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

Model Number	HS-3045
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
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
The hospital reported that after setting up the hst iii seal (4.5mm), for a coronary artery bypass procedure they inserted the delivery device into the patient's aorta and pushed the plunger, but it was not released correctly and the tension spring was caught in the tube and pulled out.When the delivery device was pulled out, the seal also came out of the aorta, so they did not reinsert it.Bleeding was slightly increased, but not enough to affect the patient's hemodynamics.No additional blood transfusions were required.When another heartstring was prepared and used in the same way, it could be placed in the aorta without any problems.Proceed with the procedure as it is, and the operation will be completed without any problems.The extension of operation time was several minutes.No patient was harmed.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The lot #3000248143 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.H3 other text: device not returned.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 03/23/2023, however, the product was brought to the lab on 05/17/2023 for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery tube.The seal was observed in the delivery device in a deployed state.Slight blood was observed on the intact seal, no cracks or delamination was observed.No measurements of the delivery device were taken due to the presence of blood , which indicates an attempt was made to introduce the device into the aorta.Based on the returned condition of the device as well as the evaluation results, the reported failure "activation problem" was not confirmed.The lot #3000248143 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 or Problem Description
N/a.

• 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: 16336726
• Report Number: 2242352-2023-00108
• Device Sequence Number: 6873119
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/19/2023

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: 06/10/2023
• Device Model Number: HS-3045
• Device Catalogue Number: HS-3045
• Device Lot Number: 3000248143
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 06/01/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 05/11/2023; 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose