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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 Bacterial Infection (1735); Dyspnea (1816); Pleural Effusion (2010); Cardiac Tamponade (2226)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, hemodynamic destabilization and pulsus paradoxus occurred. Cardiac tamponade was confirmed via echocardiography and drainage was subsequently performed. The patient became hemodynamically stable. The case was completed with cryo. The patient had an extended hospitalization. It was noted that another hospitalization occurred post procedure, as the patient had dyspnea. The patient has 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) study.
 
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
Incoming information indicated that patient also had a cough. Bilateral pleural effusions were found via echocardiography. A pleural puncture was subsequently performed, and pleural fluid analysis confirmed presence of bacteria. Intravenous and oral medications were administered.
 
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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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7332590
MDR Text Key102180199
Report Number3002648230-2018-00162
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeBE
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,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/20/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number37385
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 Received03/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2017
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: 03/12/2018 Patient Sequence Number: 1
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