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

Model Number 774F75

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

Patient Problem No Code Available (3191)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and 2 three-way stopcocks was returned for evaluation.As received the catheter body was cut at 29.5 cm proximal from the catheter tip and blood was observed from the cut section.All lumens were exposed at the cut section.Leadwires and optical fibers were broken off at the cut section.Cross surfaces of the catheter body appeared smooth.Two longitudinal punctures, approximately 3 mm each, were also observed at the distal side of the cut section.The distal lumen, proximal injectate lumen and balloon inflation lumen leaked only from the cut section.After opening the optical module connector, blood was observed inside the connector.No visible damage or inconsistency to the catheter tip, balloon or returned syringe was observed.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of leakage issue and ¿the catheter was cut¿ was confirmed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.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.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

It was reported that there was blood leakage between the optical module connector and the extension tube during use.Upon attempting to remove the catheter from the patient it was found to be sewn into the patient.The patient¿s chest had to be reopened to remove the catheter.The physician commented that the catheter had to be cut to be removed from the patient¿s chest.The physician believed that the catheter tip was damaged during the initial surgical procedure causing blood leakage at the optical module connector.No patient complications were reported.Inquired of patient demographics but unable to be obtained.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was able to be obtained.The surgery performed in this event was a mitral valve replacement to correct mitral valve regurgitation and infective endocarditis.Patient demographics were able to be obtained.See section a for details.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CATHETER
• 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: 6547419
• MDR Text Key: 74583435
• Report Number: 2015691-2017-01225
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

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: 774F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 59