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

Model Number SWAN GANZ UNKNOWN

Device Problem Deflation Problem (1149)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported, in recent months with unknown models of swan-ganz catheters, balloon deflation inability events have been experienced in multiple occasions.No further information was available.There was no allegation of patient injury.

Manufacturer Narrative

Investigation of event details and follow up to clarify whether the device is available for evaluation is ongoing.The lot numbers for these devices were 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.

Manufacturer Narrative

As per new information received the issue was always noted before use, no patients were directly involved.Patient demographics unable to be obtained.The event description was therefore updated to: as reported, in recent months with unknown models of swan-ganz catheters and always before use in patient, balloon deflation inability events have been experienced in multiple occasions.There was no allegation of patient injury.Despite due diligent attempts to receive further information regarding this event, no additional information was received from the customer.Additionally, it was further informed that no devices were available for evaluation since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.As part of the manufacturing process, units undergo a balloon inspection and balloon deflation test.Additionally, balloon free deflation time requirements are established for all models.

• Brand Name: SWAN-GANZ CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• 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 ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 16952463
• MDR Text Key: 315833597
• Report Number: 2015691-2023-13069
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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