MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number 744F75

Device Problem Material Separation (1562)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after inserting the swan ganz catheter in a (b)(6) -year-old female patient to monitor a liver transplant, the user felt the balloon was hard to inflate and deflate as the syringe did not return spontaneously.In addition, they were not able to obtain a stable pulmonary artery curve.It was decided to remove the swan ganz catheter but during the withdrawal process the balloon detached, remaining inside the patient.The computed tomography (tdm) did not find the balloon at the pulmonary level.The swan ganz balloon had been tested before use in the patient without problems.The balloon was not retrieved to avoid long-term complications.There was no allegation of blood vessels injury or percutaneous intervention as it was stated that "the patient is doing well.".

Manufacturer Narrative

One 744f75 catheter with a 1.5cc syringe were returned for examination.The reported event of balloon inflation difficulty was confirmed.As received, the balloon was found torn next to proximal bonding area.The tear was measured to be 0.06" in length.The torn edges appeared to match up.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from the catheter body or returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Invasive procedures involve some patient risks.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this event, the product evaluation found no missing fragments from the balloon and there was no patient injury noted.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.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11930296
• MDR Text Key: 254343218
• Report Number: 2015691-2021-03280
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K924452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Device Lot Number: 63521001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65