MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY KIT; CATHETER, OXIMETER, FIBEROPTIC

Model Number X3820ST

Device Problem Break (1069)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received 2 images for review.Image 1 showed a section of guidewire, guidewire advancer and tubing.Blood was visible on the tubing.Image 2 showed the guidewire was broken into halves.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a broken guidewire was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.The suggested insertion procedure section of the ifu advises: ¿d.Insert the desired tip (straight or ¿j¿) of a guidewire into the placed catheter or, if used, the thin-wall needle.Gentle manipulation may be needed to insert the guidewire.The guidewire should never be forced.If difficulty is met during insertion of the guidewire, completely withdraw the guidewire and reattempt insertion.Caution: to avoid possible severing of the guidewire, do not withdraw against the needle bevel.This can result in the need for an additional percutaneous intervention to retrieve the guidewire.Caution: do not withdraw a ptfe-coated guidewire through a metal needle as this may damage the guidewire coating, potentially resulting in an embolism.¿ it is unknown whether user or procedural factors contributed to the stated 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 physician stated the guidewire on a presep catheter broke.The device was exchanged for a catheter from another brand without further issue.There was no patient injury.Patient demographics were requested and not provided.It is unknown if the issue occurred before or during use and no further details are known at this time.The catheter will not be returned for evaluation; however, the customer provided images of the suspect device.

Manufacturer Narrative

Our product evaluation laboratory received one guidewire with holder.The packaging and all other components were not returned.The guidewire was found broken in two pieces at approximately 10.6 inches from the proximal end.No other visible damage was observed from the guidewire.The customer report of an issue with the guidewire was again confirmed, as it had been in on image evaluation.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8481168
• MDR Text Key: 141181914
• Report Number: 2015691-2019-01169
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Model Number: X3820ST
• Device Catalogue Number: X3820ST
• Device Lot Number: 61351099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1