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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); Low Blood Pressure/ Hypotension (1914); Vaso-Vagal Response (2661)
Event Date 07/18/2018
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 appeared to have a vasovagal response, and it was noted that the blood pressure declined. The freeze was aborted, and the patient's blood pressure continued to drop. The heart rate then slowed, then subsequently turned to ventricular fibrillation. Cardiopulmonary resuscitation and advanced cardiovascular life support (acls) protocol were then initiated, and the patient was defibrillated. It was noted that a brief episode of pulseless electrical activity (pea) was observed. A transthoracic echocardiogram was performed, and the case was aborted. The patient was under general anesthesia. The patient had an extended hospitalization, and the patient was reported to be stable. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Event summary: the patient data files showed at least two injections were performed with catheter 2af284/49774 on the date of the event without triggering of any system notice. The sheath was not returned for further investigation. Clinical issues (cardiac arrest, hypotension, vasovagal reaction and the case aborted under general anesthesia) were encountered during the procedure. There is no sufficient evidence that the device potentially caused these adverse events. In conclusion, clinical issues (cardiac arrest, hypotension, vasovagal reaction and the case aborted under general anesthesia) were encountered during the procedure. The sheath was not returned for further 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7779228
MDR Text Key116994734
Report Number3002648230-2018-00551
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 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number04482
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 Received08/15/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2018
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: 08/13/2018 Patient Sequence Number: 1
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