MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CATHETER; CATHETER, FLOW DIRECTED

Model Number 746F8

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that the swan was labeled to have a malfunction with false readings.Multiple attempts have been made for additional information with no response to date.It is unknown if the device was saved for examination or any patient demographics data.Actual occurrence date is unknown.

Manufacturer Narrative

Further follow with the customer indicated that the actual complaint description was not false reading but, that before use the cable to connect the device to the equipment would not recognize the connection to the device and would not calibrate.

Manufacturer Narrative

Further follow up with the customer indicated that the actual complaint description was calibration difficulty not inaccurate values.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10342060
• MDR Text Key: 204779135
• Report Number: 2015691-2020-12786
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 63007148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1