MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	HSK-3043
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Related to: (b)(4).The hospital reported that during a coronary artery bypass procedure, four hst iii system (4.3mm) did not load in the delivery tube.This occurred during the same case and involved the same patient.Opened another kit to complete the procedure.The only delay was the length of time to open a new kit.No patient injury.
Additional Manufacturer Narrative
(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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 (b)(6) 2025.An investigation was conducted on (b)(6) 2025.The loading device was returned taken apart with the cover of the loading device off the base of the device as well as the blue wings not inside the loading device.Signs of clinical use and evidence of blood was observed on the loading device.The delivery device 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.The seal and tension spring assembly was observed outside the loading device.The seal was detached from the tether with the blue string intact.No other visual defects were observed.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.The length of the delivery tube was measured at 2.50 inches.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 failure "fitting problem" was not confirmed, however, the analyzed failure "detachment of device or device component" was observed.The lot # 3000474241 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.

• Brand Name: HST III SYSTEM (4.3MM)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 22923649
• Report Number: 2242352-2025-0000991
• Device Sequence Number: 18421122
• Product Code: GEI
• UDI-Device Identifier: 00607567700321
• UDI-Public: (01)00607567700321(10)3000474241(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 04/30/2026
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000474241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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: NO.
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 96 KG