• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
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) clinical study.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8140781
MDR Text Key129568168
Report Number3002648230-2018-00922
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/19/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number34179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1
Treatment
990063-015 MAPPING CATHETER
-
-