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

Model Number HST III SYSTEM (4.3MM)

Device Problem Crack (1135)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/06/2022

Event Type  Injury  

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) was found that the umbrella had cracks, which could not stop the blood flow.The parachute did not enter the aorta.No extra blood transfusion.No surgical delay.A replacement device was used to complete the procedure.No harm to the patient.

Manufacturer Narrative

(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.

Manufacturer Narrative

Trackwise#: (b)(4).The lot # 25162889 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 Description

N/a.

• Brand Name: HST III SYSTEM (4.3MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 14594656
• MDR Text Key: 293286486
• Report Number: 2242352-2022-00484
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25162889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 67 KG