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

Model Number 096F6P

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The product was not available for product evaluation since it was discarded by the hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.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 a right catheterization through the right basilic vein, this 6f swan ganz catheter did not advance and got stuck in the vein.The exam was stopped and the device withdrawn.Even vasodilators were administered, the device could not be removed and sedation was required to pull stronger; with stripping of the right basilic vein that needed compression bandage.Since this incident user is not doing humeral approach anymore.There was no allegation of patient injury.The device was not available for evaluation since it was discarded.

Manufacturer Narrative

Updated: h6 (impact code, investigation findings, investigation conclusions) h10 manufacturer narrative: although the device was not received for evaluation, an image was sent for investigation.As per image provided, a stripped vessel could be observed.The cause of stripped vessel could not be determined.Further investigation was performed by the engineers in the manufacturing site and a potential failure mode could be related to balloon inflation issues since balloon is used to place the catheter in position.However, as the product was not returned for evaluation, a product non-conformance or device failure mode could not be confirmed.In addition, the manufacturing records were reviewed and there is no indication of a related nonconformance; all process parameters were met, and inspections passed successfully.Furthermore, as part of the manufacturing process, all units go through a balloon inflation inspection.Edwards will continue to review and monitor all events.

• 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: 16572572
• MDR Text Key: 311579385
• Report Number: 2015691-2023-11595
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 096F6P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 58 KG