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

Model Number 774F75

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

As reported, during use in patient with this swan-ganz (sg) catheter (b)(6), there were difficulties positioning the catheter in the pulmonary artery.The difficulty was found sliding it into the introducer, both directions, insertion and removal.The swan-ganz had been verified previously.Finally, the catheterization made it possible to obtain curves of the right ventricle (rv).Then, after progressing to the pulmonary artery and inflating the balloon, it was not possible to obtain the pulmonary artery line curve, systematically returned to the rv.Several attempts removing and reinserting the sg catheter were made but obtaining pulmonary artery pressure (pap) was not achieved.When the sg was removed, it was noted a rupture of the distal balloon.Then, the device was replaced by a new unit (b)(6).The replacement swan-ganz was difficult to slide into the introducer (8.5f for sg 7.5 f), when inserting and retracting, especially between 20 and 30 cm.After several attempts, it was completely impossible, in the 30 cm zone, at a bulge located distal to the zebra zone (thermal filament) when it was still in the introducer.Finally, there was an obligation to remove the sg catheter and introducer at the same time.There was no allegation of patient injury.The devices were available for evaluation.

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.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.

Manufacturer Narrative

The swan ganz catheter was received for a full evaluation.The report of resistance with the introducer was unable to be confirmed.As received no visible damage was observed from catheter.Catheter outer diameter was within specification.Non-ew introducer was returned.It was able to insert the catheter without resistance into lab 8.5f introducer as per ifu recommended introducer.The balloon inflated clear, concentric and remained inflated for 5 min without leakage.All through lumens were patent without any leakage or occlusion.No visible damage was observed form catheter body and balloon.The manufacturing records were reviewed for the lot involved and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.The affected unit was returned for evaluation and no defect was found; therefore, a product non-conformance could not be confirmed.

Event Description

As reported, during use in patient with this swan-ganz catheter, it was difficult to insert and retract the catheter inside the introducer, especially between the 20 and 30 cm range.The introducer was size 8.5f for the swan ganz sized 7.5 f.After several attempts, it was completely impossible in the 30 cm zone, at a bulge located after the thermal filament zone.Finally, both the swan-ganz and introducer were needed to be removed at the same time.It was unable to be confirmed if a new stick was performed in order to introduce a new introducer.There was no allegation of patient injury.

• Brand Name: SWAN-GANZ CATHETERS
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 18719495
• MDR Text Key: 335525500
• Report Number: 2015691-2024-01087
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193466
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Lot Number: 65358714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1