MAUDE Adverse Event Report: 3-D MATRIX EUROPE PURASTAT; HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE

Model Number	621-035
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: patient was an active bleed during the procedure receiving blood transfusion.Multiple types of intervention were done and the pura stat was delaying care.A second syringe of pura stat was used without difficulty.

• Brand Name: PURASTAT
• Common Device Name: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE
• Manufacturer (Section D): 3-D MATRIX EUROPE; 1234 chestnut st, ste 205; newton MA 02464
• MDR Report Key: 22814265
• Report Number: 22814265
• Device Sequence Number: 9014344
• Product Code: QAU
• UDI-Device Identifier: 04560436590354
• UDI-Public: (01)04560436590354
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025
• Report Date (Section F): 08/12/2025

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
• Operator of Device: Health Professional
• Device Model Number: 621-035
• Device Catalogue Number: 621-062
• Device Lot Number: 23B23A30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Date Report Sent to FDA: 08/12/2025