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

Model Number XT245SJ

Device Problem Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

One double lumen oximetry pediasat catheter was returned for evaluation.Customer report of catheter insertion issue could not be confirmed during evaluation; however, a general examination was performed to the returned sample, and the distal end of the backform was found to be slightly deformed.No other visible damage to the returned catheter was observed during visual examination.A lab guidewire was passed hub to tip and tip to hub of returned catheter without problem.Blood could not be fully removed from the proximal lumen.The distal lumen was found to be patent and did not leak.The catheter was sent for further dimensional evaluation.Visual examinations were performed under microscope at 10x magnification.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.A supplemental report will be sent with the dimensional evaluation results.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 patient required a new stick during the procedure to insert a new catheter.It is unknown whether user or procedural factors contributed to the stated event nor were there any patient complications reported.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 the pediasat catheter could not be inserted in a pediatric patient during use.The customer attempted to insert the catheter after dilator insertion but the catheter could not be inserted.The catheter insertion angle was changed but the problem was not solved.A new insertion site was made at the opposite side of the patient but it was unable to insert the second pediasat catheter.The second catheter was exchanged for a non-edwards central venous catheter and this catheter was able to be inserted.It is unknown if a new insertion site was required for the non-edwards central venous catheter.The demographic information for the patient was requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

One double lumen oximetry pediasat catheter was returned for further dimensional evaluation.The outer diameter of the catheter body was measured and found to be within specification at 0.0603".An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PEDIASAT OXIMETRY CATHETER
• Type of Device: PEDIASAT CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8140268
• MDR Text Key: 130343982
• Report Number: 2015691-2018-05129
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K053609
• 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: 11/16/2018

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 Model Number: XT245SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 07/23/2020
• Supplement Dates FDA Received: 01/07/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1