MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)

Model Number PEK074F5

Device Problem Difficult to Insert (1316)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the swan ganz pacing catheter got stuck inside the introducer and the catheter could not be placed on the first day of use.The affected product was a kit, and the customer it was unknown if the introducer or the catheter had a defect so the customer removed both resulting in a new insertion site to insert the new catheter.When the catheter was replaced, the problem was solved.Patient sex was female but other patient demographic information was unavailable.There were no patient complications reported.

Manufacturer Narrative

One bipolar pacing catheter and 5fr peel away introducer was returned for evaluation.Two non-edwards guidewires, non-edwards contamination shield, non-edwards syringe and non-edwards connectors were returned with the catheter.During evaluation the catheter became stuck at 2.3 cm when inserted into a lab 5 fr introflex introducer.It was able to insert the catheter without resistance into returned 5 fr peel away introducer.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.No visible damage to the catheter body, balloon windings or returned introducer was observed.Balloon inflation test was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examination was performed under microscope at 20x magnification and with the unaided eye.The lot number was obtained and a device history record review was completed and documented that the device met all specifications upon distribution.Customer report of catheter insertion issue was confirmed.The catheter was sent for further od measurement testing.A supplemental report will be sent with the evaluation results.

Manufacturer Narrative

Further outer diameter (od) measurement testing was performed and the catheter od was found to be out of specification.The catheter maximum od was located at around 3 cm from the catheter tip, measuring 0.0748".Catheter body tube outer diameter is 0.070" maximum.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 instance, the patient required a new stick during the procedure to insert a new access device and catheter, this is a reportable event.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.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER AND KIT (FOR SUPERIOR VENA CAVA INSERTION)
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11394614
• MDR Text Key: 245128597
• Report Number: 2015691-2021-01614
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: PEK074F5
• Device Lot Number: 63340099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1