MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, FLOW DIRECTED

Model Number 834F75

Device Problems Material Rupture (1546); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

One 834f75 with a non-edwards contamination shield and monoject limited volume syringe were returned for examination.The reported event was unknown.The catheter balloon was found to be ruptured.The central area of the balloon latex was missing.The thermistor was submerged in a 37.0c water bath and read 36.9c on the vigilance ii.All through lumens were patent without any leakage or occlusion.No visible damage or inconsistency was observed from the catheter body and returned syringe.Lot number was not provided, therefore review of the manufacturing records could not be completed.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.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

The medsun number received is mw5094547.However, the device returned for examination has a different model number than what was on the medsun report.Multiple attempts have been made with the customer to see if there was a typo or if there should be another complaint reported, with no response to date.A complaint was opened for the model number received (834f75) with an unknown complaint event.During the evaluation of this unknown event, it was determined to be reportable for missing latex.Patient demographics are unable to be obtained.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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: 10336221
• MDR Text Key: 201852195
• Report Number: 2015691-2020-12774
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K810352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 834F75
• Device Catalogue Number: 834F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1