MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN GANZ BIPOLAR PACING CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number D97120F5

Device Problem No Pacing (3268)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

One swan-ganz catheter was received by our product evaluation laboratory for a full examination.The report of "pacing did not work" was unable to be confirmed.No visible damage or abnormality was observed from catheter body, balloon, windings and returned syringe.Continuity testing was performed on the distal and proximal circuits and there were no open, intermittent, or short conditions observed.The balloon inflated clear and concentric with 1.3 cc air and the balloon remained inflated for 5 min.Without leakage.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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

As reported, during use with this swan-ganz catheter in a patient with bradycardia, the pacing did not work.As per troubleshooting, a new catheter was used that worked perfectly.The decision of changing the catheter was done very fast and this change did not suppose any risk to the patient.There was no allegation of patient injury.The device was available for evaluation.

• Brand Name: SWAN GANZ BIPOLAR PACING CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 15860241
• MDR Text Key: 306453230
• Report Number: 2015691-2022-09481
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K152633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D97120F5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/24/2022
• 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
• Patient Sex: Male