MAUDE Adverse Event Report: 3-D MATRIX EUROPE SAS PURASTAT; HEMOSTATIC DEVICE

Model Number	621-035
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Manufacturer received a medwatch report describing a device malfunction during patient use.Event description from health professional: describe the event or problem: 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.What was the original intended procedure? egd.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction - that is, the device did not do what it was supposed to do; therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known.
Additional Manufacturer Narrative
The report is being submitted based on the information currently available.Attempts were made to obtain additional information; however, no further details have been received to date.Device evaluation could not be performed as the product was not returned.Should additional information be received, a supplemental medwatch report will be filed.

• Brand Name: PURASTAT
• Common Device Name: HEMOSTATIC DEVICE
• Manufacturer (Section D): 3-D MATRIX EUROPE SAS; 11 chemin des petites brosses; caluire et cuire, 69300 ; FR 69300
• Manufacturer Contact: audrey vion ; 11 chemin des petites brosses; caluire et cuire, 69300 ; FR 69300
• MDR Report Key: 23555783
• Report Number: 3012263097-2025-00001
• Device Sequence Number: 10160339
• Product Code: QAU
• UDI-Device Identifier: 04560436590354
• UDI-Public: (01)04560436590354(17)260222(10)23B23A30
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K242250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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 Expiration Date: 02/22/2026
• Device Model Number: 621-035
• Device Catalogue Number: 621-042
• Device Lot Number: 23B23A30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 92 KG