MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE; CLAMP, VASCULAR

Model Number ICF100

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.As reported, during prep of the balloon, leaking was observed at the strain relief zone.A definitive root cause cannot be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that issues were experienced during the use of a catheter.As reported, upon prepping the balloon before utilization, the scrub nurse noted that while inflating the balloon through the balloon lumen, fluid was leaking at the strain relief zone.They decided not to use the device and opened a new one for the case.The user is very experienced with the device (over 50 cases/year).There were no adverse events for the patient.

Manufacturer Narrative

Device evaluation: customer complaint of leakage from mid-shaft area was confirmed.As received, the device started leaking at the mid-shaft connection area when inflating the balloon inflation lumen (see figure 2).All other through lumens were found to be patent without any leakage or occlusion.No other visual damage or other abnormalities were found.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.

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: 8312928
• MDR Text Key: 136142993
• Report Number: 3008500478-2019-00105
• 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
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: ICF100
• Device Catalogue Number: ICF100
• Device Lot Number: 61184964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1