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	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event site name exceeds character limitations: hakodate goryokaku hospital 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.
Event or Problem Description
The hospital reported that that when the hst iii system (4.3mm) was loaded, the seal did not fit into the delivery device and remained inside the loading device.It was determined that the product could not be used clinically.New device was issued and this time it was successfully loaded and used.There was no delay in the procedure or additional treatment due to this incident.There was no harm to the patient's health.
Event or Problem Description
N/a.
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 01/14/2026.An investigation was conducted on (b)(6) 2026.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 in the loading device window.The seal and tension spring assembly were removed from the loading device with no physical or visual difficulties observed.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.The length of the delivery tube was measured at 2.49 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 confirmed.The lot # 3000473064 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.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 (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: 23969154
• Report Number: 2242352-2026-0000004
• Device Sequence Number: 18129320
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: (01)00607567700321(10)3000473064(17)260423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 04/23/2026
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000473064
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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: UNKNOWN.
• Patient Sex: Unknown