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

Model Number HST III SYSTEM (3.8MM)

Device Problems Unraveled Material (1664); Activation Problem (4042)

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

Event Date 10/07/2021

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 using hst iii system (3.8mm).After punching with aortic cutter during off pump cabg, in the process of inserting the delivery system and shooting, the anchor part did not straighten properly, so the seal loosened while adjusting the position, and it was replaced with a new product of the same type.After this, the operation was successfully completed without additional bleeding or adverse reactions in the patient.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were 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.Historical data analysis for similar complaints: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure modes.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual: (10/213/67) the device was returned to the factory for evaluation on 10/18/2021.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device.The seal was observed to be in an unraveled state out of the device.The white plunger and blue slide lock was not observed in the photograph.The aortic cutter was observed to have blood on it and the device was capped.An investigation was conducted on 10/20/2021.Signs of clinical use and evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger fully depressed and the blue slide lock disengaged.The seal was observed to be an unraveled state outside the delivery device.The tension spring assembly was not returned for evaluation.No measurements of the delivery device were taken due the presence of blood which indicates an attempt was made to introduce the device into the aorta.Based on the photographic inspection as well as the returned condition of the device, the reported failures "activation problem" and "unraveled material" was not confirmed.

• Brand Name: HSK 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: 12707972
• MDR Text Key: 279056744
• Report Number: 2242352-2021-00882
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

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: 05/17/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25158272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG