MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-015

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

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after a cryo-ablation procedure, the patient experienced a cardiac tamponade.Additionally, the patient complained of sudden chest pain, dizziness, and it was noted the patient had hypotension.A bedside echocardiogram was performed and it showed a pericardial effusion.The patient was treated immediately with intravenous medications to improve the blood pressure.Additionally, a medication to reverse the effects of heparin was given as the activated clotting time (act) was not within range, and a reversed blood transfusion was also administered.A pericardiocentesis was also performed.The patient's blood pressure stabilized the following day.It was noted that intravenous fluids and albumin were administered again, and a pericardial drain was placed which evacuated a significant amount of serous fluid.The patient had an extended hospitalization, and has since been discharged from the hospital.No further patient complications have been reported as a result of this event.The patient was part of the (b)(6) study.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8140777
• MDR Text Key: 129571467
• Report Number: 9612164-2018-03501
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K102588
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2020
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 214782080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/07/2018
• Date Device Manufactured: 02/02/2018
• 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
• Treatment: 4FC12 SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 60