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 No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

One bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe at gate valve was returned for evaluation.Continuity testing confirmed a full open condition of the proximal circuit.The distal circuit was found to be continuous.A cut down of the catheter body was performed just proximal of the proximal electrode to expose the pacing leadwires.The proximal leadwire was found to be broken at the 3.6 cm area from the catheter tip and both broken edges were not insulated inside the catheter tube.It was found that the proximal circuit was continuous from the broken leadwire to the proximal electrode and from the broken leadwire to the proximal connector pin.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.No visible damage or inconsistency to the windings or returned syringe was observed.Balloon inflation testing was performed using returned syringe with 1.3 cc air by holding the balloon under water.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of ¿unintended ventricular pacing¿ could not be confirmed; however, pacing issue was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients.There are multiple failure modes that may require the exchange of a pacing catheter.Since proper functioning of the pacing catheter depends on the electrical continuity of its electrodes and internal wires, care should be exercised when handling the catheter.Stretching, kinking, or forceful wiping of the catheter may result in damage.After stable pacing has been confirmed, the proximal end of the catheter should be secured to the insertion site to prevent undue movement that could result in tip dislodgment and loss of capture, or catheter migration.Care should be taken not to kink the catheter body when securing it.In this complaint, it could not be determined if procedural factors or device handling may have contributed to the reported 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 unintended ventricular pacing occurred with an edwards pacing catheter during use.The event occurred when the catheter was inserted in the ventricle and stimulation was added to the non-edwards atrium lead.At first, the edwards catheter was inserted into the patient¿s ventricle without problem and a non-edwards atrium and ventricular lead were also inserted for permanent pacemaker implantation.When the stimulation was added to the atrium, ventricular pacing occurred.Ventricular pacing stopped when the edwards catheter was removed.The clinician thought that there was a possibility that the edwards catheter was the cause of ventricular pacing.Patient demographic information requested but unavailable.There were no patient complications reported.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6888787
• MDR Text Key: 88252795
• Report Number: 2015691-2017-03052
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PE074F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• 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