MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

Model Number PE075F5

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.A device history record review was completed and documented that device met all specifications upon distribution.No actions will be taken at this time.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.All invasive procedures inherently involve some patient risks.The physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are described in the literature.Perforation or damage to vessels or cardiac structures 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.In this case the patient was an (b)(6) female with a history of aortic stenosis.Careful repositioning and withdrawal of the catheter under fluoroscopic control is recommended.It is unknown if user or procedural factors may have contributed to this 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 an (b)(6) female patient experienced perforation of the right ventricle with a swan ganz pacing catheter during a tavr procedure.Tavr procedure was successfully completed.However, after removal of the catheter the patient¿s blood pressure suddenly decreased to 70¿s mmhg while preparing the patient to leave the operating room.Pericardial effusion was detected by tee (transesophageal echocardiography) and pericardial drainage was initiated.It was confirmed that the volume of bleeding had not increased after about 30 minutes of drainage.Then, the operation was completed.The patient status was defined as patient is under observation at this time.

Manufacturer Narrative

Additional information regarding the patient condition was obtained on (b)(6) 2019 and the patient was determined as recovered and discharged from the hospital.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION
• Type of Device: PACING CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8605972
• MDR Text Key: 144941238
• Report Number: 2015691-2019-01714
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: PE075F5
• Device Lot Number: 61809286
• 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): Life Threatening; Required Intervention