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	04/08/2026
Type of Reportable Event	Malfunction
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
The hospital reported that the hst iii system (3.8mm) was loaded normally using the delivery device in accordance with the usage guidelines (ifu), but a issue occurred where the seal got caught on the tip of the loader and could not be smoothly separated and installed.The device was immediately replaced with a new one.Reloading and installation were subsequently successfully performed, and the repair was completed without any issues.There was a procedural delay of approximately 7¿8 minutes.There was no harm or adverse effect to the patient, and the patient is currently recovering.

• 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: 25011310
• Report Number: 2242352-2026-0000313
• Device Sequence Number: 21406369
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: (01)00607567700314(10)3000497496(17)260811
• 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): 04/27/2026

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: 08/11/2026
• Device Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000497496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown