MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PULMONARY ARTERY CATHETER, THERMAL DILUTION; SWAN-GANZ THERMODILUTION CATHETER

Model Number 141F7

Device Problem Deflation Problem (1149)

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

Event Date 10/31/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation due to it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.A review of the manufacturing records indicated that the product met specifications upon release.It is unknown if user or procedural factors may have contributed to this event.Based on further investigation conducted by engineers at the manufacturing site, a root cause could not be determined.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, while trying to insert this swan-ganz catheter, the catheter did not advance.Therefore, the syringe was detached from the gate valve and balloon was deflated.Then, the catheter was tested and found that the balloon did not inflate concentrically and residual air remained after deflation.The issue was solved replacing the catheter.There was no allegation of patient injury.The device was not available for evaluation as it was discarded at the hospital.

• Brand Name: PULMONARY ARTERY CATHETER, THERMAL DILUTION
• Type of Device: SWAN-GANZ THERMODILUTION CATHETER
• Manufacturer (Section D): 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: 12859386
• MDR Text Key: 285481397
• Report Number: 2015691-2021-06458
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: 141F7
• Device Catalogue Number: 141F7
• Device Lot Number: 63731663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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 Age: 41 YR
• Patient Sex: Female