MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PEDIASAT STANDARD CATHETER; PEDIASAT CATHETER

Model Number XT358SJ

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

One triple lumen 5.5f pediasat catheter was returned for evaluation.A non-edwards injection port was attached at the medial lumen hub.Packaging and no other components were returned.Visual examination found that the catheter tip was damaged and fibers were exposed.Adhesive was visible around the fiber bond site at the catheter tip.The damage at the catheter tip was approximately 1.5mm in length.Leakage was observed from the damaged area when the distal lumen was pressurized.Both the medial and proximal lumens were found to be patent and did not leak.Visual examinations were performed under microscope at 10x magnification.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of catheter tip issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this case the customer noticed leakage at the tip of the catheter, which prompted the clinician to exchange the catheter with little delay in the procedure.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 part of this monthly review.

Event Description

It was reported that it was unable to insert a pediasat catheter on the first day of use.The catheter tip was found to be rough.Another catheter was inserted.No further information could be obtained.Patient demographic information for the pediatric patient was not available.No patient complications were reported.

• Brand Name: PEDIASAT STANDARD CATHETER
• Type of Device: PEDIASAT CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500249
• MDR Report Key: 11273760
• MDR Text Key: 232591199
• Report Number: 2015691-2021-00249
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: XT358SJ
• Device Lot Number: 62544662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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