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

Model Number 131F7P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemoptysis (1887)

Event Date 09/27/2022

Event Type  Injury  

Event Description

It was reported via notification from abbott that during one of their cardiomems implant procedure, the patient experienced hemoptysis.An edwards lifesciences brand swan ganz catheter, model 131f7p, lot 64442507 was reported to have been used during the implant, and it is unknown if either of the devices contributed to or caused the hemoptysis.The hemoptysis occurred after the procedure had been completed with no complications to report.The patient was intubated and placed in the icu to monitor the hemoptysis.The bleeding stopped without any further intervention and the patient was discharged on (b)(6) 2022.The physician was unable to confirm the cause of the hemoptysis.

Manufacturer Narrative

The abbott representative did not provide contact information for the customer and has not responded to attempts to obtain that information in order to arrange for return of the suspect device for evaluation.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Complaint histories for all reported events are reviewed against trending control limits and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15719881
• MDR Text Key: 302920714
• Report Number: 2015691-2022-08979
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 131F7P
• Device Catalogue Number: 131F7P
• Device Lot Number: 64442507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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): Hospitalization