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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); Perforation (2001); Cardiac Tamponade (2226)
Event Date 11/23/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 990063-020 mapping catheter. Product event summary: the data files were returned for analysis. The files showed that at least 17 applications were performed with a returned balloon catheter without any issue on the date of the event. In conclusion, the clinical issues, perforation, tamponade and cardiac arrest, occurred during the procedure. There is no indication of relation of the adverse event to the performance or a malfunction of the product. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryoablation procedure, the patient experienced cardiac tamponade after the heart was perforated. A pericardial puncture was performed to drain the fluid surrounding the heart. The patient then went into cardiac arrest. Cardiopulmonary resuscitation (cpr) was performed and the patient stabilized. The case was aborted. 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 Key13044140
MDR Text Key282504017
Report Number3002648230-2021-00580
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010860898
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2021
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: 12/20/2021 Patient Sequence Number: 1
Treatment
AFAPRO28 BALLOON CATHETER
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