MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR EDWARDS OXIMETRY CENTRAL VENOUS CATHETER (PREVIOUSLY PRESEP OXIMETRY CATHETER); CATHETER, OXIMETER, FIBER-OPTIC

Model Number CVC OXIMETRY UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemothorax (1896)

Event Date 06/16/2022

Event Type  Injury  

Event Description

The following information was obtained through an article published on world journal of clinical cases 2022: massive hemothorax following internal jugular vein catheterization under ultrasound guidance: a case report.As reported, when inserting under ultrasound guidance this 8.5 f edwards oximetry central venous catheter triple lumen in the internal jugular vein (ijv), massive hemothorax in the right patient's hemithorax occurred.When inserting the catheter no blood was aspirated from all three catheter lumens.Then, the device was removed immediately and ijv and surrounding structures above the clavicle were examined using ultrasound but did not detect any problems, such as hematoma.The same insertion procedure was performed again with the same technique with success in aspiration from all three catheter lumens, and the catheter was fixed at a depth of 15 cm.However, after surgical positioning to the right lateral decubitus, the blood pressure suddenly dropped and patient was stabilized with crystalloid.On auscultation of the right lung, there was no apparent reduction in lung sound, the central venous pressure waveform was adequate, and the patient's vital signs were stable; hence, the surgery proceeded.After the initiation of surgery, the blood pressure dropped again and remained unstable until the end of surgery despite sufficient fluid supply and several intravenous administrations of 0.1 mg of phenylephrine.After extubation, the patient complained of slight difficulty in breathing.On auscultation of the lung, the right lung sound was significantly reduced.Ct revealed a massive hemothorax in the right hemithorax.The thoracic surgeon inserted a chest tube and drained 1.6 l of dark reddish blood.Following stabilization of vital signs with fluid replacement, patient was transferred to the intensive care unit after stopping norepinephrine infusion.On the next day, the chest radiography showed no more hemothorax findings.About 50 ml of blood drained through the chest tube on postoperative day (pod) 1, and no blood drained on pod 2.The central venous catheter and chest tube were removed safely on pod 3, and the patient was discharged on pod 7 without any problems.

Manufacturer Narrative

The device was not available for evaluation since it was from a clinical study, so it was discarded.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Since the affected unit was not returned for evaluation, a product non-conformance or device failure could not be confirmed.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.

Manufacturer Narrative

As reported in this article, a large right sided hemothorax was discovered via portable chest xray during this patients post-operative recovery room stay after extubation.The hemothorax was later confirmed via ct however it additionally confirmed that the tip of the central catheter was well placed in the superior vena-cava.The patient required a chest tube drain and intensive care admission for three days.It was reported that an 8.5f edwards central venous oximetry catheter initial insertion into the right internal jugular vein failed with neither venous, arterial blood or air able to be aspirated from any lumens so it was removed.Immediate ultra-sound revealed no tissue trauma or hematoma so the procedure was repeated, this time, successfully.The patient had some hemodynamic instability intraoperatively however hemothorax was not suspected as lung sounds were normal.On insertion of the chest tube post-operatively, it drained 1.6l of blood and another 50mls the following day (post-op day 1).By post-op day 2 drainage had ceased and both chest tube and central venous catheter were removed on post-op day 3 without incident.Patient completed their recovery and was discharged on post op day 7.The article confirms all the inherent risks of central venous catheter placement in the internal jugular vein and notes that in this case the patient had a short neck and was positioned in trendelenburg position during the procedure, increasing the risk of deeper dilator insertion and direct brachiocephalic vein injury.There was no allegation of any deficiency in the edwards central venous catheter or related devices.Risks of central venous catheter insertion in the internal jugular vein are well documented in the literature.Mechanical injuries are rare with about a 1 per cent chance.These may include, but not limited to, vascular (0.8 per cent chance of bleeding), cardiac, pulmonary (0.2 per cent chance of pneumothorax) and placement complications with number of failed attempts accepted as a predictor of complication.Ultrasound guidance may reduce the risk of central venous catheter insertion complications and is is recommended.Additionally, there are recommendations in the instructions for use regarding correct catheter placement confirmation, including continuous pressure monitoring, fluoroscopy (if desired) and a chest xray after insertion.Additionally, there are suitable warnings related to potential complications including vessel perforation, pneumothorax and hemomediastinum amongst others.

• Brand Name: EDWARDS OXIMETRY CENTRAL VENOUS CATHETER (PREVIOUSLY PRESEP OXIMETRY CATHETER)
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16875454
• MDR Text Key: 314630334
• Report Number: 2015691-2023-12771
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: CVC OXIMETRY UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/24/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 57 KG