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

Model Number HST III SYSTEM (3.8MM)

Device Problems Insufficient Information (3190); Activation Problem (4042)

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

Event Date 11/18/2021

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 an endoscopic vein harvesting procedure, hst iii system (3.8mm) misfired, no adverse effects,.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hst iii system (3.8mm) misfired, the seal did not deploy correctly.A new device was opened to complete the case.No adverse effects.

Manufacturer Narrative

Trackwise #(b)(4).

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, e3, g4, g7, h2, h3, h6, h10 the device was returned to the factory for evaluation on 12/14/2021.An investigation was initiated on 08/02/2022.Only the delivery device was returned for investigation.A visual inspection was conducted.The white plunger was observed to be depressed with the blue safety lock off.Signs of heavy clinical use and blood were visible on the entire device, including inside the delivery device handle and on the white seal and tension assembly, indicating an attempt was made to introduce the device into the aorta, hence no measurements of the delivery device were taken.The seal was observed to be in a fully open state and was fully intact, and the tension spring assembly remained inside the delivery tube.No other visual defects were observed.Based on the returned condition of the device, the reported failure "activation problem" was not confirmed.The lot 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: 12975091
• MDR Text Key: 282042999
• Report Number: 2242352-2021-01033
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25160086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 99 KG