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 Activation Problem (4042)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/22/2022

Event Type  Injury  

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).There was no calcification and loading was performed as usual, but bleeding was abnormally large and it became a procedure to switch to the side clamp.The amount of bleeding was not the amount that required a blood transfusion.The seal was deployed in the aorta, but the bleeding was severe, whether the seal was in a bad shape or in a bad position.It is clearly different from when they use it all the time, and it seems that the product is defective.The new heart string is not used and it is supported by the side clamp.No harm to the patient.

Manufacturer Narrative

Trackwise id (b)(4).

Manufacturer Narrative

Trackwise # (b)(4) updated sections: b4, e3, g3, g4, g7, h2, h3, h6, h10 the lot # 25158011 history record review was completed.There were ncmrs, rework, or deviations documented for the reported lot number.Ncmr #17314- per section 7.7 of gamma processing of products 90519293/rev bk, sterile load number 0300010706 was released with the incorrect sterilization test results documented on the cycle review checklist ¿ gamma cycle form.The sterilization results documented were for sterile lot no: 0300010708 instead of sterile lot no: 0300010706.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 Description

N/a.

Event Description

N/a.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation on (b)(6) 2022.An investigation was conducted on (b)(6) 2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the device.Only the delivery device was returned.The blue safety lock was observed to be off and the white plunger was not depressed.Blood was observed inside the delivery tube, indicating an attempt was made to introduce the seal into the aorta.The seal was observed to be partially out of the delivery tube but still in an undeployed state.A mechanical evaluation was conducted.The seal was removed from the delivery device.There were no cracks or delamination observed on the seal.No measurements of the device were taken due to the presence of blood in the delivery tube.Based on the reported condition of the device the reported failure "activation problem" was confirmed.The lot # 25158011 history record review was completed.There were ncmrs, rework, or deviations documented for the reported lot number.Ncmr #(b)(4) per section 7.7 of gamma processing of products (b)(6) rev bk, sterile load number 0300010706 was released with the incorrect sterilization test results documented on the cycle review checklist ¿ gamma cycle form.The sterilization results documented were for sterile lot no: 0300010708 instead of sterile lot no: 0300010706.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
• 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: 14409048
• MDR Text Key: 291734898
• Report Number: 2242352-2022-00418
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2022
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25158011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention