MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERCLOT; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	PCUS003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) and subsequent expiration date (17) are unknown; therefore, the udi number only will contain the device identifier (01).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
The patient underwent an unspecified procedure wherein perclot was applied, and the patient experienced re-bleeding.The patient was transferred to the intensive care unit and a blood transfusion was administered.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERCLOT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ARTIVION - CRYOLIFE; 1655 roberts blvd, nw; kennesaw GA 30144
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20861134
• Report Number: 1416980-2024-07059
• Device Sequence Number: 18299656
• Product Code: LMG
• UDI-Device Identifier: 05413765891366
• UDI-Public: (01)05413765891366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P210036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PCUS003
• Device Catalogue Number: PCUS003
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown