MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ VIP+; CATHETER, FLOW DIRECTED

Model Number 834F75

Device Problems Malposition of Device (2616); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/05/2022

Event Type  malfunction  

Event Description

After reviewing the patient's evening chest x-ray, we noted that the pa line was malpositioned and coiled on itself, and the icu nursing staff noted difficulty with med administration through the line.At approximately 1230 this morning, we attempted to withdraw and reposition the pa line, being conscientious that the pa line was crossing the patient's recent operative site and homograft.We withdrew air from the pa balloon until no further air was able to be withdrawn, and no blood was noted in the pa line at this time.The pa catheter was successfully withdrawn approximately 7cm with little resistance into the right ventricle, positioning confirmed by waveform.At this time, the patient developed ectopy and the pa was repositioned slightly with resolution of ectopy.There was a minimal amount of blood at the balloon port at this time.The balloon was attempted to be re-inflated to refloat the pa line, but only approximately 1 cc of air was instilled into the balloon before encountering slight resistance.The balloon was not inflated further beyond level of encountering resistance.Upon deflating the balloon, blood was noted to be withdrawn from the balloon port.The decision was therefore made to withdraw the pa line, and upon retrieval of the pa line it was noted that the entire distal balloon of the pa catheter had been sheared off.The patient remained hemodynamically stable at this time without increase in his chest tube output.The pa line was kept for further evaluation by the team and ultimately the manufacturer.

• Brand Name: SWAN-GANZ VIP+
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 14546906
• MDR Text Key: 292969879
• Report Number: 14546906
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White