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

Model Number	HSK-3038
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) was unusable because the seal did not come out during setup.Apparently, it remained inside the loader and could not be removed.No contact with the patient.Pressed.The device does not touch the aorta because a seal remains inside.A substitute product was used, and the procedure was completed.There was no delay in the procedure, and no health damage to the patient.
Additional Manufacturer Narrative
Tw (b)(4).The device has been returned to the factory and will be evaluated.A supplemental report will be submitted when the evaluation is completed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Tw (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 04/27/2026.An investigation was conducted on 04/28/2026.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the loading device.The delivery device was returned inside the loading device with the white plunger depressed and the blue safety lock off , which allows for 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.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.219 inches (rm2036883).The length of the delivery tube was measured at 2.48 inches (mcv00004217).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 not confirmed.Reported lot # 3000487063 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.

• 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: 25034869
• Report Number: 2242352-2026-0000318
• Device Sequence Number: 15747081
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: (01)00607567700314(10)3000487063(17)260620
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 06/20/2026
• Device Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000487063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown