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

Model Number ICF100

Device Problem Fluid/Blood Leak (1250)

Patient Problem Ventricular Fibrillation (2130)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to edwards for evaluation.Attempts to retrieve the device is in process.The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the intraclude balloon is not totally occlusive during a procedure, the heart would fill and warm, the operative site may be obscured, and the procedure may need to convert to an open procedure.The cause of the event cannot be determined at this time.A supplemental mdr will be submitted when new information and/or upon completion of the investigation.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 notification that during a robotic mitral + tricuspid valve repair surgery, issues were experienced during use of this intraclude device model icf100.A hole was observed on the cannula.As reported, the issue in the balloon lumen was detected at 45 min after balloon inflation.At that point the surgeon was implanting the annuloplasty ring, 2/3 of the ring were already attached when loss of pressure and lv filling were noticed by the surgeon.Reportedly, an attempt to re-inflate the balloon with additional volume of saline was performed but the balloon started loosing pressure again and occlusion was no longer achieved.The catheter was removed from the endo return cannula and upon inflation surgeon noted a tiny hole between the the low-flow marker and the balloon.As reported, this area of the catheter was in the arch and the surgeon was not working in that area when the issue was observed.The procedure ended under fibrillation arrest.The patient did not suffer any injury/adverse event due to this issue and was noted as to be doing well and discharged.As reported, the intraclude device and its packaging were visually examined prior use and no issues were observed.The hole was not observed during priming of the device but medical team was unsure if this kind of small defect could have been detected during priming.Reportedly, upon insertion of the catheter in the endo return cannula no resistance was noticed and the patient did not have vessels calcification.

Manufacturer Narrative

The device has not been returned to edwards for evaluation.Attempts to retrieve the device is in process.The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures.If the intraclude balloon is not totally occlusive during a procedure, the heart would fill and warm, the operative site may be obscured, and the procedure may need to convert to an open procedure.The cause of the event cannot be determined at this time.A supplemental mdr will be submitted when new information and/or upon completion of the investigation.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 notification that during a robotic mitral + tricuspid valve repair surgery, issues were experienced during use of this intraclude device model icf100.A hole was observed on the cannula.As reported, the issue in the balloon lumen was detected at 45 min after balloon inflation.At that point the surgeon was implanting the annuloplasty ring, 2/3 of the ring were already attached when loss of pressure and lv filling were noticed by the surgeon.Reportedly, an attempt to re-inflate the balloon with additional volume of saline was performed but the balloon started loosing pressure again and occlusion was no longer achieved.The catheter was removed from the endo return cannula and upon inflation surgeon noted a tiny hole between the low-flow marker and the balloon.As reported, this area of the catheter was in the arch and the surgeon was not working in that area when the issue was observed.The procedure ended under fibrillation arrest.The patient did not suffer any injury/adverse event due to this issue and was noted as to be doing well and discharged.As reported, the intraclude device and its packaging were visually examined prior use and no issues were observed.The hole was not observed during priming of the device but medical team was unsure if this kind of small defect could have been detected during priming.Reportedly, upon insertion of the catheter in the endo return cannula no resistance was noticed and the patient did not have vessels calcification.

Manufacturer Narrative

Corrected data: added d4 and h4 expiration and mfg dates that were inadvertently left out of mdr.

Manufacturer Narrative

H3.Device evaluation: device was returned with visible traces of blood.A pinhole was observed on the catheter shaft approximately 0.5cm distal of the low-flow marker.Aortic root pressure lumen was found to be occluded with blood.All other through lumens were found to be patent without any leakage or occlusion.As received, the catheter was observed to have a kink along the shaft at approximately 1cm distal from the hub.Balloon inflated clear and remained inflated without leakage no other visual damage or other abnormalities were found.Videos and photo provided showed leakage distal of the low-flow marker and aligned with lab finding of pin hole.H10.Additional manufacturer narrative: the device was returned to edwards for evaluation.Customer complaint of hole was observed on the cannula was able to be confirmed.Added information to d9, h2, h3.

Manufacturer Narrative

The device history record 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.Per supplier investigation and conclusion, the complaint product was cleaned and inspected from the proximal end to the distal end.Using a microscope, a hole was noticed between the final marker and the distal end.Using a larger magnification and a light illuminating the sample from the bottom, it was determined that the hole was going from the outside to the inside (as can be seen by the shadow on the lower part of the hole).According to the examination of the hole, it is assumed that the hole is caused by an external force which happened most likely during the procedure or when preparing the device.It is not believed that this hole is caused by a manufacturing related issue or when packaging the catheter.This is supported by the fact that the devices are being tested for leakage at the manufacturing site and that a hole like this would easily be found during those tests.The cause of the complaint is assumed to be related to the clinical procedure.The reported complaint is not related to the intraclude.A dhr review was performed and no related non-conformances were found.The complaint is confirmed, but there is no evidence to suggest a manufacturing non-conformance, as evidenced by the customer indicating there was no leakage during priming, which may require multiple syringe aspirations with saline.The leakage in the videos provided is very noticeable, so it is highly unlikely the hole would not be noticed during priming or visual examination.Furthermore, per the supplier conclusion, the devices are tested for leakage at the manufacturing site and a hole like this would easily be found during those tests.Since "the issue in the balloon lumen was detected at 45 min after balloon inflation and attempts to re-inflate the balloon were unsuccessful, the puncture may have occurred sometime during the procedure or possibly during insertion.Regardless, the puncture most likely occurred during customer use/handling after priming.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: VASCULAR CLAMP
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 13061485
• MDR Text Key: 285613258
• Report Number: 2015691-2021-06976
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Model Number: ICF100
• Device Lot Number: 63568099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1