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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 Non specific EKG/ECG Changes (1817); Vomiting (2144)
Event Date 02/17/2022
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, the patient experienced st elevation and a coronary angiogram (cag) was performed to check for air contamination. There was no issues detected and the sheath was  inserted into the left atrium and the right inferior pulmonary vein (ripv) ablations were preformed. When the sheath was relocated to perform the right superior pulmonary vein (rspv) ablation, the st elevation increased again and resolved immediately. Per the physician the patient was experiencing spasms. The procedure continued. The sheath was positioned in the right atrium and atrial fibrillation (af) would not stop.  direct-current (dc) cardioversion was performed twice. The case was completed with cryo. The patient complained of poor physical condition and vomited. Th patient's condition suddenly changed. The emergency physician was called to treat the patient and the patient's conditioned improved a little. The treatment details are unknown. The patient's hospitalization was extended. Per the physician, the blood vessel in the inguinal region was complicated and it was possible that it was injured during the puncture. The bin files could not be create d.  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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13715276
MDR Text Key287802680
Report Number3002648230-2022-00097
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010847546
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/09/2022 Patient Sequence Number: 1
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