MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT; CATHETER, FLOW DIRECTED

Model Number TS105F5

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

One ts105f5 catheter with attached non-edwards stopcocks were returned for examination.The reported event of "balloon would not inflate" was confirmed.The balloon was found torn around circumferences at both the proximal and distal bonds.Balloon latex between the tears was missing from the catheter and was not returned.The edges of the balloon tears appeared rough and uneven.Dry blood was visible at the balloon bond areas and inflation port.All through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body.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.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 prep for a rt.Hearth catherization on a (b)(6) male patient, the balloon would not inflate.A second catheter was opened and worked, but when the physician went to removed it, the balloon was gone.It was concluded that it is in the patient's body.There was no resolution and no retrieval attempted.There were no complications reported.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER 24 CM PROXIMAL PORT
• 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: 10045469
• MDR Text Key: 195000663
• Report Number: 2015691-2020-11832
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• Device Model Number: TS105F5
• Device Catalogue Number: TS105F5
• Device Lot Number: 62604224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1