MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

Model Number 774HF75J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Aortic Insufficiency (1715)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product; however, the customer commented that the problem is not considered to be device related.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.

Event Description

It was reported that a swan ganz catheter was sewn to the patients's blood vessel when the patient was sutured after aortic valve replacement.The patient was noted to have aortic valvular stenosis and the complications of angina (after coronary artery bypass grafting and percutaneous coronary intervention), diabetes and hypothyroidism.After the surgery, blood leakage was observed from several lumens of the catheter.The clinician could not remove the catheter due to resistance and suspected the catheter to be sewn to the blood vessel, so the patient's chest was reopened.The catheter was found to be sewn to the brachiocephalic vein.The suture thread was cut and the catheter was removed.The patient recovered.The customer commented that the problem is not considered to be device related.There were no patient complications reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5942987
• MDR Text Key: 54438862
• Report Number: 2015691-2016-02712
• Device Sequence Number: 1
• Product Code: DQE
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 774HF75J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/12/2016
• 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
• Patient Age: 75
• Patient Weight: 44