MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774HF75

Device Problems Inflation Problem (1310); No Pressure (2994)

Patient Problems High Blood Pressure/ Hypertension (1908); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

The image in the journal article shows a chest x-ray in an anterior-posterior projection in adequate inspiration.Minimal pleural effusions and no significative lung infiltrates are observed.A central venous catheter, that may correspond to a swan ganz catheter, is located from the right jugular vein down to the right pulmonary artery, passing through the right cardiac chambers.The tip shows a radiopaque structure that may correspond to a knot at this level.Lot or serial number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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.Per the ifu: ¿flexible catheters have been reported to form knots, most often as a result of looping in the right ventricle.Sometimes the knot can be resolved by insertion of a suitable guidewire and manipulation of the catheter under fluoroscopy.If the knot does not include any intracardiac structures, the knot may be gently tightened and the catheter withdrawn through the site of entry.¿ in this case, an additional intervention was required to remove the catheter.Complaint histories for all reported events are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.This article is available online at: http://www.Panafrican-med-journal.Com/content/article/14/137/full/.

Event Description

It was reported that in a journal article titled "intracardiac node of swan-ganz catheter¿ that during use in a (b)(6)-year-old patient who underwent a coronary bypass surgery, a swan-ganz catheter was used to refine hemodynamic monitoring.The pulmonary arterial pressure curve looked normal and confirmed the pulmonary hypertension detected by the preoperative ultrasound, however it was difficult to inflate the balloon making it impossible to measure the pressure in the pulmonary capillaries.Postoperatively, a chest x-ray was taken showing a swan-ganz catheter node at the level of the pulmonary artery which had to be removed by undergoing a cervicotomy surgery under a cervical block.On opening of the right internal jugular vein, a simple, tight node 14mm from the distal end of the catheter was found.The device was not returned for examination.

Manufacturer Narrative

Model and lot number were received.It should also be noted that the article did not state that the complication was caused by a defect in the swan-ganz catheter.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10299161
• MDR Text Key: 200771942
• Report Number: 2015691-2020-12603
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: 774HF75
• Device Lot Number: 59124968
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention