MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number 6227DEF04

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

Patient Problems Great Vessel Perforation (2152); Vascular Dissection (3160)

Event Date 02/09/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during left ventricular (lv) lead replacement, while trying to cannulate the coronary sinus with catheters, the coronary sinus was dissected and a perforation occurred.The patient was sent to cardiac surgery, intubated, the catheters were removed, and an epicardial lead was placed.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8503684
• MDR Text Key: 141591687
• Report Number: 9612164-2019-01289
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2019
• Device Model Number: 6227DEF04
• Device Catalogue Number: 6227DEF04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2019
• Date Device Manufactured: 11/08/2017
• 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
• Treatment: DTMA1QQ CRT-D, 5076-45 LEAD, 6935M55 LEAD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR