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U.S. Department of Health and Human Services

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

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MEDTRONIC CRYOCATH LP FLEXCATH SELECT STEERABLE SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number 990065
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271); Heart Block (4444)
Event Date 08/31/2021
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 successful pulsed field ablation procedure, the patient became hypotensive and a pericardial effusion was diagnosed via intracardiac echocardiography (ice). Additional diagnostic tests were performed and st elevation with sinus tachycardia and a first degree heart block were noted on the electrocardiogram (ecg). A pericardiocentesis was performed to treat the effusion. Pain medication was administered due to the patient experiencing chest pain. The patient hospitalization stay was extended. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
 
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Brand NameFLEXCATH SELECT STEERABLE SHEATH
Type of DeviceINTRODUCER, CATHETER
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 Key12634937
MDR Text Key276472019
Report Number3002648230-2021-00468
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number990065
Device Catalogue Number990065
Device Lot Number0010691254
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 Received09/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2021
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: 10/14/2021 Patient Sequence Number: 1
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