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	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 07/20/2026.An investigation was conducted on 8/18/2026.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device and the intact seal and tension spring was returned outside the loading device with the white plunger not depressed and the blue safety lock on, which prevents the white plunger from being depressed.There were no visual defects observed on the intact seal or tension spring assembly.Measurements of the delivery device were taken; the inner diameter was measured at 0.195 inches; the outer diameter was measured at 0.219 inches (rm2036883).The length of the delivery tube was measured at 2.49 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 failures "fitting problem" and "detachment of device or device component" were not confirmed.The lot #3000500748 history record review was completed.There was an ncmr, rework, or deviation documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is a relation between the batch manufacturing process and the reported failures.

• 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: 50137927
• Report Number: 2242352-2026-0000654
• Device Sequence Number: 10730486
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: (01)00607567700314(10)3000500748(17)260902
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 08/05/2026

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: 09/02/2026
• Device Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000500748
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown