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

Model Number HST III SYSTEM (4.3MM)

Device Problem Fitting Problem (2183)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id (b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) seal did not fill tightly into the tube of the delivery device.They set it up according to the procedure, but when they pulled out the delivery device, the seal remained in the loading device.Therefore, prepare and use an alternative heartstring.Since it was before the aorta was pierced with a cutter, there was no effect on the patient such as an increase in bleed.

Manufacturer Narrative

Trackwise # (b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) seal did not fill tightly into the tube of the delivery device.They set it up according to the procedure, but when they pulled out the delivery device, the seal remained in the loading device.Therefore, prepare and use an alternative heartstring.Since it was before the aorta was pierced with a cutter, there was no effect on the patient such as an increase in bleeding.

Manufacturer Narrative

Trackwise # (b)(4) updated sections: b4, b5, e3, g4, g7, h2, h3, h6, h10 the lot # 25160806 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.The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint.H3 other text : device not returned.

Manufacturer Narrative

Trackwise # (b)(4).The device was returned to the factory for evaluation on 01/09/2023.An investigation was conducted on 01/11/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the devices.The lock of the aortic cutter was observed to be off and the needle was partially deployed.The delivery device was returned outside the loading device.The seal and tension assembly was returned inside the loading device with the seal in a folded state.The blue slide lock on the delivery device was on and the white plunger was not depressed.The seal and tension spring assembly were removed from the delivery device with no physical or visual difficulties.There were no cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.21 inches ((b)(6)).The length of the delivery tube was measured at 2.52 inches ((b)(6)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed.The lot # 25160806 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: HST 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: 14376507
• MDR Text Key: 291952767
• Report Number: 2242352-2022-00417
• Device Sequence Number: 1
• Product Code: DXC
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: HST III SYSTEM (4.3MM)
• Device Catalogue Number: HSK-3043
• Device Lot Number: 25160806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose