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

Model Number ICF100

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

Patient Problem Vascular Dissection (3160)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: udi number: (b)(4).The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.There is proof of this mandatory recall was acknowledged by the facility.Reportedly, the surgeon was aware of the recall, and the patient was aware of the recall prior to its planned intraoperative use; an informed consent was obtained.The femoral dissection was attributed to the use of a non-edwards femoral sheath, without a device malfunction of the icf-100.In the current recall, femoral dissections were not a condition of an icf-100 malfunction.The use of the icf-100 holds potential for a malfunction that could result in other serious injuries or death, although in this case, no malfunction was alleged/detected.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that upon inflation of an intra-aortic occlusion device, the surgeon noted a femoral retrograde dissection and the balloon was immediately deflated and cardiopulmonary bypass was discontinued.The (b)(6) female patient was scheduled for robotic mitral valve repair and maze procedure (redo chest from previous asd closure).Edwards later learned that a non-edwards femoral sheath was used in conjunction with the intra-aortic occlusion device.The surgeon confirmed that the intra-aortic occlusion device did not cause or contribute to the femoral dissection.As reported, on pod #1, the patient was extubated and doing well.Surgeon reported the dissection was not caused by the intra-aortic occlusion device.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9690055
• MDR Text Key: 178745793
• Report Number: 3008500478-2020-00187
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K163693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 62087517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR