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

Model Number HSK-3038

Device Problems Premature Activation (1484); Fitting Problem (2183); Material Twisted/Bent (2981)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

(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, hst iii system (3.8mm) punched it with an aortic cutter.It was loaded properly with the step 1234 procedure.The white plunger was pressed when attempting to load the seal into the delivery device.After the punch, opened it by shooting into the aorta from the delivery handle.The seal was open, but it didn't unfold properly in the aorta.The bleeding wasn't significant because they were blocking the aortic hall with their hand during the replacement.However, due to a defect in the product, a new, identical product was used and the surgery was completed successfully.Per photo provided by complainant, the needle on the cutter was slightly bent, the white plunger was fully pressed in while inside the loading device and no evidence of blood, and the seal remained inside the loading device.There were no abnormalities in the patient's condition.A little delayed due to the affected product exchange to the new one.No harm.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/26/2024.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use were observed on the aortic cutter and heartstring devices.Evidence of blood was only observed on the aortic cutter.The aortic cutter was observed to be fully deployed and the needle was bent.The delivery device was observed to be inside the loading device.The blue slide lock and white plunger were not fully visible in the photograph.The seal was observed in the window of the loading device with no cracks or delamination.An investigation was conducted on 02/27/2024.A visual inspection was conducted.Signs of clinical use were observed on the aortic cutter and heartstring devices.Evidence of blood was only observed on the aortic cutter.The aortic cutter was observed to be fully deployed and the needle was bent.The delivery device was returned inside the loading device.The blue slide lock was observed to be off, however the white plunger was not depressed.The placement of the seal and delivery device in the loading device indicates a previous attempt may have been made to load the device.A mechanical evaluation was conducted.An attempt was made to load the seal into the delivery device.The seal did not fold correctly in the delivery tube.The seal was unfolded when the delivery device was removed from the loading device, with the tension spring remaining in the delivery tube.There were no cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.195 inches, the outer diameter was measured at 0.221 inches.The length of the delivery tube was measured at 2.50 inches ((b)(4)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and evaluation results, the reported failures "fitting problem" and "material twisted/ bent; needle" were confirmed", however the reported failure "premature deployment" was not confirmed.The lot # 3000332869 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 failures.

• 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: 18864380
• MDR Text Key: 337219068
• Report Number: 2242352-2024-00207
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2024

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-3038
• Device Catalogue Number: HSK-3038
• Device Lot Number: 3000332869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1