MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA); CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Failure to Capture (1081)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.

Event Description

It was reported that during use of a swan-ganz pacing catheter, there was no signal and it failed to capture ¿with the pacing wire¿.The pacing box and the cables were replaced but it did not solve the issue.The temporary pacing wire was changed and they were then able to capture and pace.There was no allegation of patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

Our product evaluation laboratory received one model d97120f5 pacing catheter with a 1.3cc monoject syringe.Continuity testing confirmed a full open condition of the proximal circuit.The distal circuit was continuous.The proximal lead wire was found broken approximately 4cm from the catheter tip, and insulation was not present at the broken section.The proximal circuit was continuous from the broken lead wire to the proximal electrode and the broken lead wire to the proximal connector pin.The balloon inflated clear and concentric with 1.3cc of air and remained inflated for 5 timed minutes without leakage.No visible damage or inconsistency was observed from the catheter body, balloon, windings, and returned syringe.The customer report of a pacing issue was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.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.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The following root causes were established as part of a capa generated to further investigate and ensure the applicable actions are taken as required: inadequate process control and lack of procedure or instruction.The following actions are established in the implementation phase of the capa: replace the currently validated bipolar pe0 manual stretching process to an automated stretching process to eliminate variability added by the manual process; clarify the rejected reasons after the continuity test related to open circuit in both electrodes (distal and proximal); and re-layout will promote major area of catheter inside the curved base.In addition, a personnel acknowledgment was given to the manufacturing personnel on 10/17/2019 as part of the complaint evaluation, which is after the complaint 's affected work order manufacturing date of 04/08/2019.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 9112943
• MDR Text Key: 196555958
• Report Number: 2015691-2019-03558
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 62112003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1