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

Model Number HST III SYSTEM (3.8MM)

Device Problems Mechanical Problem (1384); Fitting Problem (2183)

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

Event Date 07/04/2022

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

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) wing was stuck and the seal was not used.The operation was completed using the same new product.There was no abnormality in the patient's condition.

Manufacturer Narrative

Trackwise id # (b)(4).

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 3000238892 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 07/11/2022.Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was observed outside the loading device with the seal and tension spring assembly inside the loading device.The seal was observed in the loading device window, no cracks or delamination was observed on the seal.The blue wings were observed to be in the normal position.The white plunger of the delivery device was not depressed and the blue safety was on, which prevents the white plunger from being depressed.The plunger on the aortic cutter was observed to be intact, and in an undeployed state.An investigation was conducted on 08/03/2022.The delivery device was returned outside the loading device with the seal and tension spring assembly inside the loading device window.The white plunger was not depressed and the blue safety was on, which prevents the white plunger from being depressed.The seal and tension spring assembly was removed from the loading device with no visual or physical difficulties.There were no cracks or delamination observed on the intact seal.A mechanical evaluation was conducted.The blue wings on the loading device were depressed with no physical or visual difficulties observed.The blue wings went back to their original position when released.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.218 inches (b)(6).The length of the delivery tube was measured at 2.51 inches (b)(6).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed, but was not confirmed for the reported failure "mechanical problem".

• 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: 15073504
• MDR Text Key: 304624684
• Report Number: 2242352-2022-00637
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2022

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: 04/30/2023
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 3000238892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/03/2022; 09/08/2022
• Supplement Dates FDA Received: 08/22/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1