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

Model Number X3820SJD

Device Problem Kinked (1339)

Patient Problem Hematoma (1884)

Event Date 11/29/2017

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.A device history record review was completed and documented that device met all specifications upon distribution.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 developed a hematoma in the neck during the procedure.This hematoma was physiologically significant and was possibly treated.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 j shaped tip of the guidewire was deformed or bent and it was unable to pass the guidewire straight into the blood vessel during insertion.Therefore, the guidewire turned back to the insertion site.The guidewire was inserted in order to exchange the central venous catheter which had been used.It is unknown if the guidewire was inserted to the patient¿s blood vessel directly or if it was inserted through the catheter.Due to this event, the neck was swollen and a hematoma was developed.

Manufacturer Narrative

One guidewire with holder was returned for evaluation.Packaging and all other components were not returned.Damage was found on the j tip area of the returned guidewire.The guidewire coil was kinked or damaged at one location on the j tip, and it was noted that the curved area on the j tip coils were uneven.No other visible damage to the guidewire was observed.Visual examinations were performed under microscope at 10x magnification.Customer report of guidewire issue was confirmed during the evaluation.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY KIT
• Type of Device: PRESEP 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 7140714
• MDR Text Key: 96053745
• Report Number: 2015691-2017-04476
• 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,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2019
• Device Model Number: X3820SJD
• Device Lot Number: 60864978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/10/2018
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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
• Patient Weight: 60