MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S; SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721)

Event Type  Injury  

Event Description

The adverse event was received from sales rep.In 2021, the surgeon used the product for the first time in an s8 subarea resection operation.Although the patient was doing fine after the surgery, the patient then died of a fatal arrhythmia within a short period of time.The cause was unknown, but because of the special circumstance (that the surgeon used the product for the first time in that case), the surgeon thought that the product's formulation might have entered the blood vessels, although he was not sure about the causal relationship.He also felt that the product may have been used incorrectly, so it was not until now that the surgeon reported about this.Since it happened 2 years ago, the sales rep couldn't get any details about this.Further details are not provided by the hp.No sample will be returned.No device is available for evaluation.[surgeon's opinion about causal relationship between product and event] unknown [surgeon's comment] "although the causal relationship was unknown, i think that the product's formulation may have entered the blood vessels and caused a pulmonary embolism.".

• Type of Device: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; sydmarken 5; soeborg, 2860 ; DA 2860
• Manufacturer Contact: sydmarken 5; soeborg, 2860
• MDR Report Key: 17676018
• MDR Text Key: 322613454
• Report Number: 3008478369-2023-00011
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): Y
• PMA/PMN Number: P990004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1