MAUDE Adverse Event Report: EDWARDS LIFESCIENCE IRVINE; CATHETER, OXIMETRY, FIBER-OPTIC

Model Number XT358SJ

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.The lot number was not provided thus a device history record was not reviewed.

Event Description

It was reported that medication leakage was observed from the backform on the first day of use during a pediatric cardiac surgery.The catheter was removed from the pediatric patient after the issue was noted.No change in vital signs, no injury occurred and no additional treatment was required due to medication leakage.The details of leaked medication could not be obtained.Patient demographic information was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The reported event of leakage was observed from the backform was confirmed.As received into lab, catheter tip was found damaged, approximately 0.5mm in length, during visual examination.Damaged edges were not able to match up.Leakage was detected from backform to catheter body junction when distal lumen was pressurized.It was not able to perform leak test to proximal lumen since the lumen was occluded with blood.The blood could not be removed during evaluation.No leakage or occlusion was observed in medial lumen.Backform sleeve was removed for further evaluation.No visible damage was observed on catheter body under the backform sleeve.No other visible inconsistency was observed from the returned catheter.Engineering task assigned to manufacturing site for further investigation.

Manufacturer Narrative

Our product evaluation lab received one model xt358sj oximetry catheter.The customer report of leakage was observed from the backform was confirmed.As received into lab, catheter tip was found damaged, approximately 0.5mm in length, during visual examination.Damaged edges were not able to match up.Leakage was detected from backform to catheter body junction when distal lumen was pressurized.It was not able to perform leak test to proximal lumen since the lumen was occluded with blood.The blood could not be removed during evaluation.No leakage or occlusion was observed in medial lumen.Backform sleeve was removed for further evaluation.No visible damage was observed on catheter body under the backform sleeve.No other visible inconsistency was observed from the returned catheter.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing/design defect and no corrective actions will be taken at this time.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.The lot number was not provided thus a device history record was not reviewed.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.

• Type of Device: CATHETER, OXIMETRY, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCE IRVINE; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 18222542
• MDR Text Key: 329233495
• Report Number: 2015691-2023-17755
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: XT358SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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