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 12/10/2019

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.Udi # (b)(4).

Event Description

It was reported that a swan-ganz pacing wire did not capture to pace.The specific details were not provided pending ongoing follow-up.There was no allegation of patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

Per additional follow-up with the customer, it was relayed that their process when a pacer fails to capture is to change the pacer cable, red pins, and the pacemaker.If capture is still not achieved, a new pacemaker catheter (with a different lot number) is inserted.Capture is achieved following all these steps.There was no patient injury in this instance.Our product evaluation laboratory received one model d97120f5 catheter with a monoject limited volume syringe and non-edwards contamination shield.Continuity testing confirmed a full open condition of the proximal and the distal circuits at the tip of the catheter.Cut down on the catheter body found the proximal lead wire was broken approximately 3cm proximal from the distal tip.The distal lead wire was found to be broken or detached near the distal electrode.The balloon inflated clear and concentric 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 failure 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, such as a break to the electrode wire circuitry.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.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.Care should be taken not to kink the catheter body when securing it.Additionally, the preparation section of the ifu indicates: ¿1.For the vip bipolar pacing catheter, flush the infusion lumen with a sterile solution to assure patency and to remove air.If the infusion lumen is not to be used immediately, a sterile heparinized d5w or saline solution should be used intermittently to ensure patency.2.For all bipolar pacing catheters, check balloon integrity.Inflate to the recommended volume and check for major asymmetry and leaks by submerging in sterile saline or water.¿ 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

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: 9507377
• MDR Text Key: 188679335
• Report Number: 2015691-2019-04832
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 62703184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1