MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE; CLAMP, VASCULAR

Model Number ICF100

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported that upon inflation of the icf100 intraclude device antegrade cardioplegia was delivered and it was observed that there was no balloon pressure and root pressure was equal to the systemic pressures.Negative pressure was drawn on the balloon syringe and blood was observed upon return.The icf100 was removed and another was prepped and introduced.The procedure moved forward without any issues.Upon inspection of the subject icf100 balloon there was a separation within the lumen of the catheter while pulling back the slack.The balloon was noted to be fully in tact, but upon inflation fluid would come of the green stopcock ports.When the green stopcock port was turned off, fluid would come out of the red stopcock port.

Manufacturer Narrative

H10: additional manufacturer narrative: updated: b4, d4, g3, g6, h2, h4, h6 the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There is no evidence to suggest an edwards manufacturing defect.The subject device was not returned for evaluation and no images, operative report, or medical records were provided.Information was provided, however, regarding the mishandling of the device, including attempting to remove the device while the rotating hemostasis valve remained tightened.Thus, the root cause of the reported event is likely use error.An edwards defect has not been confirmed.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17171938
• MDR Text Key: 317639430
• Report Number: 2015691-2023-14061
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/02/2023
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2023
• Date Device Manufactured: 09/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other