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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 Problem Vascular Dissection (3160)
Event Date 03/22/2019
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least 7 applications were performed with balloon catheter 2af284 with lot number 21662, without any issue on the date of the event. A clinical issue was encountered during the procedure. The sheath was not returned for product analysis and thus, could not be investigated. 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 tip of the sheath was then advanced deeper in the pv than usual, after which the mapping catheter was inserted. When angiography was performed, the contrast agent did not flow, and the contrast agent was dense and stagnated at the pv bifurcation. There was a dissection of the pv and the tip of the sheath was implicated. Ultrasound was performed, and no pericardial effusion was noted. The case was completed with cryo. The patient recovered. 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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8532044
MDR Text Key142507848
Report Number3002648230-2019-00288
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
Report Date 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/02/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number59056
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 Received03/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2018
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: 04/19/2019 Patient Sequence Number: 1
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