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

Model Number 931F75

Device Problem Material Rupture (1546)

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

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

The swan ganz catheter involved in this case was received by our product evaluation laboratory for a full evaluation.During visual inspection balloon was found ruptured at the central area.The balloon edges did not match at the ruptured region.All through lumens were patent without any leakage or occlusion.Engineering evaluation will be completed to consider any potential factors that may have contributed to this complaint and a supplemental report will be sent with the investigation result.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 testing this swan ganz catheter, the balloon burst.There was no allegation of patient injury.The device was available for evaluation.

Manufacturer Narrative

Further investigation was completed by the engineers in the manufacturing site.The manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met and inspections passed successfully.Additionally, as part of the manufacturing process, the units go through a balloon inflation and visual inspection.Based on the available information there is no evidence that supports or confirms the failure mode is associated to a manufacturing or design defect.

• Brand Name: SWAN GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 17764376
• MDR Text Key: 323602631
• Report Number: 2015691-2023-16006
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 931F75
• Device Lot Number: 64890640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1