MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER

Model Number 777F8

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

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.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.No actions will be taken at this time.A device history record review was initiated to check whether the device met all specifications upon distribution.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.

Event Description

It was reported that a 777f8 swan-ganz catheter from lot 64854838 had a broken connection upon arrival to the cvicu.Another swan had to be inserted at bedside.This was discovered during use with hemosphere.There was no patient injury.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO 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: 16714166
• MDR Text Key: 313636893
• Report Number: 2015691-2023-12240
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)250123(11)230124(10)64854838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64854838
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2023
• 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