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

Model Number PE074F5

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Cardiac Perforation (2513)

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 bipolar pacing 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 right ventricular perforation occurred during use with a swan-ganz bipolar pacing catheter.It is unknown if the event occurred during the insertion procedure or while the catheter was placed in patient body.Follow-up on patient outcome and current status are underway.Patient demographic information requested but unavailable.

Manufacturer Narrative

Additional information was received regarding this case.The catheter was used for temporary pacing.It was noted that on (b)(6) 2020 the catheter was used for sick sinus syndrome.On (b)(6) 2020 right ventricular perforation was suspected from radiograph and on (b)(6) 2020 the chest was opened and temporary pacemaker was removed.On (b)(6) 2020 the patient was discharged from the hospital.The customer commented that the cardiac muscle of right ventricular was perforated, and the catheter was placed in the fat tissue.The patient originally had chronic kidney disease and diabetes.Patient demographic information was obtained.The severity is serious since the event resulted in extension of hospitalization for medical treatment and had a risk to result in death and other harms.The patient condition is well.The causality between the device and the event was reported as unknown.On january 28, 2021 additional information was reported that right ventricular perforation seemed to have occurred while the catheter was placed in the patient body, not during the operation.The lot number was obtained and a device history record review was completed and documented that device met all specifications upon distribution.

• 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: 11248037
• MDR Text Key: 229347097
• Report Number: 2015691-2021-01048
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: PE074F5
• Device Lot Number: 63412892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 80 YR
• Patient Weight: 51