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

Model Number ICF100

Device Problems Component Incompatible (1108); Fluid/Blood Leak (1250); No Pressure (2994)

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

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

As reported, during use of the intra-aortic occlusion catheter, when the vent was turned on the pressure dropped to zero.This resulted in the need to exchange the device.The device is expected for return and evaluation but has not been received at this time.A supplemental report will be submitted upon receiving new information.See related mdr 3008500478-2019-00101.

Event Description

It was reported that during use of an intra-aortic occlusion catheter, the vent was turned and the pressure dropped to zero.The intra-aortic occlusion catheter was removed and a second intra-aortic occlusion catheter was used.This second intra-aortic occlusion catheter also displayed a pressure of zero when the vent was turned on.The surgeon believes there is interaction between the 2 of the lumens causing this to happen.This second occlusion catheter was removed and replaced with a third.This third intra-aortic occlusion catheter worked appropriately and both the patient and the procedure outcome went well.

Manufacturer Narrative

Device was returned with visible traces of blood and was examined in the biohazard area of the lab.No pressure monitoring device was returned with product.As received, the ao root pressure line was occluded with blood and unable to be flushed through.All other through lumens were found to be patent without any leakage or occlusion.Catheter balloon inflated clear and remained inflated for more than 5 min.Without leakage.No other visual damage, contamination, or other abnormalities were found.Per the product evaluation, the customer complaint reported of interlumen leakage issue was unable to be confirmed.Per the engineering evaluation, a manufacturing, design, supplier, ifu, and labeling defect was not confirmed.The trend was reviewed and found to be in control.The root cause cannot be determined at this time.The device history record (dhr) was reviewed and showed that there were no related non-routine ncrs.No further action is required.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INTRACLUDE
• Type of Device: INTRA-AORTIC OCCLUSION CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8246492
• MDR Text Key: 133209845
• Report Number: 3008500478-2019-00102
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K132175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61713211
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1