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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)
Event Date 10/23/2019
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed system notice #(b)(4) ¿there is a problem with the injection process¿ in application 1 with catheter 2af283 with lot number 19930. The files showed at least 1 application was performed with this catheter on the date of the event. The second patient file 3 hours later showed at least 4 applications were performed with balloon catheter 2af283 lot number 98653 without any issue on the date of the event. Clinical issues (cardiac tamponade, hypotension) occurred during the case. 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 during a cryo ablation procedure, the patient had cardiac tamponade, diagnosed by fluoroscopy and ultrasound echocardiogram, as well as low blood pressure. The blood was drained and the patient underwent protamine treatment. The case was aborted with the patient under general anesthesia. The patient was hospitalized. 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 Key9323834
MDR Text Key181986124
Report Number3002648230-2019-00778
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeIS
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,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/09/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number19955
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 Received11/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2019
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: 11/14/2019 Patient Sequence Number: 1
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