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

Model Number PE074F5

Device Problem Pacing Problem (1439)

Patient Problem Cardiac Perforation (2513)

Event Date 08/13/2020

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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.Cases of myocardial perforation associated with the use of temporary trans-venous pacing catheters have been reported.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 pacing was not observed after insertion of a swan-ganz pacing thermodilution (td) and that the patient experienced cardiac perforation during use.The patient was treated immediately.Patient demographic information requested but unavailable.Follow-up on patient outcome and current status are underway.

Manufacturer Narrative

Additional information was reported that before pacemaker implantation, the pacing catheter was connected to the lead but was unable to pace.When the catheter was checked under radiography, cardiac ventricular perforation was found.Since the patient¿s vital signs were stable, the operation was continued.After pacemaker implantation was completed, the customer tried to extract the catheter with extracardiac backup.Cardiac tamponade was not caused, and there was no need of thoracotomy procedure.After the catheter was extracted, the patient¿s vital signs were stable.The patient was admitted to the icu for follow-up.The patient¿s vital signs were stable, and pericardial fluid was not increased apparently, so the patient was moved out of icu.The patient originally had atrioventricular block.Patient sex is female and age 80.The severity was determined as patient needed to stay at hospital for medical treatment and/or needed longer stay at hospital.Patient status was defined as patient condition is well.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC 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: 10452074
• MDR Text Key: 204523130
• Report Number: 2015691-2020-13301
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1