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

Model Number HST III SYSTEM (3.8MM)

Device Problems Premature Activation (1484); Activation Problem (4042)

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

Event Date 06/10/2021

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 a coronary artery bypass procedure, hst iii system (3.8mm) misfired.No adverse effects.No pt harm.

Manufacturer Narrative

Trackwise id# (b)(4).Corrected section: b5- narrative, h6- corrected to "4042".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: (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 mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period apr 2019 through may 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/suspected device (10/213/67).The device was returned to the factory for evaluation on 07/13/2021.An investigation was conducted on (b)(6) 2021.A visual inspection was conducted.The delivery device, seal and tension spring assembly was returned for evaluation.Signs of clinical use and evidence of blood was observed on the delivery device as well as on the seal indicating an attempt was made to introduce the device into the aorta.The white plunger on the delivery device was fully depressed and the blue slide lock was disengaged.The seal and tension spring assembly was returned inside the delivery device with the tension springs observed to be backwards in the delivery device.The seal was observed to be fully open.The anchor was observed to be outside the delivery device.No measurements of the delivery device were taken due to the presence of blood.Based on the returned condition of the device, the reported failure "activation problem" was not confirmed as the tension spring assembly was observed to be not in its normal loaded position.

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) miss-fired, the seal did not deploy/release correctly.A new heartstring was opened to complete the case.No adverse effects.No pt harm.

• Brand Name: HSK III SYSTEM (3.8MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 12093062
• MDR Text Key: 259174217
• Report Number: 2242352-2021-00533
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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: 11/24/2021
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25155098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/20/2021
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 99