MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY SET; PRESEP CATHETER

Model Number X3820SJD

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

One triple lumen presep catheter was returned for evaluation.As received suture loop and box clamp were attached on the catheter body at 15-17cm marker area.Non-edwards injection ports were attached at lumen hubs.Packaging and all other components were not returned.Visual examination found that the soft tip was completely broken from the catheter body.No visible damage was observed at the catheter tip bond area; however, the optic fibers were exposed and found to be broken inside the catheter body.One fiber was broken at the 18cm marker area and the second fiber was broken at the area between the backform and the 20cm marker area.Both fibers were not straight and appeared to be rippled and kinked at the broken area.Edges of the broken catheter sites appeared to match up.One of the fibers still transmitted light and the light was visible inside the catheter at the area between the backform and 20cm marker area and the other fiber did not transmit light.Invitro calibration was performed to see how the monitor would respond to the catheter condition, and the catheter was found to fail invitro calibration.Leak test was performed to the retuned sample from hubs to ports, and no leakage was observed.Optic connector was opened for further evaluation.Dry blood was visible inside the connector and strain relief area, but fibers remained coiled and no damage was observed at bond area between fibers and connector.Visual examinations were performed under microscope at 10x magnification.The lot numbers provided were reported as a possible lot numbers; lot 62780389 (manufactured date: 09-dec-2019, expiration date: 02-dec-2021), lot 62780390 (manufactured date: 09-dec-2019, expiration date: 03-dec-021), lot 62780391 (manufactured date: 15-dec-2019, expiration date: 08-dec-2021), lot 62859072 (manufactured date: 20-dec-2019, expiration date: 15-dec-2021), lot 62992674 (manufactured date: 02-mar-2020, expiration date: 25-feb-2022).A device history record review was completed and documented that device met all specifications upon distribution.Customer report of ¿catheter tip was separated from the catheter body¿ 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 instance, the catheter tip separated from the catheter body, but it remained attached to the optic fibers.The tip could have separated from the optic fibers, which are not designed to support the catheter tip, and embolized in the patient.It is unknown if procedural or use factors contributed to this 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.

Event Description

It was reported that the presep catheter tip separated from the catheter body during use.On (b)(6) 2020 the catheter was inserted to the patient and cardiac surgery was performed.After the surgery, the patient was transferred to the icu.On (b)(6) 2020 the catheter body was able to be removed from the patient without issue but the optical fiber was found to be exposed from the catheter insertion site.Therefore, the customer pulled out the optical fiber together with the catheter tip which was still connected to the optical fiber.The customer checked the x-rays which had been taken every day during use, and the x-ray taken on (b)(6) 2020 showed that the catheter tip was separated from the catheter body.Additional information was obtained that around 7-8 centimeters-long optic fibers were exposed from the catheter insertion site at the catheter removal.The anesthesiologist speculated from the x-rays that the catheter tip was firstly separated from the catheter body and the separated tip got stuck somewhere in the patient body at removal, and as a result, the optic fibers were broken.Scvo2 was no longer showing values and it is unknown if the user stopped watching this parameter or the catheter could not measure due to broken optic fibers.There was no resistance felt when removing the catheter.The customer did not clamp the catheter body with forceps.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

Additional information was received regarding this case.It was noted that on (b)(6) 2020 the 9:00am chest x-ray that was taken was normal.That same morning the patient was defibrillated 3 times.At 12:00, scvo2 readings were not noted on the monitor.It should be noted that the fiber optic of the catheter is made entirely of plastic and cannot conduct any electrical current.Therefore, the catheter should not be affected by defibrillation.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 10652402
• MDR Text Key: 213199469
• Report Number: 2015691-2020-13886
• 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
• Report Date: 09/23/2020

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: 12/02/2021
• Device Model Number: X3820SJD
• Device Lot Number: 62780389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1