MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number	HSK-3043
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw (b)(4) event site name exceeds character limitations: (b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
The hospital reported that during procedure the delivery device of the hst iii system (3.8mm) was loaded normally according to the instructions for use (ifu), but the seal became caught on the tip of the loader, preventing smooth removal and attachment.The seal got stuck in the loading device prior to deployment in the aorta.The device was immediately replaced with a new one.There was a 7-10 min delay.
Additional Manufacturer Narrative
B)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.Photos were received from the hospital and it is observed that the seal remained inside the loading device.The device was returned to the factory for evaluation on 02/05/2026.An investigation was conducted on 02/10/2026.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger not depressed and the blue safety lock on, which prevents the white plunger from being depressed.The seal was observed in the loading device window.The delivery device was removed from the loading device with no physical or visual difficulties observed.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties observed.No visual defects were observed on the intact seal and tension spring assembly.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.220 inches ((b)(4)).The length of the delivery tube was measured at 2.48 inches ((b)(4)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device as well as the evaluation results, the reported failure "fitting problem" was confirmed.The lot # 3000456346 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.

• Brand Name: HST III SYSTEM (3.8MM)
• 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: 24399285
• Report Number: 2242352-2026-0000092
• Device Sequence Number: 15493607
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: (01)00607567700321(10)3000456346(17)260217
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 02/17/2026
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000456346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown