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

Model Number HSK-3038

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

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Injury  

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) after deploying aortic cutter, visual inspection of aortotomy showed a deformed aortotomy with tears on the margin.Customer reports a "[loud] unusual sound" when aortic cutter was deployed; an unexpected click was noticed.When the cutter was removed, it was noticed that the hole made in the aorta was much larger than expected and small micro tears were noticed coming off of the hole in the aorta.No obvious defects were seen with the aortic cutter.The aortic plug did come back with the cutter (nothing was lost in the patient).The heartstring was deployed.However, due to the size of the hole, the seal immediately fell out of the aorta.The hole was covered with a finger and a new seal was opened from a 4.3 mm heartstring box.This seal was deployed and the surgeon and his assistant held the seal in place with a forceps so it would not fall out of the aorta.There was no need to use a side clamp or cross clamp to complete the anastomosis.The surgeon stated that about 800 cc to 1000 cc of blood was lost during the proximal anastomosis.The patient was still on the bypass machine so this lost blood was suctioned and immediately given back to the patient.No blood transfusions were required.The proximal anastomosis was finished and a the heartstring was removed.The potential micro tears were sewn into the suture line of the anastomosis so they would no longer be a concern.This issue did add about 35 to 40 minutes to the surgery time.No harm or injury was caused to the patient.There was no concern with either heartstring seal that was used.

Manufacturer Narrative

Tw id#(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.H3 other text : device discarded.

Event Description

N/a.

Manufacturer Narrative

Trackwise#: (b)(4).A ship history was completed.There was no evidence that the reported upn was sold to the account during the year prior to the date opened date.(event date was not provided.) a lot history is unable to be performed.The account was unable to provide the lot number.

• Brand Name: HEARTSTRING 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: 18727604
• MDR Text Key: 335701361
• Report Number: 2242352-2024-00123
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HSK-3038
• Device Catalogue Number: HSK-3038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FORCEPS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG