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

Model Number 777F8

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 777f8 swan-ganz catheter with a non-ew contamination shield, 1.5cc monoject syringe and two stopcocks.The balloon was found ruptured.The ruptured edges did not appear to match up.All through lumens were patent without any leakage or occlusion.No other visible damage or abnormality was observed from the catheter body and returned syringe.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The customer report of a balloon issue 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 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 standard 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, but can lead to complications such as infection or small infarction.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.In this case there was no patient injury noted as the balloon leaked 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 prior to use of a swan-ganz catheter, a balloon leakage occurred while testing the device.There was no allegation of patient injury.Patient demographics were requested and not provided.The lot number was not known.

Manufacturer Narrative

A review of the manufacturing records indicated that the product met specifications upon release.Based on the engineering investigation performed, a root cause could not be determined, and a manufacturing or design non-conformance were not confirmed.The controls to detect the failure mode being evaluated are established in the manufacturing process.As part of the manufacturing process a 100% of the units go through a balloon visual and inflation inspection.

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: 9673886
• MDR Text Key: 191735111
• Report Number: 2015691-2020-10397
• 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,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 62294342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1