MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER

Model Number 777F8

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

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

The following information was obtained from a doctor regarding a case presented at the 41st annual meeting of the japan society for clinical anesthesia in 2021.It was reported that a 777f8 swan-ganz catheter was erroneously advanced and placed into the patient during use.During s mitral valve replacement (mvr), the customer noticed that the swan-ganz catheter was monitoring the left ventricle pressure (lvp) while pulmonary artery pressure (pap) was supposedly monitored.Echography confirmed that the catheter perforated the interventricular septum and was monitoring the lvp instead of pap.The customer suspected that the perforation occurred since the cardiac surgeon advanced the catheter without inflating the balloon.No additional intervention was required from the perforation.According to the anesthetist, a small, perforated hole in the interventricular septum would heal without any intervention.The patient outcome was reported as recovered.The device was discarded at the hospital.

Manufacturer Narrative

The device was discarded at the facility; therefore, product investigations are unable to be conducted.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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.Perforation/damage may occur as a result of over-wedging a pulmonary artery catheter or forcing the advancement of the catheter against resistance.In many cases the patients' blood vessels or cardiac structures may be diseased and therefore weakened.Any perforation may cause significant bleeding/ injury.Strict adherence to these instructions and awareness of risks reduces the incidence of complications, as referenced in the ifu complications section.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.Device discarded.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V
• 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: jonathan diaz ; 1 edwards way; irvine, CA 92614 ; 9492507258
• MDR Report Key: 16892377
• MDR Text Key: 314807924
• Report Number: 2015691-2023-12858
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2023

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: 777F8
• Device Catalogue Number: 777F8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/08/2023
• 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): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 32 KG