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 Cardiac Perforation (2513); Complete Heart Block (2627)

Event Date 08/27/2015

Event Type  Death  

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.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.

Event Description

It was reported that an (b)(6) patient experienced right ventricular perforation by a swan-ganz pacing catheter that was placed for complete heart block.During placement of the swan-ganz pacing catheter the patient experienced chest discomfort and went into shock.Echocardiography was performed and significant pericardial effusions were noted.Ct scan was performed and it was noted that the swan ganz catheter had perforated the right ventricle.The patient underwent surgery for repair of the right ventricle.Post-surgery the patient had stable hemodynamics, however, the patient developed ventilator-associated pneumonia.The patient expired on post-op day 7 from pneumonia associated complications.

• 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: 5092202
• MDR Text Key: 26347746
• Report Number: 2015691-2015-02494
• 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
• Report Date: 08/27/2015

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: Not provided
• Initial Date FDA Received: 09/21/2015
• 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: 86 YR