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

Model Number 774F75

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe was returned for evaluation.A non-edwards contamination shield was located on the catheter body between 62.5 cm and 89 cm proximal from the catheter tip.Balloon inflated, but resistance was felt when air was injected into balloon lumen.The balloon remained inflated for more than 5 minutes without leakage.It took 10.5 seconds for balloon deflation without the syringe attached and it was out of specification.The specification for balloon deflation without a syringe attached is 4 seconds.A stylet wire was passed from the gate valve to around the catheter tip.The cut down found that an unknown material (less than 0.5 mm x 0.5mm) were observed near the inflation port.No visible damage or deterioration was found from balloon.All through lumens were patent without any leakage or occlusion.No other visible damage to the catheter body was found.The material was sent to chemistry for testing.Balloon inflation test was performed using returned syringe with 1.5 cc air.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 balloon issue was confirmed.A supplemental report will be sent with the chemistry investigation results.In this evaluation, it is reported that the balloon deflation time was out of specification.During patient use, balloon deflation difficulty may result in an occlusion of blood flow and can result in distal ischemia.It can result in the physician intentionally over-inflating the balloon to burst.In this event, there was no patient compromise as an inflation difficulty was noted with the balloon before use.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 balloon on the swan ganz did not inflate at the inflation test before use.The catheter was exchanged and the problem was solved.Patient demographic information requested but unavailable.There were no patient complications reported.

Manufacturer Narrative

The unknown material was sent to chemistry for testing.The ir spectrum of the unknown material in the balloon inflation lumen showed similar absorption characteristics when comparing to poly (bisphenol a-co-epichlorohydrin) like material.An investigation was initiated and the material could be related to epoxy.The epoxy is used in the cco catheter manufacturing process during the assembly of the optical connector and in the yarn-kevlar assembly in the catheter tip.The inappropriate handling of the unit during this process could be associated to the occlusion in the inflation port.A personnel acknowledgment was provided to the manufacturing personnel as part of the complaint evaluation.Complaints incidence will continue to be monitored, and applicable actions will be taken as required.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• 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
• MDR Report Key: 8546673
• MDR Text Key: 143059093
• Report Number: 2015691-2019-01459
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61708870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1