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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 Cardiac Arrest (1762); Death (1802); Great Vessel Perforation (2152); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 01/22/2019
Event Type  Death  
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, a pericardial effusion was observed. The balloon catheter was positioned twice, but occlusion was not obtained. Cardiac tamponade then occurred. The case was aborted, and the patient was under general anesthesia. An emergent surgery was then performed as the pericardial drainage was not enough to restore the patient's cardiac function. Surgery then revealed a "wound" in the left superior pulmonary vein (lspv), which is the size of the "balloon nose. " the patient experienced cardiac arrest, and subsequently died.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received confirmed that the left superior pulmonary vein (lspv) was perforated. Additionally, the cause of death was perforation.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received confirmed that the left superior pulmonary vein (lspv) was perforated. Additionally, the cause of death was perforation.
 
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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 Key8272328
MDR Text Key133909290
Report Number3002648230-2019-00044
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100010/S015
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 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number04226
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 Received01/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/30/2018
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: 01/23/2019 Patient Sequence Number: 1
Treatment
990063-020 MAPPING CATHETER
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