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

Model Number ICF100

Device Problems Restricted Flow rate (1248); Inflation Problem (1310)

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

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

As reported, during use of an intraclude device cardioplegia could not be administered despite route monitoring.It may require catheter exchange or a change in operative strategy.The risk for injury is not remote.The device was not returned for evaluation at this time.In this case, minimal information regarding this event was received and attempts to get additional information have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available or the device is returned for evaluation, a supplemental report will be submitted.

Event Description

Edwards received notification that issues were experienced during the use of an intra-aortic occlusion catheter device.As reported by the perfusionist, cardioplegia could not be administered despite route monitoring responding well.Indication for surgery was excision of a lelf atrial (la) myxoma (tp).The issue was identified during attempted cardioplegia delivery after the intraclude balloon inflation, at first arresting dose.A second attempt at balloon inflation was done.There was significant prolongation of surgical/bypass time (about 30 min).Finally, to arrest the heart, it was converted to chitwood clamp and cardioplegia was delivered through aortic root cannula.The patient was reported to be alive and well.

Manufacturer Narrative

There may be cases in which it is difficult to arrest the heart with administration of cardioplegia.Possible causes include the presence of aortic insufficiency, inadequate cardioplegia dose or delivery pressure, anatomical variations, positioning of catheter or product malfunction impacting the cardioplegia delivery lumen.These are often resolved with routine troubleshooting but occasionally may require the placement of aortic cross clamp, which is a change in operative strategy.These are reportable if associated with a product malfunction, change in operative strategy or significant prolongation of procedural time.In this case, there was a change in operative strategy and significant prolongation of bypass.The device was not returned for evaluation at this time.In this case, minimal information regarding this event was received and attempts to get additional information have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available or the device is returned for evaluation, a supplemental report will be submitted.

Manufacturer Narrative

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.Catheter balloon inflated clear and remained inflated for more than 5 min.Without leakage.As received, catheter shaft outer covering was cracked near the intraclude hub and indentation kinks were observed on the catheter shaft near the intraclude balloon.No other visual damage or other abnormalities were found.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Per the product evaluation, the customer report of intraclude issue was confirmed.Per the engineering evaluation, a supplier manufacturing defect was confirmed.The investigation is ongoing and will documented in the capa.A design, ifu, and labeling defect not confirmed.

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: 8038797
• MDR Text Key: 128044881
• Report Number: 3008500478-2018-00090
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61259626
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/12/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/27/2018; 01/08/2019; 07/23/2020
• Supplement Dates FDA Received: 11/27/2018; 01/11/2019; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention