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

Model Number HST III SYSTEM (3.8MM)

Device Problem Material Separation (1562)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id: (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.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).While firing the cutter from the heartstring, the device came apart in the surgeon's hand.The cutter did deploy and make an acceptable hole in the aorta.There was no delay in procedure.There was no harm to the patient.

Event Description

N/a.

Manufacturer Narrative

Trackwise #: (b)(4).The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.However a photograph was provided by the account.Signs of clinical use and evidence of blood was observed.The aortic cutter case was observed to be split in half at the base.The aortic cutter needle was observed to be in a fully deployed state.No other visual defects were observed.Based on the photographic inspection, the reported failure "material separation" was confirmed.A lot history record review was completed for lots 25161523, 25161574, and 25162876 the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.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: 15800764
• MDR Text Key: 303801570
• Report Number: 2242352-2022-00939
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1