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	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 reported that the hst iii seal (4.5mm), 5-pack loaded correctly, but the seal was not fully inserted and came off the tube.The seal exited the delivery tube on actuation.The dark gray actuation button at the top was pressed.An audible click upon actuation and the seal remaining inside the delivery tube upon planned delivery into the aorta was not done therefore, they used another heart-string instead of using this product.The patient has no health hazards.
Additional Manufacturer Narrative
Trackwise#: (b)(4).
Event or Problem Description
The reported that the hst iii seal (4.5mm), 5- pack loaded correctly, but the seal was not fully inserted and came off the tube.The seal exited the delivery tube on actuation.The dark gray actuation button at the top was pressed.An audible click upon actuation and the seal remaining inside the delivery tube upon planned delivery into the aorta was not done therefore, they used another heart-string instead of using this product.There is no processing delay.The patient has no health hazards.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise#: (b)(4).The device was returned to the factory for evaluation on 05/03/2023.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned outside the loading device with the white plunger not depressed and the blue safety on, which prevents the white plunger from being depressed.The seal and tension spring assembly was observed in the delivery device., but not in its normal seated position.The seal was observed to be in deployed and opened state.A mechanical evaluation was conducted.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties observed.There were no visual defects observed on the seal, no cracks or delamination was observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.197 inches, the outer diameter was measured at 0.227 inches (rm2036883).The length of the delivery tube was measured at 2.49 inches (mcv00004217).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device as well as the evaluation results, the reported failure "activation problem" was not confirmed but the analyzed failure "fitting problem" was observed.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.

• 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: 16709764
• Report Number: 2242352-2023-00292
• Device Sequence Number: 12290100
• 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
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 05/19/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/01/2023; 05/19/2023
• 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: Unknown