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

Model Number 991F8

Device Problem Material Separation (1562)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/02/2022

Event Type  Injury  

Event Description

It was reported via medwatch report 0039 0111 2022 0018 that a patient became hypotensive with ventricular arrhythmia upon placement of a model 991f8 swan ganz pacing catheter.Transesophageal echocardiogram revealed a large pericardial effusion with tamponade.A pericardial window was performed and injury to the right ventricle was found, which required primary repair with placement of a pericardial drain.When the catheter was removed, the balloon was found sheared off.The device was saved for return.

Manufacturer Narrative

The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review has been initiated and the results will be reported when available.

Manufacturer Narrative

Per additional information received, a central line was placed and then a pulmonary arterial catheter was placed.The patient became bradycardic, hypotensive, and changed heart rhythms, so the pulmonary arterial catheter was removed and changed to a pacing catheter.The reporter alleged when the catheter was retracted to begin repair of the right ventricle, the balloon was what they described as sheared off.Repair of the right ventricle was completed without any issues.The patient was discharged from hospital in stable condition.The suspect catheter has been held at facility per their risk management policy and will not be returned at this time.Without the 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.A device history record review was completed and documented that the device met all specifications upon distribution.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.H3 other text : device not returned.

• Brand Name: SWAN-GANZ FLOW-DIRECTED MULTIPURPOSE CATHETER
• Type of Device: SWAN-GANZ THERMODILUTION A-V
• 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: 15402163
• MDR Text Key: 299692920
• Report Number: 2015691-2022-07825
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00690103151961
• UDI-Public: (01)00690103151961(17)230714(11)210714(10)63881299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: 991F8
• Device Catalogue Number: 991F8
• Device Lot Number: 63881299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male