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
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
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) updated sections: b4,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 08/25/2025.An investigation was conducted on 08/26/2025.Only the aortic cutter was returned for evaluation.Signs of clinical use and no evidence of blood was observed.The aortic cutter was in a deployed state.There were defects observed on the intact aortic cutter.The cutter blade was observed to be bent; however, it was after the deployment of the aortic cutter and we are unable to determine when it occurred in transit.Based on the non-return of the heartstring device, and the evaluation results, the reported failure "fitting problem" was not confirmed, however, the analyzed failure "material twisted/ bent needle" 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.
Event or Problem Description
N/a.

• 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: 22923659
• Report Number: 2242352-2025-0000992
• Device Sequence Number: 9162108
• 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): 09/29/2025

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: 09/29/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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 MEDICAL PRODUCTS NEEDED.
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 96 KG