MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS

Model Number C315S1002

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

Patient Problems Syncope (1610); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 07/19/2018

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 the implant procedure, the patient experienced perforation and tamponade at the right ventricular anterior wall and the apex.The patient¿s blood pressure decreased and subsequently lost consciousness and did not respond to the nurse¿s voice.Drainage was performed immediately, and as a result, the pulse rate was improved.The surgeon suspected that the perforation at the right ventricular anterior wall was caused by the catheter, and the other site at the apex was possibly pierced by mistake during drainage.The patient received thoracotomy and was in stable condition.It was noted that myocardial fibrosis was observed while suturing the perforation sites, and the fibrosis was so severe that the myocardium could collapse by a suture needle, which indicated that the patient had a very high risk of perforation.No further patient complications have been reported as a result of this event.

• Brand Name: DEFLECT
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7782514
• MDR Text Key: 117129826
• Report Number: 9612164-2018-02044
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C315S1002
• Device Catalogue Number: C315S1002
• Device Lot Number: 0009157812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR