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

Model Number 782F75M

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that when the nurse attempted to push iv fluid through the swan-ganz catheter for thermodilution measurement of cardiac output (co), the central venous pressure (cvp) tubing popped off and an unspecified amount of blood began to leak out.The cvp tubing came apart at the proximal hub on the swan-ganz catheter, which is a manufactured connection and not a luer connection.There was no allegation of patient injury.The customer was unresponsive to attempts at obtaining patient demographics and additional details such as the amount of blood loss, how the issue was resolved, and a lot number.

Manufacturer Narrative

Our product evaluation laboratory received one model 782f75m catheter with a monoject limited volume syringe.The proximal injectate extension was detached from the backform.The distal end of the proximal injectate extension tube was flush with the distal end of the insert.Per specification, the extension should be inserted at 0.250inches beyond the insert (+.150inches/-.150inches).The balloon inflated clear and concentric, and remained inflated for 5 timed minutes without leakage.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body.The customer report of "tubing came apart" was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures inherently involve some patient risks.Although serious complications associated with pulmonary artery catheters are relatively uncommon, the physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are well documented in the literature.It is standard clinical practice to inspect these devices prior to use on a patient during set-up and flushing.In the event that this issue is not noted before use, the catheter can be exchanged easily for another one, causing a minor delay in treatment or monitoring.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8251199
• MDR Text Key: 133851612
• Report Number: 2015691-2019-00190
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2018

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 Model Number: 782F75M
• Device Catalogue Number: 782F75M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2019
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 02/08/2019; 07/23/2020
• Supplement Dates FDA Received: 02/11/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1