MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE CLAMP, VASCULAR

Model Number ICF100

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation. Evaluation is in progress. As reported while positioning the intraclude device, the atrial wall retractor was lifted and displaced the balloon. The intraclude device was exchanged for an external cross clamp. A definitive root cause cannot be determined. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.

Event Description

Edwards received notification that the balloon of this clamp device was observed to be deformed. The event occurred during a mitral repair surgery done with mis approach. As reported, upon positioning of the device, the atrial wall retractor was lifted which displaced the balloon. The surgical team was not able to have a proper placement and the lv got flooded. It was decided to switch to a chitwood clamp. Upon removal of the catheter, it was tried to inflate the balloon outside of the patient body and it was noticed that the balloon was abnormally severely eccentric, which was not that deformed at first when they tested the balloon in the prepping steps. Patient outcome was noted to be good. As observed by the surgeon, the patient had a particular geometry of the ascending aorta.

Manufacturer Narrative

Additional manufacturer narrative: as per manufacturer evaluation, besides small kink and compression marks and small damages at the end of the strain relief, no deviations were found. The balloon was inflated with 40 ml and showed a more eccentric shape compared to five retention samples of the same lot that were only used for lot release testing in circular shaped tubes of 40 ml and inflated with 40 ml. Manufacturing and balloon lot documentation showed no deviations from process or specifications. The abnormal aorta shape and the knowledge that the polyurethane balloon can change shape over time it is expected that the noticed severe eccentricity has been originated during the clinical case. The complaint is not product related.

Manufacturer Narrative

Device evaluation: customer report of deformed balloon was not confirmed with assessment. Device was returned with visible traces of blood and was examined in the biohazard area of the lab. As received, shaft was kinked near the hub area. Catheter balloon inflated clear and remained inflated for more than 5 min. Without leakage. All through lumens were found to be patent without any leakage or occlusion. No other visual damage, contamination, or other abnormalities were found. Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event. Manufacturing, supplier, design, ifu and labeling defects were not confirmed. Trend is in control. Capa and pra action are not required. Root cause cannot be determined at this time.

Event Description

Edwards received notification that the balloon of this clamp device was observed to be deformed. The event occurred during a mitral repair surgery done with mis approach. As reported, upon positioning of the device, it was lifted the atrial wall retractor which displaced the balloon. The surgical team was not able to have a proper placement and the lv got flooded. Time of inflation was between 5 and 10 minutes. Position of balloon in aorta was above the stj. It was decided to switch to a chitwood clamp. Upon removal of the catheter, it was tried to inflate the balloon outside of the patient body and it was noticed that the balloon was abnormally severely eccentric, which was not that deformed at first when they tested the balloon in the prepping steps. Patient outcome was noted to be good. As observed by the surgeon, the patient had a particular geometry of the ascending aorta.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: INTRACLUDE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8487556
• Report Number: 3008500478-2019-00118
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61704656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No