MAUDE Adverse Event Report: ST JUDE MEDICAL SYSTEMS AB PRESSUREWIRE; GUIDEWIRE SENSOR

Model Number C12058

Device Problem Insufficient Information (3190)

Patient Problems Angina (1710); Embolism (1829)

Event Date 12/19/2013

Event Type  Injury  

Event Description

During an exchange from pressure wire aeris to an oct-catheter the patient experienced angina pectoris caused by an air embolism.The patient received morphine to treat the angina pectoris and after a few seconds, the symptoms dissolved.

Manufacturer Narrative

The product was not returned.A review of the device history record confirmed that the device was manufactured according to sjm specification.We do not believe the cause of the angina pectoris was due to a device malfunction or any deficiency with the instructions for use requiring corrective action.We will continue to closely monitor the performance of this product for any significant trends.

• Brand Name: PRESSUREWIRE
• Type of Device: GUIDEWIRE SENSOR
• Manufacturer (Section D): ST JUDE MEDICAL SYSTEMS AB; palmbladsgatan 10; box 6350; uppsala SE-75 1 35; SW SE-751 35
• Manufacturer Contact: emil anderas ; palmbladsgatan 10; box 6350; uppsala SE-75-1 35 ; SW SE-751 35 ; 8161000
• MDR Report Key: 3659363
• MDR Text Key: 19973153
• Report Number: 8030904-2014-00004
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C12058
• Device Lot Number: 135399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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): Required Intervention