MAUDE Adverse Event Report: ST. JUDE MEDICAL GUIDERIGHT GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number 404570

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Internal Organ Perforation (1987); Cardiac Tamponade (2226)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.The guideright guidewire instructions for use states that insertion into artery may cause excessive bleeding and/or other complications.The guideright guidewire instructions for use states that complications may occur during certain procedures but may not be limited to air embolism, hematoma formation, sepsis/infection, excessive bleeding, vessel damage.

Event Description

A guideright guidewire was used to locate the coronary sinus.During the procedure, it appeared as though the wire had reached the sinus.A balloon was delivered and inflated, and contrast was injected.Following inflation, it was determined the wire had reached the pericardium and not the sinus.Tamponade occurred.A surgeon performed a percutaneous drain, which was unsuccessful in resolving the tamponade.A thoracotomy was then performed; the blood was successfully drained.Despite attempts by the surgeon, the perforation still could not be located.The opinion of the cardiac surgeon was that the perforation had resolved without intervention due to the small size of the perforation.The patient later expired.No information was made available as to the date of death, reason for the patient's death, nor any further medical intervention.

• Brand Name: GUIDERIGHT GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5762502
• MDR Text Key: 48575915
• Report Number: 2182269-2016-00012
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K935170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: 404570
• Device Catalogue Number: 404570
• Device Lot Number: 9912509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention