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	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) could not be inserted correctly.When the hst iii system (3.8mm) was pulled out, the entire system became stuck.The seal remained in the charging device.The seal did not make contact with the patient¿s aorta.Another one was opened, and the same defect occurred.Both heartstring devices were used on the same patient.In both cases, after steps 1 through 3 proceeded without incident, step 4, the removal of the charged device, occurred.At this point, everything remained in the charging system, and i was left holding only the empty casing.Procedure could be performed with an alternative device (enclose).There was no major delay for the patient, however, we then had to clamp the ascending aorta tangentially.No harm to the patient; can be completed without further problems.Based on the provided photo the seal is still in the loading device.Related to (b)(4).
Additional Manufacturer Narrative
(b)(4).Event site name exceeded character limitations: (b)(6).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.

• 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: 50852349
• Report Number: 2242352-2026-0000823
• Device Sequence Number: 21209288
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000553427
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 04/15/2026
• 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: Unknown.
• Patient Age: 52 YR
• Patient Sex: Male