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

Model Number PRODUCT NOT IN LIST - BEATING HEART

Device Problems Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The hospital reported through heartstring iii advisory panel event that the heartstring iii used for a coronary artery bypass procedure, "loading device has gone awry".¿occasionally, likely due to user error¿ the seal fails to load.It doesn't happen often but when it does it always results in the ¿seal hanging out of the end of the delivery tube and the tether still in the tube¿ if this occurs dr.Cai will then ¿hand-roll the seal and load it into the delivery tube¿ he is then able to use the hs seal without incidence.He has never recorded this as a product failure because he relates it to an inexperienced person loading the hs and is able to salvage the seal without issue or harm to the patient.

Manufacturer Narrative

Trackwise (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).Corrected section: b5 - event description corrected; h6 - device problem code changed from "adverse event without identified device" to "fitting problem." communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.

Event Description

Statement from the heartstring iii advisory panel event that the heartstring iii used for a coronary artery bypass procedure, "loading device has gone awry".¿occasionally, likely due to user error¿ the seal fails to load.It does not happen often but when it does it always results in the ¿seal hanging out of the end of the delivery tube and the tether still in the tube¿ if this occurs dr.Cai will then ¿hand-roll the seal and load it into the delivery tube¿.He is then able to use the hs seal without incidence.He has never recorded this as a product failure because he relates it to an inexperienced person loading the hs and is able to salvage the seal without issue or harm to the patient.

• 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: 13841328
• MDR Text Key: 287581325
• Report Number: 2242352-2022-00258
• 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: 04/14/2022

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?: No
• 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: 04/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.