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	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id: (b)(4).
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure using hst iii seal (4.5mm), 5-pack.They followed the procedure, but a sticker (seal) remained in the delivery device.A replacement device was used to complete the procedure.
Additional Manufacturer Narrative
Trackwise # (b)(4).
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure using hst iii seal (4.5mm), 5-pack.They followed the procedure, but a sticker (seal) remained in the delivery device.A replacement device was used to complete the procedure.No procedural delay.There was no patient effect.
Additional Manufacturer Narrative
Trackwise # (b)(4).Updated sections: b4, g4, g7, h2, h6, h10.The lot # 25161070 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.
Additional Manufacturer Narrative
Trackwise # (b)(4).Corrected section: h6-investigation findings -device returned, h3- if other provide code -explain- device returned the device was returned to the factory for evaluation on 01/19/2023.An investigation was conducted on 02/08/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the loading device.The delivery device was returned inside the loading device.A mechanical evaluation was conducted.When performing step 2 of the loading procedure, a greater than normal amount of force had to be applied to push the delivery device down and for the "2" to slide into the window on the loading device.After the force was applied, the delivery device was loaded normally and the seal was deployed with no physical difficulties.He 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 0.196 inches, the outer diameter was measured at 0.22 inches ((b)(4)).The length of the delivery tube was measured at 2.52 inches ((b)(4)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "activation problem" was not confirmed, however the analyzed failure "fitting problem", was confirmed.
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: 14853043
• Report Number: 2242352-2022-00582
• Device Sequence Number: 17442073
• 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: Physician
• 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: 11/01/2022
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25161070
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/21/2022; 09/14/2022; 02/13/2023
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 08/25/2022; 09/14/2022; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: Prefer Not To Disclose