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

Model Number 777F8

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and a three-way stopcock was returned for evaluation without the packaging.The 8fr terumo radifocus introducer was not returned.Resistance was observed when the catheter was inserted into a lab 8 fr introflex introducer which is not the recommended size introducer per the ifu.No resistance was observed when the catheter was inserted into a lab 9 fr introflex introducer which is the recommended size introducer per the ifu.The balloon was found to be torn along the distal and proximal side of the balloon bonding areas.The latex between the bonds was not returned.Latex was still attached over the bond sites.All through lumens were patent without any leakage or occlusion.No other visible damage or inconsistency to the catheter body, balloon, or returned syringe was observed.Further examination found the catheter od to be within specification at 0.110" which is the maximum specification for the thermal filament.Visual examination was performed under microscope at 20x magnification and with unaided eye.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Customer report of ¿the catheter did not pass through the introducer¿ could not be confirmed during the evaluation; however, the balloon was found to be torn and was not returned.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.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.It should be noted that the clinician did not use the ifu recommended introducer size of 9fr which may contributed to the event.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 the catheter did not pass through the introducer from the femoral approach on the first day of use.The catheter was replaced and the problem was solved.There were no patient complications reported.The introducer used was an 8fr terumo radifocus and the guidewire was 0.025 inch.It was further confirmed that the patient was transferred to a different hospital.Post procedural patient status could not be confirmed.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP 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: 6396054
• MDR Text Key: 69641118
• Report Number: 2015691-2017-00618
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777F8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Date Manufacturer Received: 02/14/2017
• 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