MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING; SWAN-GANZ CATHETER

Model Number D97130F5

Device Problem Pacing Problem (1439)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

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.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.

Event Description

As reported, during use in patient of this swan-ganz catheter, there was difficulty to sense pressure and to pace.The issue was solved by using another catheter.No further information regarding the type of patient and demographics was available.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

One swan-ganz catheter model d97130f5 catheter with 1.3cc syringe were received by our product evaluation laboratory for a full examination.The report of pacing issue was confirmed.Continuity testing confirmed a full open condition in 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 lead wires.Insulation was not present at the broken section.It was found that the proximal circuit was continuous from broken lead wire to proximal connector pin and from broken lead wire to proximal electrode.The balloon inflated clear and concentric with 1.3 cc air and remained inflated for 5 minutes without leakage.No visible damage was observed from the balloon, windings, catheter body, and returned syringe.Note that the swan-ganz bipolar pacing catheters are designed for temporary pacing, catheter does not have pressure sensing.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

Based on engineering investigation, corrective actions have been implemented to cover the condition of broken leadwire proximal pacing catheter for bipolar and pacing product model.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.

• Brand Name: SWAN-GANZ BIPOLAR PACING
• Type of Device: SWAN-GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12524726
• MDR Text Key: 273114983
• Report Number: 2015691-2021-05319
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97130F5
• Device Catalogue Number: D97130F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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