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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Trackwise id (b)(4).
Additional 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 or Problem Description
N/a.
Event or Problem Description
N/a.
Additional 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.
Additional Manufacturer Narrative
Trackwise#:(b)(4).Updated sections.The device was returned to the factory for evaluation on 12/15/2022.An investigation was conducted on 12/27/2022.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, per requirement in ga000080 section 7.4.1.This requirement is currently being assessed under capa 1112811 in response to fda observation 4a2a.Due to the age of the complaint at the time of reassessment, the device is no longer available for further investigation.Based on the reported condition of the device the reported failure "activation problem" was confirmed.Corrected sections: d4--unique identifier (udi) # corrected from (b)(4).Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
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 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 14409048
• Report Number: 2242352-2022-00418
• Device Sequence Number: 2583782
• Product Code: DXC
• UDI-Device Identifier: 00607567700307
• UDI-Public: (01)00607567700307(10)25158011(17)220504
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/30/2024

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 01/11/2023; 10/30/2024
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 08/15/2022; 01/11/2023; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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: Unknown