MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM); CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2022

Event Type  Injury  

Event Description

Related to (b)(4).The hospital reported that during a coronary artery bypass procedure hst iii system (3.8mm) they had an issue with bleeding and it appeared the hole created by the aortic cutter was too big or too small.Attempts were made to achieve adequate hemostasis.No reported delays or additional blood transfusions.No patient effects and the same device was used to complete the case.

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 discarded.

Manufacturer Narrative

Trackwise # (b)(4).Updated section: b4, g4, g7, h2, h6, h10 a lot history record review was completed for lots 25161742, 25161829, and 25161131 the last 3 lots shipped to the account prior to the event/aware date.For the two lot #s, 25161742, 25161829.There were no ncmrs, rework, or deviations documented for the last 2 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported event.For the lot # 25161131.The lot # 25161131 history record review was completed.There were ncmrs , rework, or deviations documented for the lot number shipped to the account.[ncmr #17370- moisture was observed in compressed air tubing in the bioline area of eptfe manufacturing.Condensation in air line(s) may be an indication that the air compressor, bmarm id 00033-5, may not have been producing compressed air with a dew point less than or equal to +7 degrees c as required to satisfy the validation acceptance criteria per mcv00039604 compressed air distribution system oq/pq protocol, rev b, section 7.7.].Based on the dhr/lhr review results, it was determined that there s no relation between the batch manufacturing process and the lot number shipped to the account.

Event Description

Related to 667885.

• Brand Name: HST III SYSTEM (3.8MM)
• 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: 15216864
• MDR Text Key: 297780209
• Report Number: 2242352-2022-00695
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700314
• UDI-Public: 00607567700314
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention