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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 Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 06/03/2021
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The files confirmed system notice (b)(4) ¿the refrigerant delivery path is obstructed¿ in applications 3 and 6 through 9 with a non-returned balloon catheter. The files showed at least 9 applications were performed with this catheter on the date of the event. The files showed at least 3 more applications were performed with the same balloon catheter and system notice # (b)(4) was triggered at the beginning of the ablation phase of the applications 1 and 3. The files also showed at least 4 more applications were performed with a different non-returned balloon catheter with system notice # (b)(4) on all applications. In conclusion, the clinical issue (thrombosis) occurred during the procedure. There is no indication of relation of adverse event to the performance or malfunction of the product. The physical product has not been returned. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, a thrombosis formed in the sheath. The sheath was replaced to resolve the thrombosis. The case was completed with cryo. 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 Key12111937
MDR Text Key261049322
Report Number3002648230-2021-00336
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,Followup
Report Date 10/22/2021
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 Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010426747
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2020
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
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