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

Model Number ICF100

Device Problems Inflation Problem (1310); Unable to Obtain Readings (1516); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

In this case, the root cause of this event cannot be determined with the available information.The subject device was not returned for evaluation; therefore, the complaint cannot be confirmed.The device history record (dhr) could not be reviewed, as the device serial number was not provided.Per the instructions for use (ifu), "visually examine the intraclude device and sterile packaging for evidence of damage (e.G.Rips, tears, etc).If damaged, do not use." 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.If new information becomes available, a supplemental report will be submitted.

Event Description

It was reported that the balloon of an icf100 intraclude device could not be inflated due to inability to read root pressure.Communication between vent and pressure lumens were found to be the cause.A second icf100 was opened.The outcome was reported to be "all good.".

Manufacturer Narrative

H3: evaluation summary: customer report of catheter leakage was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Leakage was observed at the ao root pressure lumen when inflating the ao root infusion lumen.Interlumen leakage was observed between the ao root infusion and ao root pressure lumens.Interlumen leakage was found to occur within the intraclude hub as leakage continued when intraclude shaft was clamped at the hub.Catheter balloon inflated clear and remained inflated for more than 5 min.Without leakage.No other visual damage or other abnormalities were found.The failure was found to be supplier related.The supplier concluded that the leakage found resulted from too less injection molded hub material between the pressure lumen and cardioplegia lumen.In this case, the root cause was determined to be related to a supplier manufacturing defect.The supplier has indicated there will be corrective actions implemented to address the defect.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.

Manufacturer Narrative

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

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8400311
• MDR Text Key: 138416983
• Report Number: 3008500478-2019-00111
• 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,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 05/03/2019; 07/23/2020
• Supplement Dates FDA Received: 05/08/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1