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

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.Lot number was not provided; therefore review of the manufacturing records could not be completed.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

The following information was obtained through an article published on cardiovascular intervention and therapeutics 2021: percutaneous removal of a knotted swan-ganz catheter.A (b)(6) year-old man who had undergone aortic valve surgery one week previously became hemodynamically unstable in the intensive care unit.His physician decided to insert a swan-ganz catheter (sgc) (edwards lifesciences, (b)(6) ) without fluoroscopic guidance.The sgc was inserted via the right internal jugular vein and advanced into the right ventricle, but it could not be advanced into the pulmonary artery.After repeated attempts, the physician pulled back the sgc, but it could not be retrieved.An x-ray examination showed a knot formation in the sgc.A new 5-fr sheath was placed in the right internal jugular vein, and a 0.014 inch guidewire (cruise; asahi intecc, tokyo, japan) was passed through the center of the knot.A 6-mm balloon (rx-genity, kaneka, tokyo, japan) was inflated to expand the knot diameter; however, the knot was not completely untied.A 10 mm-diameter amplatz goose neck snare (medtronic, dublin, ireland) was then advanced to the distal end of the sgc along with the cruise wire.The tip of the sgc was grasped and pulled back, causing the untying of the knot and a successful removal of the sgc.

• Brand Name: SWAN GANZ UNKNOWN
• 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 13077793
• MDR Text Key: 283508595
• Report Number: 2015691-2021-07011
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Male