MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEARTSTRING III SYSTEM 4.3MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number HSK-3043

Device Problem Failure to Unfold or Unwrap (1669)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) seal was released into the blood vessel, but when the delivery device was pulled, the seal also came out.It is not known if a finger was placed over the aortotomy to hold the seal in place.There was some blood loss, but not much.No blood transfusion was necessary.A new device was used to complete the procedure.There was no delay.There was no health hazard to the patient.

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.

Manufacturer Narrative

Trackwise #: (b)(4).Updated sections: b-4, g-3, g-6, h-2, h-6, h-10.The lot # 3000347059 history record review was completed.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 batch manufacturing process and the reported failure.

Event Description

N/a.

• Brand Name: HEARTSTRING III SYSTEM 4.3MM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 18870736
• MDR Text Key: 337375664
• Report Number: 2242352-2024-00221
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HSK-3043
• Device Catalogue Number: HSK-3043
• Device Lot Number: 3000347059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.