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

Model Number 744F75

Device Problems Material Rupture (1546); Defective Component (2292)

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

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 744f75 swan-ganz catheter.As received, the catheter passed in-vitro calibration and attenuation test with the lab cal-cup; however, the balloon was found to be torn at the interior edges of both the proximal and distal bonds extending around the catheter.The missing piece of latex was not returned.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body or the returned syringe.A device history record review was completed and documented that the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint; however, the customer report of a svo2 issue was not confirmed on evaluation, as the device responded appropriately during functional testing.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.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 a swan-ganz catheter could not measure svo2 (mixed venous oxygen saturation).There was no allegation of patient injury.Patient demographics were requested but not received.

Manufacturer Narrative

As a latex balloon piece was discovered missing from the returned unit on evaluation, additional follow-up with the customer was performed.No additional intervention was needed to solve the issue and there was no patient injury.Patient demographics are not available.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8181569
• MDR Text Key: 131332460
• Report Number: 2015691-2018-05442
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K924452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Model Number: 744F75
• Device Catalogue Number: 744F75
• Device Lot Number: 61385143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1