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U.S. Department of Health and Human Services

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

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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 Low Blood Pressure/ Hypotension (1914); Pain (1994); Dizziness (2194); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 10/11/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that immediately after a cryo ablation procedure, a pericardial effusion that progressed to a cardiac tamponade was detected by an echocardiogram. Hypotension was experienced by the patient and a medication to improve the blood pressure was administered intravenously. A pericardiocentesis was performed and the patient stabilized. The case was completed with cryo. It was noted that the patient's hospital stay was extended. No further patient complications have been reported as a result of this event. The patient was part of the (b)(6) clinical study.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that the patient also experienced thoracic pain and dizziness. Additionally, heparin administration also contributed to the occurrence of the cardiac tamponade. The patient is currently stable.
 
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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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8084669
MDR Text Key127580341
Report Number3002648230-2018-00848
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGR
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,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/13/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number30050
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 Received01/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/14/2018
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: 11/19/2018 Patient Sequence Number: 1
Treatment
990063-020 MAPPING CATHETER
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