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

Model Number SWAN GANZ UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Perforation (2513)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation, although multiple attempts for additional have been made.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.It is not known if some procedural factors may have contributed to the event.When/if additional details come available a supplemental report will be sent.Lot number was not provided; therefore, review of the manufacturing records could not be completed.Perforation/damage may occur as a result of over-wedging a pulmonary artery catheter or forcing the advancement of the catheter against resistance.In many cases the patients' blood vessels or cardiac structures may be diseased and therefore weakened.Any perforation may cause significant bleeding/ injury.In this case, there is no further information from the reporter on the details of this event.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

It was reported that right ventricular perforation occurred during coronary artery bypass graft (cabg) case.Multiple attempts for additional information have been unsuccessful to date.

• Brand Name: SWAN-GANZ CATHETER
• Type of Device: SWAN-GANZ CATHETER UNKNOWN
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 11408206
• MDR Text Key: 234738150
• Report Number: 2015691-2021-01650
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• 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
• Patient Outcome(s): Other