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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 Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Event Date 01/20/2022
Event Type  Injury  
Event Description
It was reported that during a cryoablation procedure, approximately 10 minutes after the transseptal puncture was performed the patient experienced a significant drop in blood pressure. A pericardial effusion was detected with an intracardiac echocardiogram. A pericardiocentesis was successfully performed and the patient required extended hospitalization. The case was aborted. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key13343393
MDR Text Key284369642
Report Number3002648230-2022-00030
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIT
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 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010892897
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/20/2021
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: 01/25/2022 Patient Sequence Number: 1
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