MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR

Model Number	HST III SEAL (4.5MM), 5-PACK
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id: (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure the hst iii seal (4.5mm), was used and the hemostatic seal was not pushed out of the rotary device when the white plunger button was pressed and pulled out.A new device was used and the operation was completed without any problems and there was no impact on the patient.
Additional Manufacturer Narrative
Trackwise id # (b)(4).Updated section: b-4, b-5, g-4, g-7, h-2, h-10.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure the hst iii seal (4.5mm), was used and the hemostatic seal was not pushed out of the rotary device when the white plunger button was pressed and pulled out.The seal was in contact with the patient's aorta.The seal did not appear to spread significantly- 3.3 diameters.The blue slide was locked in the unlocked position.No peeling/cracking of the seal was observed before or during the loading of the seal.The seal came out, but the tension spring part did not.A new device was used and the operation was completed without any problems and there was no impact on the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h3, h6, h10.The lot 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.
Additional Manufacturer Narrative
Trackwise # (b)(4).Corrected section: h4- if other provide code -explain- device returned, h6 -investigation findings (1) removed code "3221"- device returned, h6 -type of investigation removed code " 4114- device returned.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.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 depressed and the blue safety off, which allows for the white plunger to be depressed.The seal was observed in a deployed open state.No cracks or delamination was observed on the seal.A mechanical evaluation was conducted.The seal and tension spring assembly was removed from the delivery device with no visual or physical difficulties observed.No cracks or delamination was observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 1.97inches, the outer diameter was measured at 0.218 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.The lot #25159879 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: HST III SEAL (4.5MM), 5-PACK
• 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: 15325273
• Report Number: 2242352-2022-00721
• Device Sequence Number: 6484380
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/18/2023

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: 08/27/2022
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25159879
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 10/14/2022; 05/18/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/27/2022; 10/14/2022; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.; UNK.; UNKNOWN.
• Patient Sex: Unknown