the patient was discharged home with no further complications.It is noted that the patient is a smoker.Evaluation and conclusion: batch file review has been performed and it is evaluated that there are no deviations with relation to this complaint.A number of clinical questions were asked as to obtain additional information.Multiple attempts were made to obtain the answers with only some of the questions being answered.The case has been evaluated by an external medical advisor who evaluates the following: the case is noted to have taken 3.5 hours which is somewhat longer than what would be anticipated for such a type of procedure.Three units of surgiflo hemostatic matrix kit with thrombin product code 2993 were used during the case which could indicate that there has been a substantial amount of bleeding during the case.During such a type of procedure there is a risk that the thyroid artery can be injured which then may evolve into post-operative bleeding and consequently development of hematoma.Based on the information received and external evaluation it is concluded that the adverse event is not caused as a result of the use of surgiflo hemostatic matrix kit with thrombin product code 2993.As per the enclosed instructions for use of surgiflo hemostatic matrix kit with thrombin product code 2993 there are two warnings: surgiflo is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.Surgiflo should not be used in instances of pumping arterial hemorrhage.It should not be used where blood or other fluids have pooled or in case where the point of hemorrhage is submerged.The case is hereby considered closed.Single-use product.

Event Description

"surgeon states that he used 3 units of surgiflo hemostatic matrix kit with thrombin on a patient who underwent an anterior cervical fusion with discectomy.The patient had no issues during the case.The patient later developed a massive hematoma in the neck and went in cardiac arrest.The patient revived and is doing well now per the surgeon.The staff at the hospital reported that the patient was a smoker but no other information about the patient was revealed.There is no additional information at this time.".

• Brand Name: SURGIFLO HEMOSTATIC MATRIX KIT WITH THORMBIN
• Type of Device: SURGIFLO HEMOSTATIC MATRIX KIT WITH THORMBIN PRODUCT CODE 2993
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: majbrit andersen ; sydmarken 5; soeborg, 2860 ; DA 2860
• MDR Report Key: 5015753
• MDR Text Key: 23520563
• Report Number: 3008478369-2015-00008
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,unknown
• Reporter Occupation: Other
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Lot Number: 244984
• Other Device ID Number: N/K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2015
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening