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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 Arrhythmia (1721); Cardiac Arrest (1762); Loss of consciousness (2418)
Event Date 02/09/2021
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 palpitations and discomfort. The electrocardiogram (ecg) indicated an atrial flutter episode. The patient lost consciousness and experienced cardiac arrest for eight seconds. The ecg then showed normal sinus rhythm. The following day, the patient had the same symptoms of palpitations with the ecg showing tachycardia episodes. The patient lost consciousness and experienced cardiac arrest once again. Medication was administered and the patients hospitalization stay was extended. A temporary pacemaker was used and then five days later a permanent pacemaker was implanted. The case was completed with cryo. The patient is a participant in a clinical study. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12108596
MDR Text Key259660968
Report Number3002648230-2021-00334
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeCH
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 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/16/2022
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010080671
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 Received06/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/17/2020
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: 07/02/2021 Patient Sequence Number: 1
Treatment
990063-020 MAPPING CATHETER
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