MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM); CLAMP, VASCULAR

Model Number	HSK-3043
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
Related to (b)(4).The hospital reported that the hst iii system (4.3mm) failed to deploy after the surgeon had prepared it for use.A second hst iii system (4.3mm) was requested, but it also failed.The procedure was completed using another device.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11 the lot # 3000459992 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 failure.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 02/11/2026.An investigation was conducted on 03/04/2026.Signs of clinical use and evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger depressed and the blue safety lock off , which allows the white plunger to be depressed.The delivery device was removed from the loading device with no physical or visual difficulties observed.The seal and tension spring assembly was not returned for evaluation.No measurements of the device were taken due to the presence of blood in the delivery tube, per requirement.Based on the returned condition of the device as well as the investigation results, the reported failure "activation problem" was not confirmed.
Event or Problem Description
N/a.

• Brand Name: HST III SYSTEM (4.3MM)
• 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: 23501377
• Report Number: 2242352-2025-0001181
• Device Sequence Number: 8904571
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: (01)00607567700321(10)3000459992(17)260301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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 Expiration Date: 03/01/2026
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000459992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 03/16/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/12/2025; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown