MAUDE Adverse Event Report: ST. JUDE MEDICAL - ATLANTA CARDIOMEMS HF SYSTEM; HEART FAILURE SENSOR

Catalog Number CM2000

Device Problem Malposition of Device (2616)

Patient Problems Chest Pain (1776); Hemoptysis (1887)

Event Date 06/15/2015

Event Type  Injury  

Event Description

It was reported that post implant the appropriate waveform could not be obtained during calibration of the sensor.Troubleshooting using multiple units was attempted to no avail.It was also reported that during a subsequent right heart catheter procedure, the sensor was found to be implanted i na vessel less than the specified size per the labeling instructions.The physician was unable to successfully relocate the sensor (this is not a labeled practice) after approximately an hour as the patient developed hemoptysis and chest pain.As a result, the procedure was abandoned.The patient received protamine and was stabilized.The patient has since recovered.

Manufacturer Narrative

On the initial mdr a digit was inadvertently omitted from the pma/510k#.The pma/510k# has been corrected accordingly.

• Brand Name: CARDIOMEMS HF SYSTEM
• Type of Device: HEART FAILURE SENSOR
• Manufacturer (Section D): ST. JUDE MEDICAL - ATLANTA; atlanta GA
• Manufacturer Contact: ty cowart ; 387 technology circle; atlanta, GA 30313 ; 6786512383
• MDR Report Key: 4911582
• MDR Text Key: 6025524
• Report Number: 3004936110-2015-00007
• Device Sequence Number: 1
• Product Code: MOM
• Combination Product (y/n): N
• PMA/PMN Number: P0100045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Type of Report: Initial,Followup
• Report Date: 06/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: CM2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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): Other
• Patient Age: 51 YR