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

Model Number HST III SYSTEM (3.8MM)

Device Problem Break (1069)

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

Event Date 04/29/2022

Event Type  malfunction  

Manufacturer Narrative

(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

The hospital reported that during an endoscopic vein harvesting procedure, hst iii system (3.8mm), following activation of aortic cutter, it was shown to have separated after deployment.The protective cap on the aortic cutter was removed and the safety lock on the aortic cutter was released prior to deployment.No harm to the patient.The case was completed with heartstring seal in kit.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 05/06/2022.An investigation was conducted on 06/01/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The end where the deployment button is located was observed to be in half.There were no other visual defects observed.Based on the returned condition of the device, the reported failure "break" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.Specific actions for the failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 25162417 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.

• 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: 14471190
• MDR Text Key: 292391371
• Report Number: 2242352-2022-00442
• 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: 12/16/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25162417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1