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

Model Number	991F8
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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so the pulmonary arterial catheter was removed and changed to a pacing catheter.The reporter alleged when the catheter was retracted to begin repair of the right ventricle, the balloon was what they described as sheared off.Repair of the right ventricle was completed without any issues.The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
• Common Device Name: 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
• Report Number: 2015691-2022-07825
• Device Sequence Number: 20449088
• Product Code: LDF
• UDI-Device Identifier: 00690103151961
• UDI-Public: (01)00690103151961(17)230714(11)210714(10)63881299
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K803058
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male