MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PUERTO RICO SWAN GANZ CCOMBO; SWAN GANZ CATHETERS

Model Number 774F75

Device Problem Incorrect Measurement (1383)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for examination since it was discarded.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.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 in patient with this swan ganz catheter, the right ventricular pressure value was incorrect.The value displayed was 60 mmhg when the value expected was 100 mmhg.No further information was available.There was no allegation of patient injury.Patient demographics were not available.The device was not available for evaluation since it was discarded.

• Brand Name: SWAN GANZ CCOMBO
• Type of Device: SWAN GANZ CATHETERS
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PUERTO RICO; state rd indus pk 402 km 1.4; anasco 00610 ; * 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 12488737
• MDR Text Key: 271929196
• Report Number: 2015691-2021-05225
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63228212
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2020
• 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