MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR

Model Number	HS-3045
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Related to (b)(4).The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) were loaded appropriately but were not hemostatic at all and bled much more than usual.The seal was removed and another loaded hs was inserted.The same scenario occurred and the second hs was removed.A third was inserted, again with the same outcome and a fourth was inserted.The surgeon removed the fourth since there was still the excessive bleeding and placed a side-biting clamp on the aorta to complete the single anastomosis.Anastomosis was completed without further incident.No patient injury.
Additional Manufacturer Narrative
(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) were loaded appropriately but were not hemostatic at all and bled much more than usual.The seal was removed and another loaded hs was inserted.The same scenario occurred and the second hs was removed.A third was inserted, again with the same outcome and a fourth was inserted.The surgeon removed the fourth since there was still the excessive bleeding and placed a side-biting clamp on the aorta to complete the single anastomosis.The surgeon depressed the white plunger and he did deploy each hs seal into the aorta.The seal did unfurl (unfold).There was a procedural delay since multiple heartstrings needed to be prepared and deployed.Anastomosis was completed without further incident.No patient injury.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, b5, g3, g6, h2, h6, h11.Corrected section: b1, b2, d4 lot # and udi, h1 - type of reportable event to "serious injury".
Additional Manufacturer Narrative
Tw#(b)(4).Updated fields: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.The device was not returned to maquet cardiac surgery for investigation; therefore, no evaluation could be performed.It is not possible to confirm the reported complaint.The lot # 3000428264 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported event.

• Brand Name: HST III SEAL (4.5MM), 5-PACK
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 21778525
• Report Number: 2242352-2025-0000395
• Device Sequence Number: 8000657
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: (01)00607567700307(10)3000428264(17)251016
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K130382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2025
• Device Model Number: HS-3045
• Device Catalogue Number: HS-3045
• Device Lot Number: 3000428264
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 05/08/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/01/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO CONCOMITANT PRODUCTS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown