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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); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 11/12/2019
Event Type  Death  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The files showed at least ten applications were performed with a non-returned balloon catheter afapro28 with lot number 98536 on the date of the event. System notice # (b)(4). ¿the refrigerant delivery path was obstructed¿ was triggered at the beginning of the ablation phase in application #1 and #2. Subsequent applications were performed without any recorded anomalies. Clinical issues were encountered post procedure. In conclusion, the sheath was not returned for investigation. There is no indication of relation of adverse event to the performance of the cryo device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that following a cryo ablation procedure that was completed with cryo, low blood pressure was noted. The physician concluded the patient had a pericardial effusion resulting from cardiac tamponade. The reason for and time of the tamponade is unknown. A pericardiocentesis was performed, successfully increasing the blood pressure, but it did not stop the bleeding. The patient was transferred to cardiac surgery to stop the bleeding and close the tamponade; the bleeding was stopped successfully but the patient became hemodynamically unstable. The patient was transferred to the intensive care unit for monitoring and hemodialysis was performed. The patient passed away during the night.
 
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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 Key9403145
MDR Text Key168855534
Report Number3002648230-2019-00819
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/09/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number12965
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 Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2019
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: 12/03/2019 Patient Sequence Number: 1
Treatment
2ACH20 MAPPING CATHETER, AFAPRO28 BALLOON CATHETER
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