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

Model Number SWAN GANZ UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Rupture (2208); Respiratory Failure (2484)

Event Date 09/28/2015

Event Type  Death  

Manufacturer Narrative

The device was discarded at the hospital.No lot number was able to be obtained.Without the return of the product, it is not possible to determine if damages or defects existed on the product.It could not be determined if any clinical or procedural factors may have contributed to the event.No actions will be taken at this time.

Event Description

It was reported that customer experienced pulmonary artery rupture by a swan-ganz catheter.The patient expired.The patient was (b)(6) male.He was seeing a doctor regularly for double-chambered right ventricle and ventricular septal defect.The patient complained about palpitation and emergently visited a hospital.The patient was hospitalized.During hospitalization, bradycardia accompanied by sick sinus syndrome was exteriorized, the doctor decided to implant a pacemaker.The patient had complex cardiac anomaly, so before implanting the pacemaker, heart catheterization was performed.A swan-ganz catheter was inserted through an introducer inserted from the right internal jugular vein.With the balloon inflated, the catheter was advanced to pulmonary artery, then the patient suddenly coughed up massive amount of blood and respiratory failure occurred.The doctor intubated trachea to perform pulmonary artery coil embolization, but bleeding did not stop.The patient expired by respiratory failure and hemorrhagic shock.According to the results of autopsy, rupture and injury to the right pulmonary artery branch was observed and the patient was diagnosed with pulmonary artery rupture.Occurrence date is unknown.The device is not available from the hospital for evaluation.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9492504386
• MDR Report Key: 5166925
• MDR Text Key: 28900051
• Report Number: 2015691-2015-02816
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2015

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: 09/28/2015
• Initial Date FDA Received: 10/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR