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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 Death (1802); Great Vessel Perforation (2152); Blood Loss (2597); Pericardial Effusion (3271)
Event Date 06/21/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was deceased. The physician attempted a couple of freezes in the left superior pulmonary vein (lspv) with no good occlusion. Then, they proceeded to the right inferior pulmonary vein (ripv) and later returned to the lspv. However, there was no time to isolation (tti). Then, another freeze was attempted but there was a sudden pressure drop. An effusion was noted and a pericardiocentesis was done. Additionally, there was a perforation in the lspv. Furthermore, there was a lot of blood which could not be contained. The patient bled out due to a hole or tear in the lspv and passed away. The cause of the perforation was unknown.
 
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least 16 applications were performed with balloon catheter 2af284 with lot 66715 without any issue on the date of the event. Data files not able to confirm the clinical issues. The physical product was not returned for investigation. 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 Key8843875
MDR Text Key152744747
Report Number3002648230-2019-00552
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
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 Received08/05/2019
Was Device Evaluated by Manufacturer? Yes
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: 07/30/2019 Patient Sequence Number: 1
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