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

Model Number 131F7P

Device Problems Difficult or Delayed Positioning (1157); Material Separation (1562)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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 a part of the monthly review.

Event Description

It was reported via medwatch (b)(4) that a knot on a 7f swan ganz catheter was seen while inside the right femoral vein during a right heart catheter and stenting procedure.In an attempt to untie the knot, the catheter broke into two pieces.Vascular surgeon was needed to surgical remove the device.The 7f swan ganz was inserted via a 7f sheath in the right femoral vein.Although there was difficulty obtaining the right femoral venous access, a 7f sheath was able to be successfully inserted.Staff experienced difficulty again, but with the advancing of the swan ganz catheter.A 0.25 wire was inserted to help advance the swan.To help troubleshoot, an xray was used.The xray panned down to the right groin area and a knot in the swan was seen.Staff attempted to untie the knot by removing the sheath and swan.As the sheath was removed, the catheter broke into two pieces.A portion of the swan was sticking out of the skin of the patient.The knot was still in the right femoral vein.Another attempt was made to remove the knot.A new access site was obtained in the left formal vein and a snare was inserted via a 10f sheath.The snare was able to grab the knot, but the knot was unable to move across to the left groin.This was too painful for the patient.A 7f sheath was inserted in the right femoral vein over the piece of swan that was sticking out of the skin.A vascular surgeon was called.He exchanged the 7f sheath in the right femoral vein for a 16f sheath.The snare was re inserted in the 16f sheath in the right femoral vein, but the knot could not be removed.The cardiovascular operating room team entered the procedure.A second vascular surgeon was needed to relieve the first surgeon.Second surgeon performed a vascular cut down on the right femoral vein and the knot was retrieved.Procedure was done under local anesthetic to the right groin.Patient was discharged the next day without known harm.Patient is an 91 year old male with a past history of coronary heart disease.

Manufacturer Narrative

A product evaluation was completed.The reported event of knot and broke into two pieces were confirmed.Multiple knots was observed at about 10cm of the catheter body.Crimped marks were observed at about 15cm, 26cm and 28cm of the catheter body.Catheter body with thermistor leadwires were broken into two halves at 30cm of the catheter body.The surface of the break appeared rough and uneven.The edges at the break appeared to match up.Catheter body was looped and the thermistor leadwires were bunched from 48cm to 95cm.No other visible abnormality was observed from the balloon or catheter.Engineering evaluation was also completed.Corrections to the h6 codes type of investigations, investigation findings, and investigation conclusions were made.A device history record review was completed and documented that device met all specifications upon distribution.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 a part of the monthly review.

• Brand Name: SWAN GANZ THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17572664
• MDR Text Key: 321628077
• Report Number: 2015691-2023-15316
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103000405
• UDI-Public: (01)00690103000405(17)250509(11)230510(10)65067168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 131F7P
• Device Lot Number: 65067168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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): Required Intervention; Other
• Patient Age: 91 YR
• Patient Sex: Male