MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.3MM); CLAMP, VASCULAR

Model Number HST III SEAL (4.3MM)

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/09/2022

Event Type  Injury  

Event Description

Related to (b)(4).The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.3mm) , hemostasis could not be stopped because clemme did not deploy.The seal did not remain inside the delivery tube.The seal was inserted into the aorta and used as usual.Attempts were made to achieve adequate hemostasis.They had no choice but to clamp to complete the anastomosis.No blood transfusions were required and there was no procedural delay.The product was out of stock and was clamped and operated to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device not returned.

Manufacturer Narrative

#trackwise # (b)(4).The lot 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 Description

N/a.

• Brand Name: HST III SEAL (4.3MM)
• 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: 14593853
• MDR Text Key: 293277757
• Report Number: 2242352-2022-00468
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700321
• UDI-Public: 00607567700321
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2022
• Device Model Number: HST III SEAL (4.3MM)
• Device Catalogue Number: HS-3043
• Device Lot Number: 25161479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UINKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male