MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER; CATHETER, FLOW DIRECTED

Model Number 831F75

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported by the edwards sales representative that the customer requested that she come to the heart and vascular icu on (b)(6) 2019 to discuss issues they have been having with the model 831f75 swan-ganz catheter.During that visit, they told the rep that they had 2 separate incidents with faulty swan-ganz catheters occurring on their unit.It was reported in this event that the nurses didn¿t "trust the numbers they were getting" from a model 831f75 swan-ganz catheter because the numbers were "so off and don¿t make sense" when they performed a bolus.The nurse tried changing out the philips brand module that is used when hooked up to the edwards brand swan-ganz catheters.She also tried changing the co-set tubing and using an ice bath method of shooting the cardiac output, but the same results occurred.The patient was not injured.The lot number was not known.Per additional follow-up with the edwards representative, patient demographics were requested and the patient was male; however, no other patient information is able to be provided.

Manufacturer Narrative

Our product evaluation laboratory received one model 831f75 with a monoject limited volume syringe, double dpt kit, non-edwards introducer and contamination shield.The introducer and contamination shield were attached to the catheter body at approximately 50cm and 95cm from the distal tip.The distal lumen was occluded with blood.The catheter body had a kink located 95cm from the distal tip and appeared pinched at 49.5cm from the distal tip.Both the proximal injectate and infusion lumen was patent without any leakage or occlusion.The damaged locations on the catheter body were aligned to the locations of the proximal contamination shield connector and the introducer valve housing, respectively.The distal lumen was occluded with blood.No fault messages showed up on the lab vigilance ii monitor when the catheter was connected.The thermistor read 37.0°c when submerged into a 37.0°c water bath.The thermistor temperature reading was within specified accuracy, per the vigilance ii manual.The thermistor circuits were continuous with no open or intermittent conditions.The thermistor and proximal injectate port positions were measured at 1.47inches and 11.75inches from the distal tip, respectively.The positions were within specification.The balloon inflated clear and concentric and remained inflated for more than 5 timed minutes without leakage.The customer report of a cardiac output measurement issue was not confirmed during the 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 are well described in the literature.With any hemodynamic monitoring, values can change quickly and dramatically.Pressure tubing that is used with swan ganz catheters can also be a contributing factor to inaccurate values.In regard to the pressure tubing used with swan ganz catheters, it should be noted that poor dynamic response can be caused by air bubbles, clotting, excessive lengths of tubing, excessively compliant pressure tubing, small bore tubing, loose connections, or leaks.Pressure readings should correlate with the patient¿s clinical manifestations.It is unknown whether user or procedural factors contributed to the stated event.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) 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: 8960052
• MDR Text Key: 197086558
• Report Number: 2015691-2019-03291
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 831F75
• Device Catalogue Number: 831F75P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1