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); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure hst iii seal (4.5mm), 5-pack, the seal was not loaded and remained in the loader, making it unusable, so the new item was opened and the surgery was completed successfully.There was no problem for the patient.
Additional Manufacturer Narrative
Trackwise id # (b)(4).Corrected section: h6 from 4020 to 2183.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise # (b)(4).The lot # 25160936 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
(b)(4).Corrected sections: h6--component code corrected from "jaw" to "seal" 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 no evidence of blood were observed on the device.The delivery device was returned outside the loading device with the blue slide lock observed to be on and white plunger not depressed.The seal and tension assembly was returned inside 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 0.198 inches, the outer diameter was measured at 0.22 inches (b)(6).The length of the delivery tube was measured at 2.52 inches (b)(6).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 # 25160936 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: 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: 14734394
• Report Number: 2242352-2022-00531
• Device Sequence Number: 14964355
• 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): 02/10/2023

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: 10/25/2022
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25160936
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 09/12/2022; 02/10/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/12/2022; 09/13/2022; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose