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

Model Number HST III SYSTEM (3.8MM)

Device Problem Mechanical Problem (1384)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/09/2022

Event Type  Injury  

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm proximal seal was deployed and installed in the aorta, but the bleeding did not subside.No abnormality was found on the seal when filling.Bleeding subsided when other heartstrings were prepared and used in the same manner.Proceeded with the procedure as it is and finish without any problem.The amount of bleeding increased slightly, but not enough to affect the patient's hemodynamics.The extension of the operation time was about a few minutes.No effect on the patient.

Manufacturer Narrative

Trackwise id (b)(4).

Manufacturer Narrative

Trackwise#: (b)(4).The lot # 25161182 history record review was completed.For lot # 25161182- there were ncmrs , rework, or deviations documented for the reported lot number.Ncmr #17370-on (b)(6) 2021 at around 10:30am, moisture was observed in compressed air tubing in the bioline area of eptfe manufacturing.Condensation in air line(s) may be an indication that the air compressor, bmarm id (b)(4), may not have been producing compressed air with a dew point less than or equal to +7 degrees c as required to satisfy the validation acceptance criteria per (b)(4) compressed air distribution system oq/pq protocol, rev b, section 7.7.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.H3 other text : device not returned.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 01/19/2023.An investigation was conducted on 02/08/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the devices.The safety lock on the aortic cutter was observed to be off and the needle was observed to be partially deployed.The delivery device was returned outside the loading device.The blue slide lock was observed to be off, allowing the white plunger to be depressed.The seal and tension spring assembly was returned outside the delivery device.The blue thread was observed to be cut and the seal was unraveled.No measurements were taken due to the presence of blood in the delivery tube.Based on the returned condition of the device and investigation results, the reported failure "mechanical problem" was not confirmed.The lot#: 25161182 history record review was completed.For lot#: 25161182- there were ncmrs , rework, or deviations documented for the reported lot number.Ncmr#: (b)(4) on (b)(6) 2021 at around 10:30am, moisture was observed in compressed air tubing in the bioline area of eptfe manufacturing.Condensation in air line(s) may be an indication that the air compressor, bmarm id: 00033-5, may not have been producing compressed air with a dew point less than or equal to +7 degrees c as required to satisfy the validation acceptance criteria per (b)(4) compressed air distribution system oq/pq protocol, rev b, section 7.7.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: 14594626
• MDR Text Key: 293286667
• Report Number: 2242352-2022-00486
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

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: 11/09/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25161182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose