MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEARTSTRING III SYSTEM 4.3MM; CLAMP, VASCULAR

Model Number HSK-3043

Device Problem Fitting Problem (2183)

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

Event Date 02/01/2024

Event Type  malfunction  

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.E1 event site name due to character limitations: (b)(6).

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) seal could not be fixed at the aortic hole, and then the seal was removed, which did not affect the patient.Bleeding after the seal entered the aortic hole.The seal can be opened normally, the seal can be opened in the aorta, there is bleeding, the amount of bleeding is not clear.Replace it with a new one.The operation was successful.There is no delay in the program.There was no harm due to defective device.

Event Description

N/a.

Manufacturer Narrative

Trackwise #: (b)(4).The lot # 3000327528 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.

• Brand Name: HEARTSTRING III SYSTEM 4.3MM
• 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: 18888519
• MDR Text Key: 337651232
• Report Number: 2242352-2024-00224
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• 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: 3000327528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.