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

Model Number	HSK-3043
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
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.Medical history exceeds character limitations: ((b)(6).
Event or Problem Description
The hospital reported that the hst iii system (4.3mm) became stuck during the attempt to remove it from the plastic holder (step 4).Steps 1¿3 were carried out smoothly by the operator.The issue occurred at step 4: the disc and metal loop remained in the plastic holder, while the applicator could be withdrawn.No external mechanical damage was observed.The procedure was completed using a new device.There was no procedural delay.There was no patient harm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).Updated fields: b4, e1, e2, e3, g3, g6, h2, h6, h11.
Additional Manufacturer Narrative
(b)(4).Updated sections: b4, d9, g3, g6, h2, h3, h6, h11.The device was returned to the factory for evaluation on 12/29/2025.An investigation was conducted on 01/05/2026.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside 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 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 remained inside the loading device.The seal and tension spring assemly was removed from the loading device with no physical or visual difficulties observed.No visual defects were observed on the intact seal and tension spring assembly.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.220 inches.The length of the delivery tube was measured at 2.48 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 investigation results, the reported failure "activation problem" was not confirmed, however, the analyzed failure "fitting problem" was observed.The lot # 3000438521 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 failure.Specific actions for the reported & analyzed failure modes 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: 23664370
• Report Number: 2242352-2025-0001246
• Device Sequence Number: 18712879
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: (01)00607567700321(10)3000438521(17)251127
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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,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: 11/27/2025
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000438521
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 01/05/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/19/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 65 KG