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

Model Number ICF100

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was reported after inserted the icf 100, the balloon was leaking.(initial balloon volume approx.35cc) since the right side of the band was already performed, and in order to prevent the lv from filling with blood, a syringe was used to continuously inflate the balloon so the surgeon could finish with suture placements of the mitral band.A precipitous drop in balloon pressure was noticed when he placed the first suture in the left trigone of the mitral annulus.Surgeon stated that he felt the "pop" with the needle.The balloon pressure prior to rupture was approximately 380mmhg.After rupture the pressure dropped quickly to 70mmhg.There were no patient complications related to the balloon rupture and the case continued without further complications.Post-operative course was unremarkable.Ct scan was done prior to the surgery.

Manufacturer Narrative

H3: customer complaint of "the balloon was leaking" was confirmed.Device was returned with visible traces of blood.Balloon inflated but failed to maintain inflation due to a pin hole leakage.Balloon had a small slit/pin hole approximately 1.5mm in length.All through lumens were found to be patent without any leakage or occlusion.Catheter was observed to have a kink along the shaft at the distal end of the hub.No other visual damages or abnormalities were found.

Manufacturer Narrative

Updated sections: d4 expiration date, g3, g6, h4, h6 type of investigation, investigation findings, and investigation conclusions.Engineering evaluation summary: a dhr review was performed, and no relevant non-conformances were identified.Based on the information available, the complaint is able to be confirmed and the most likely root cause is user error during procedure.Evidence suggests that the root cause of the balloon rupture was a puncture made by the needle during suture placement.An edwards defect has not been confirmed.

• Brand Name: INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; ant 6.1; irvine, CA 92614 ; 9492502731
• MDR Report Key: 15830451
• MDR Text Key: 306506537
• Report Number: 2015691-2022-09372
• 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
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: ICF100
• Device Lot Number: 128264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female