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

Model Number 777F8

Device Problem Component Misassembled (4004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

One 777f8 catheter was returned for examination.The reported event of, "ports are backward" was confirmed.When passing a stylet wire through the distal hub extension, the wire exited the proximal infusion port.When passing the stylet wire through the proximal infusion hub extension, the wire exited the distal port.When passing a style wire through the proximal injectate port extension, the wire appropriately exited the proximal injectate port.It was found, the distal lumen extension tube was assembled to the proximal infusion lumen while the proximal infusion extension tube was assembled to the distal lumen inside the back-form.The extension tubes were assembled incorrectly.The balloon inflated clear and concentric, and did not leak.No other visible damage, or abnormality was observed from the catheter.Our manufacturing records document that this unit was observed to meet all specifications prior to its release.A capa investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.This non-conformance involves swan ganz catheters with incorrect extension tube assembly.If the extension tubes are assembled incorrectly, the clinician may note reverse pa and cvp pressure values, and waveforms.It is possible for unintended treatment due to inaccurate values if the reversal in waveforms is not noticed.Clinicians are highly trained to recognize appropriate heart pressures and waveforms, which are also used to guide the clinician in correct placement of the swan-ganz catheter.In addition, it is standard practice for the clinician to examine and prep the catheter per back-form instructions before placement in the patient by flushing the lumens with sterile salient or dextrose solution.If needed, the catheter may be exchanged for another with minimal delay in monitoring.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.Complaint data was reviewed for the last 5 years, and this is the only complaint where the extension tubes were incorrectly assembled.Udi number (b)(4).

Event Description

It was reported that before use on a patient undergoing a heart catheterization, the clinicians observed during their routine catheter prep and flush, that the yellow and white extension ports of the swan ganz catheter were reversed.To ensure the finding, two cath lab clinicians flushed the hubs multiple times to confirm this, and therefore, the catheter was not used in the patient.Another catheter was obtained, and inserted.No patient complications were reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; ansco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492502904
• MDR Report Key: 10713141
• MDR Text Key: 212466896
• Report Number: 2015691-2020-14063
• Device Sequence Number: 1
• Product Code: DQE
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2020

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 Expiration Date: 06/19/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63228219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2020
• 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