MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HEARTSTRING III PROXIMAL SEAL; CLAMP, VASCULAR

Model Number	HS-3045
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
Related to (b)(4).The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) could not be loaded correctly, the inserter did not get the seal loaded, although all loading steps were carried out correctly, the seal remained in the loader when the inserter was pulled out of the loader.A replacement device was used to complete the procedure.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Corrected sections: e1-- initial reporter/event site email corrected from "(b)(6)." the device was returned to the factory for evaluation on 07/07/2023.An investigation was conducted on 07/18/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.The delivery device was returned inside the loading device.A mechanical evaluation was conducted.An attempt was made to load the seal into the delivery device.When performing step 2 of the loading procedure, a greater than normal amount of force had to be applied to push the delivery device down and for the "2" to slide into the window on the loading device.The delivery device was pulled out from the loading device and the seal and tension spring assembly remained in the loading device.The seal and tension spring assembly were removed from the loading 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 0.194 inches, the outer diameter was measured at 0.219 inches.The length of the delivery tube was measured at 2.525 inches (mcv00004217).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 # 3000261689 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 PROXIMAL SEAL
• Common Device Name: 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: 17290282
• Report Number: 2242352-2023-00554
• Device Sequence Number: 12143465
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: HS-3045
• Device Catalogue Number: HS-3045
• Device Lot Number: 3000261689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown