MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC PRODUCT NOT IN LIST - BEATING HEART; CLAMP, VASCULAR

Model Number PRODUCT NOT IN LIST - BEATING HEART

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

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.

Event Description

The hospital reported through heartstring iii advisory panel event about the heartstring iii used for a coronary artery bypass procedure.They mentioned "lately they have been seeing more blood" when using the hs iii system.¿occasionally, but infrequently¿, he feels the seal does not create as good of a hemostatic field as he is used to seeing.He noted this has been occurring ¿maybe in the past 5 years¿ he feels it was less of a problem prior to maybe 5 years ago.He has noted this issue to be related to the level of aortic atherosclerotic disease.Nor has he noted that the patient¿s blood pressure was lower than what he prefers it to be during creation of the proximal anastomosis.He noted ¿it is really not a big deal and does not interfere with his ability to perform the anastomosis¿ but is different than what he remembers comparing use now to 5 years ago.

Manufacturer Narrative

Trackwise # (b)(4).Corrected section; b5 - event description corrected.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.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.

Event Description

Statement from the heartstring iii advisory panel event about the heartstring iii used for a coronary artery bypass procedure.They mentioned "lately they have been seeing more blood" when using the hs iii system.¿occasionally, but infrequently¿, he feels the seal does not create as good of a hemostatic field as he is used to seeing.He noted this has been occurring ¿maybe in the past 5 years¿ he feels it was less of a problem prior to maybe 5 years ago.He has noted this issue to be related to the level of aortic atherosclerotic disease.Nor has he noted that the patient¿s blood pressure was lower than what he prefers it to be during creation of the proximal anastomosis.He noted ¿it is really not a big deal and does not interfere with his ability to perform the anastomosis¿ but is different than what he remembers comparing use now to 5 years ago.

• Brand Name: PRODUCT NOT IN LIST - BEATING HEART
• 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: 13841329
• MDR Text Key: 287558727
• Report Number: 2242352-2022-00257
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - BEATING HEART
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• 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