MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN GANZ CATHETER

Model Number SWAN GANZ UNKNOWN

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Perforation of Vessels (2135)

Event Date 07/04/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.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.Vascular complications, specifically pulmonary artery perforations, are listed as a potential complication in the product instructions for use (ifu).In this case, the reporter believed the cause of perforation was when the heart was manipulated while the patient was on bypass.There is no allegation of product malfunction.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

Information was obtained from the journal article ¿emergency treatment with veno-arterial ecmo for a case with iatrogenic intra-tracheal bleeding caused by pulmonary injury by swan-ganz catheter¿ jpn j extra-corporeal technology 45 (4) : 389- 392, 2018.It was reported that massive bleeding from the intubation tube was confirmed with hemodynamic collapse after removal of a swan ganz catheter during aortic valve replacement and coronary artery bypass surgery.Reportedly, the catheter had been placed deeply, about 5 cm, before surgery.A decrease of blood pressure and massive bleeding were confirmed when the anesthesiologist removed the catheter, during hemostasis, after surgery.Cardiopulmonary bypass (cpb) through the right axillary artery was resumed and veno-arterial extracorporeal membrane oxygenation (va-ecmo) was introduced.The patient was transferred to the icu.Ecmo was controlled to a flow rate of 2.0 l/min/m2 without anticoagulant therapy.On postoperative day (pod) 2, the bleeding became able to be controlled and anticoagulant therapy was initiated as well.On pod 4, hemostasis was obtained with coil embolization under v-a ecmo.On pod 5, hemodynamics became stable and v-a ecmo was weaned off.On pod 21, the patient left the icu.It states that it is considered the catheter perforated the pulmonary artery and the lung when the heart, which was collapsed by cpb was turned over during coronary artery bypass surgery, resulting in massive bleeding and hemodynamic collapse.The patient is a (b)(6)-year-old female with a medical history of aortic valve stenosis and chronic renal failure with dialysis, myelodysplastic syndrome and arteriosclerosis obliterans.Occurrence date is unknown.The device was not available for evaluation.

Manufacturer Narrative

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

• Brand Name: SWAN GANZ CATHETER
• Type of Device: SWAN GANZ CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8828889
• MDR Text Key: 152359381
• Report Number: 2015691-2019-02766
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• 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: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 46