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

Model Number 774F75

Device Problem Material Rupture (1546)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

One 774f75 catheter with an attached monoject 1.5 cc volume limited syringe and 1 three-way stopcock were returned for examination.Blood was visible on the catheter body.The reported event of balloon issue was confirmed.The balloon was found to be ruptured at the central area of the latex and the ruptured edges were not able to match up.However, the reported event of insertion issue was not able to be confirmed.The recommend introducer size for this catheter is 8.5 fr or 9 fr per the ifu.The catheter was able to pass through lab 8.5 fr and 9 fr introflex introducer without any restriction.A lab 0.021" guidewire (compatible size per (b)(6) ifu) passed through distal lumen without any problem.All through lumens were patent without any leakage or occlusion.As received, the distal heater bonding was torn, and blood was observed inside of the heater shrink wrapping and the torn edges appeared to match up.No other visible damage was observed on the catheter body and returned syringe.Visual examination was performed under microscope at 10x magnification and with unaided eye.A review of the manufacturing records indicated that the product met specifications upon release.As part of the manufacturing process, 100% balloon inflation and visual inspection is performed.A product risk assessment was initiated to address the failure.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 it was unable to advance the catheter to the pulmonary artery on the first day of use after the catheter was inserted from the left internal jugular vein.The customer deflated the balloon and removed the catheter, and the balloon was found damaged.During prep, the balloon inflated as expected.The catheter was replaced and the problem was solved.It is unknown if there was resistance felt against the introducer or guidewire.The manufacturer, the part number or the size of the introducer and the guidewire is unknown.Patient demographic information requested but unavailable.No patient complications were reported.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 12625245
• MDR Text Key: 276688760
• Report Number: 2015691-2021-05650
• 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,foreig
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63426151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2020
• 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