MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (4.3MM); CLAMP, VASCULAR

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	07/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during preparation for an endoscopic vein harvesting procedure, patient was in the room.Hst iii system (4.3mm) was damaged coming out of the box.They were unable to squeeze the blue wings together to roll up the proximal seal.The device never came in contact with the patient.Another heartstring was pulled from the shelf to finish the case.No harm to patient.No procedural delay.
Additional Manufacturer Narrative
(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Additional Manufacturer Narrative
Tw #: (b)(4).Updated sections: b4,d9,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 08/15/2025.An investigation was conducted on 08/202/205.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the loading device.The delivery device was returned inside the loading device.The seal was observed in the loading device window.The delivery device was removed from the loading device with no physical or visual difficulties observed.The seal and tension spring assembly was observed loaded in the delivery device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties.There were no visual defects observed on the tension spring assembly.However, a crack was observed on the seal.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 ((b)(6)).The length of the delivery tube was measured at 2.50 inches ((b)(6)).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" and the analyzed failure crack were both confirmed.The lot # 3000479466, 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: 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: 22698525
• Report Number: 2242352-2025-0000912
• Device Sequence Number: 8869852
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: (01)00607567700321(10)3000479466(17)260520
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/16/2025

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: 05/20/2026
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000479466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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 CONCOMITANT MEDICAL PRODUCTS.
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 78 KG