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

Model Number 131F7

Device Problems Material Rupture (1546); Gas/Air Leak (2946)

Patient Problems Chest Pain (1776); Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 131f7 swan-ganz catheter, which was the second catheter reported to have failed.The balloon latex appeared to be ruptured in the central area of the balloon.The balloon edges did not match at the ruptured region.The inflation lumen and proximal injectate lumen were found to be occluded with clotted blood, which were not able to be removed with warm water and a stylet wire.The distal lumen was found to be patent and did not leak.No other visible damage or inconsistency was observed from the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.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.Additionally, the hilum of the lung is the wedge-shaped area on the central portion of each lung, located on the medial (middle) aspect of each lung.The major bronchi, pulmonary arteries, pulmonary veins, and nerves are the structures which enter and exit the lungs in this region.Lymph nodes, called hilar lymph nodes, are also present in this region.Both hilum are similar in size, with the left hilum usually found slightly higher in the chest than the right hilum.A small amount of air introduced into the pulmonary circulation would travel to the periphery of the lung and eventually be re-absorbed.As a result, it is not possible for 1-2mls of air to enlarge the large vascular structures in the hilum.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 was being used to check the pre-operative diagnosis of heart transplantation in a (b)(6) year-old male with heart failure (whose heart function was reportedly ¿one-fifth compared with normal people¿), when the balloon burst while in the pulmonary artery.The customer reported that the balloon burst led to 1ml of air entering the patient's pulmonary artery.Another swan-ganz catheter from a different lot number was used, but the same issue occurred with another 1ml of air entering the patient¿s pulmonary artery.The balloons on both swan-ganz catheters had passed pre-procedure testing and inspection.The tip of each catheter had reached the proper position in the pulmonary artery during placement and the balloon was then deflated without issue; however, each balloon burst when re-inflated to measure the pulmonary artery occlusion pressure (paop).It was also reported that during the operation, the patient ¿suffered from pain and then the operation was finished.¿ then from (b)(6) 2019, the patient reported right chest pain though all other vital signs were stable.The attending physician provided computed tomography (ct) reports from before and after the reported event.The physician mentioned that enlargement of the right hilum of the lung was related to air entering into the pulmonary artery in each instance.There was no allegation of patient injury.

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 00610
• MDR Report Key: 8628965
• MDR Text Key: 146345491
• Report Number: 2015691-2019-01811
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: 131F7
• Device Catalogue Number: 131F7P
• Device Lot Number: 61428236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR