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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 Fluid Leak (1250); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2019
Event Type  malfunction  
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 balloon catheter was inserted into the sheath and a small air was continuously introduced intermittently while flushing the sheath. After the balloon catheter was removed from the sheath, a competitor product was inserted and air continued to be observed. The case was completed with cryo. No 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 Key9306852
MDR Text Key195262522
Report Number3002648230-2019-00759
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeJA
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 12/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number12882
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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