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

Model Number 131F7P

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Needle Stick/Puncture (2462); Unspecified Vascular Problem (4441)

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

One swan ganz catheter was received by our product evaluation laboratory for a full examination.The report of placement difficulties was unable to be confirmed during evaluation.As received, catheter was found completely cut at approximately 4cm from backform.Cut appeared straight and even and matched.Balloon inflation could not be performed due to cut catheter.No visible damage noticed from balloon.No other visible damage from catheter body.The lot number for this device was not supplied; therefore, further review of the related manufacturing records could not be performed.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.

Event Description

As reported, during insertion for a right ventricular assessment function, this swan ganz catheter got stuck in the right sideway of iliac vein.User tried to pull the catheter back, deflate the balloon with a bigger syringe and remove the syringe and open the gate valve but the product remained stuck.Radiologist and surgeon were called to see if there was vessel perforation, but since the image was inconclusive, it was decided to cut the swan ganz catheter and keep inserted the part of the device that was inside the patient.In the meantime, a new swan ganz was placed through the left femoral vein to finish the monitoring.After that, around an hour and a half later, patient went into surgery to remove the catheter through the abdomen.Before its use, the catheter had been tested and the balloon inflated and deflated.There was no perforation of the vessel.Patient is doing well.The device is available for evaluation.

Manufacturer Narrative

Further investigation was completed by the engineers in the manufacturing site.It could be determined that as part of the manufacturing process, the units go through a balloon inflation inspection and a leak and flow test.Based on the available information it could not be confirmed that this complaint is associated to a manufacturing or design defect.

• 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: 17630351
• MDR Text Key: 322025740
• Report Number: 2015691-2023-15513
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131F7P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 70 KG