MAUDE Adverse Event Report: Maquet Cardiovascular LLC HST III System (3.8MM); Clamp, Vascular

Model Number	HSK-3038
Medical Device Problem Codes	Fitting Problem (2183); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that there was an attempted to load a hst iii system (3.8mm) into a delivery device using the ifu method during an opcab surgery.However, the seal became stuck on the loader, preventing normal loading, and the delivery device handle detached.Determined to be a product defect, a new product was used, and the surgery was successfully completed.The patient's condition is stable.Based on the photo provided by the complainant, the seal got stuck inside delivery device.There was a procedural delay of approximately 7 minutes.
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.

• 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: 50815062
• Report Number: 2242352-2026-0000813
• Device Sequence Number: 10210894
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: (01)00607567700314(10)3000568981(17)270611
• 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
• Report Date (Section B): 09/18/2026

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: 3000568981
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2026
• 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 Sex: Unknown