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

Model Number 777F8

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

One catheter with monoject limited volume syringe was returned for evaluation.Catheter balloon was found to be torn from the proximal and distal bonding sites and the central area of the balloon latex was missing.Bonding indication and residual latex were observed from the distal and proximal bonding sites.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency to the catheter body or returned syringe was observed.Visual examination was performed with 10 to 45x microscope.Customer report of inflation issue was confirmed during the analysis.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A review of the manufacturing records indicated that the product met specifications upon release.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.It is unknown if user or procedural factors may have 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 balloon did not inflate during use and we had to change out catheters in the middle of the procedure.No patient complications reported.(patient demographic information requested but unavailable).

Manufacturer Narrative

Add udi number (b)(4).

Manufacturer Narrative

Patient demographics were received and added.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10457717
• MDR Text Key: 205097824
• Report Number: 2015691-2020-13307
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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: 05/01/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63120784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 08/31/2020; 09/19/2020
• Supplement Dates FDA Received: 09/08/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 75