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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 Problems Air Leak (1008); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Dyspnea (1816); Inflammation (1932); No Code Available (3191); Pericardial Effusion (3271)
Event Date 02/28/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that six days after a cryo ablation procedure, the patient experienced chest pain and shortness of breath. Pericarditis was diagnosed, and heart palpitations were also observed. An echocardiogram was performed, and mild pericardial effusion was confirmed. Medication was administered. The case was completed with cryo. No further patient complications have been reported as a result of this event. This patient was part of the stop af first study. Incoming information indicated that a pulmonary embolism was observed and the hospitalization stay was extended.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received indicated that during the patient's follow up visit, the patient's cough worsened, and the patient presented with chest pain, persistent shortness of breath. The patient's medications were adjusted accordingly.
 
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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 Key7365915
MDR Text Key103321266
Report Number3002648230-2018-00179
Device Sequence Number1
Product Code DRA
UDI-Device Identifier00643169688872
UDI-Public00643169688872
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number64425
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 Received04/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/14/2017
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: 03/23/2018 Patient Sequence Number: 1
Treatment
BALLOON CATHETER 2AF284
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