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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 Syncope (1610); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Pneumonia (2011); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Heart Failure (2206); Stenosis (2263); Respiratory Failure (2484); Low Cardiac Output (2501)
Event Date 05/09/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 990063-020: mapping catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a successful cryo ablation procedure, the patient had an acute onset of shortness of breath and a cough. The patient became hypoxic and went to the emergency room, where he was found to have bilateral pulmonary edema. A left heart catheterization was performed, and abnormal 80% stenosis extending into the left anterior descending artery was noted. A chest x-ray showed abnormal stable patchy airspace disease. A carotid arterial duplex showed abnormal 50% stenosis. Intravenous, oral and intramuscular medication was administered. The patient was hospitalized for a prolonged period. The patient's outcome is unresolved. No further patient complications have been reported as a result of this event.
 
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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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10085731
MDR Text Key193099696
Report Number3002648230-2020-00294
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
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,Followup,Followup
Report Date 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/05/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0009899354
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 Received07/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/06/2019
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: 05/25/2020 Patient Sequence Number: 1
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