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 Codes	Fitting Problem (2183); Activation Problem (4042)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trackwise id (b)(4).
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure, seal did not fill into the tube of the delivery device.The seal did not load properly.At the setting stage, there was no seal inside the tube.They set it according to the procedure, but could not do it many times, so they rolled the seal by hand and filled it in the tube and tried to deploy it in the aorta, but the seal was caught in the tube and could not be deployed.Therefore, prepare and use an alternative heartstring.There was a delay of a few minutes.There was some increase in bleeding, but no additional blood transfusions were needed.No effect on the patient.
Additional Manufacturer Narrative
Trackwise id (b)(4).
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation on (b)(6) 2023.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the delivery device and loading device.The delivery device was returned outside the loading device with the seal partially inside the delivery tube in a taco shape.The white plunger was depressed and the blue safety lock was off, which allows for the white plunger to be depressed.The center of the seal was observed to be partially unraveled.The seal and tension spring assembly was removed from the delivery device with no physical or visual difficulties 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 "fitting problem" was not confirmed.The reported failure "activation problem" was confirmed, as well as the analyzed failure "seal unravels" was observed.
Event or Problem Description
N/a.

• 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: 15071025
• Report Number: 2242352-2022-00625
• Device Sequence Number: 20162178
• 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,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 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: 06/30/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 09/20/2022; 01/16/2023
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/12/2022; 09/20/2022; 01/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose