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

Model Number HST III SYSTEM (3.8MM)

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/08/2021

Event Type  Death  

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm).The umbrella could not be detached intra-aortically and the system did not seal the aortic hole.During an emergency myocardial revascularization with the impella pump in place, the use of a partial aortic clamp was not possible (due to the anteriorly located impella catheter).Therefore use of a heart-string device, with the failure of the umbrella to unfold in the aortic lumen with consequent bleeding from the punched opening.

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.

Manufacturer Narrative

Trackwise # (b)(4).Corrected sections: b2 - outcome attributed to ae changed to death; h1 - type of report changed to death; h6 - health effect changed to bleeding; h6 - health effect impact - changed to death.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).The umbrella could not be detached intraaortically and the system did not seal the aortic hole.During an emergency myocardial revascularization with the impella pump in place, the use of a partial aortic clamp was not possible (due to the anteriorly located impella catheter).Therefore use of a heart-string device, with the failure of the umbrella to unfold in the aortic lumen with consequent bleeding from the punched opening.The operation was then continued without hsk.The blood was aspirated from the aortotomy using a cell saver, reprocessed and given to the patient.No further blood donations were necessary and no additional blood was given.No further incisions were necessary.The aortic hole was sutured.In this surgical situation, the heartstring and the problem with it had no indication of actual or potential damage or death.According to hospital, the heartstring had nothing to do with the patient's death.The patient already had a very advanced heart attack and was also resuscitated.The patient died because of a catheter accident and the complication of the catheter accident.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (b)(4) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (b)(4) 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: (b)(4) the overall 24 month product complaint trend data for the period dec -2019 through nov-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (b)(4) 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 12/20/2021.An investigation was initiated on 03/11/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the loading device as well as the delivery device and seal which indicates an attempt was made to introduce the device into the aorta.The delivery device was returned outside the loading device.The white plunger was fully depressed and the blue safety lock was off which allows for the white plunger to be depressed.The seal was observed to be an fully opened deployed state.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties.No cracks or delamination was observed on the opened seal.No measurements of the delivery device were taken due to the presence of blood.Based on the returned condition of the device and the evaluation results, the reported failure "failure to unfold or unwrap" was not confirmed.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section: h1- type of reportable event- corrected to "death".

Event Description

N/a.

• 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: 12909659
• MDR Text Key: 281581635
• Report Number: 2242352-2021-01000
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2022
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25157245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/14/2021; 03/31/2022; 05/12/2022
• Supplement Dates FDA Received: 12/23/2021; 03/31/2022; 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.; UNK.; UNKNOWN.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 62 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 82 KG