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	07/15/2026
Type of Reportable Event	Malfunction
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 07/20/2026.Photographs were provided.Product information was observed.The seal was observed in the loading device body.The delivery device was observed outside the loading device.An investigation was conducted on 8/19/2026.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.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.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly were removed from the loading device with no physical or visual difficulties observed.The seal was observed to be unraveled at the center of the seal.The seal was also observed to be detached from the tether with the blue string still attached.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 and the photographic evaluation, the reported failure "fitting problem" was confirmed as well as the analyzed failures "premature deployment", "detachment of device or device component" and "unraveled seal" were observed.The lot # 3000541610 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 or the analyzed failures.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.

• 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: 50151644
• Report Number: 2242352-2026-0000661
• Device Sequence Number: 9407383
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: (01)00607567700314(10)3000541610(17)270305
• 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): 08/06/2026

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: 3000541610
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown