MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (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 Description

Related to (b)(4).The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal failed to deploy.The white plunger was pressed but the seal did not make contact with the patient's aorta.The blue slide was locked in an unlocked state.There was no procedural delay.A replacement device was used to complete the procedure.No patient adverse effects.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 25160720 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.The device was returned to the factory for evaluation on 05/31/2022.An investigation was conducted on 06/01/2022.A visual inspection was conducted.Only the delivery device was returned for evaluation.Signs of clinical use and evidence of blood was observed on the delivery device which indicates an attempt was made to introduce the device into the aorta.The white plunger was fully depressed and the blue safety was off, which allows the white plunger to be depressed.The seal was not returned for evaluation.No measurements of the delivery device were taken due to the presence of blood.Based on the returned condition of the device as well as the evaluation results, the reported failure "activation problem" was not confirmed.

• Brand Name: HST III SYSTEM (3.8MM)
• 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: 14594254
• MDR Text Key: 294052484
• Report Number: 2242352-2022-00476
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25160720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 69 KG