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 Problems Pacing Problem (1439); No Pacing (3268)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model d97120f5 pacing catheter with a 1.3ml monoject syringe and din adapters.Continuity testing confirmed a full open condition in the distal circuit.The proximal 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 lead wires.The distal lead wire was able to be pulled out and found to be broken or not soldered at the distal electrode.The distal end of the distal lead wire was insulated.The distal circuit was continuous from the broken lead wire to the distal connector pin.The balloon inflated clear and concentric with 1.3ml of air and remained inflated for 5 timed minutes without leakage.No visible damage or defects were observed from the balloon, adaptors, windings or catheter body.The customer report of pacing issues was confirmed on evaluation.It is noted by the manufacturer that the reported event states that ¿pacing was successful after changing the defective wire for a new one¿; however, the reported model d97120f5 does not contain a removable wire.Follow-up with the customer remains ongoing to clarify if the customer meant to state that they replaced the catheter.A device history record review was completed and documented that the device met all specifications upon distribution.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.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 a swan-ganz wire failed to pace during use.The cables and the box were changed but it was still unable to pace.X-ray showed that the wire was in the right ventricle.Pacing was successful after changing the defective wire for a new one.There was no allegation of patient injury.Patient demographics were requested but not provided.

Manufacturer Narrative

Patient demographics were obtained.The patient is an 84-year-old female, weighing 68 kilograms.

Manufacturer Narrative

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 00610
• MDR Report Key: 8932572
• MDR Text Key: 198698728
• Report Number: 2015691-2019-03184
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2021
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 62132790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 68