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

Model Number 131F7

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 05/16/2020

Event Type  malfunction  

Manufacturer Narrative

One 131f7 swan-ganz catheter with a 1.5cc syringe was returned for examination.The reported event of balloon issue was confirmed.The balloon did not inflate, it was found to be ruptured in approximately 0.1 mm long at the distal area of the balloon.The ruptured edges were not able to match up.No other visible damage was observed from the catheter body.All through lumens were patent without any leakage or occlusion.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this 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 were no patient complications reported.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 during catheter flushing and balloon inflation testing before implantation of this swan-ganz catheter, it was found that the front end of the balloon was damaged and could not be inflated.It was further indicated that bubbles were generated when the balloon end was placed in the water for inflation.Upon examination, a visible defect was found on the front of the balloon.The gas and a small amount of saline could be easily drawn during the retraction.There was no allegation of patient injury reported.The device was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10250939
• MDR Text Key: 199259833
• Report Number: 2015691-2020-12450
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 61697932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1