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

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/21/2022

Event Type  Injury  

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).They used it as usual, but they couldn't stop the bleeding.They opened a new one and was able to use it.There is no problem with the patient.

Manufacturer Narrative

Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm) was deployed properly.The seal opened in the aorta but did not stop bleeding.Probably did not fit the blood vessels.Open another new one and try again with the same procedure.The procedure is finished.There is no problem with the patient.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period mar -2020 through feb-2022 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device: (10/13/22) the device was returned to the factory for evaluation on 03/15/2022.An investigation was conducted on 03/16/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the loading device as well as on the end of the delivery device.The delivery device was returned outside the loading device with the white plunger not depressed and the blue safety lock on which prevents the white plunger from being depressed.The seal and tension spring assembly was observed in the body of the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties.No cracks or delamination was observed on the intact seal.No measurements of the delivery device were taken due to the presence of blood on the tip of the delivery device which indicates an attempt was made to introduce the device into the aorta.Based on the returned condition of the device, the reported failure "leak" was not confirmed but was confirmed for the analyzed failure "fitting problem".

• Brand Name: HST III SEAL (4.5MM), 5-PACK
• Type of Device: 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: 13824990
• MDR Text Key: 288052652
• Report Number: 2242352-2022-00239
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: 00607567700307
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: C-HS-3045
• Device Lot Number: 25160936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male