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

Model Number HST III SYSTEM (3.8MM)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  Injury  

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 normal seal loading, aorta punch was performed using an aortic cutter.A situation in which the side wall is perforated occurs.Although the aorta punch was performed in a normal way and the patient's aorta diameter was within the sufficient normal range, the aorta wall was punctured and the medical staff decided that it was difficult to proceed with opcab surgery.While proceeding with opcap, aorta wall was punched so the medical staff decided to switch it to "on-pump".No additional incisions made.There was slight additional bleeding.No procedural delay.No clinical harm to the patient.

Manufacturer Narrative

Trackwise id#: (b)(4).Updated sections: b4, e1 event site email, g-4, g-7, h-2, h3, h-6,h-10 analysis of production: (3331/213 & 67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213 & 67) a review of the historical data indicates that no other similar complaints was reported for the same lot 25158272 and reported failure mode.Trend analysis: (4110/213/67) 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: (4111/213 & 67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10 /213 & 67) a photo inspection was conducted based on the pictures received.One photo shows the delivery device with the seal hanging from its tip; an aortic cutter with a the needle extended.Both devices were tainted with blood.The other photo shows the device label.The device was returned to the factory for evaluation on 11/15/2021.An investigation was conducted on 11/23/2021.A visual inspection was conducted.Signs of clinical use and heavy amounts of blood were observed on the aortic cutter as well as on the delivery device and seal.The white plunger was fully depressed on the delivery device and the seal was in a fully opened position.Blood was observed inside the delivery device as well as on the seal indicating an attempt was made to introduce the device into the aorta.The aortic cutter was observed to be in a fully deployed state with heavy amounts of blood indicating an attempt was made to introduce the device into the aorta.There were no visual defects observed on either the delivery device and seal or the aortic cutter.Based on the returned condition of the device, there were no visual defects observed, and no specific failure was reported.

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: 12845273
• MDR Text Key: 281028297
• Report Number: 2242352-2021-00988
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• 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: C-HSK-3038
• Device Lot Number: 25158272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 60 KG