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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 Edema (1820); Pseudoaneurysm (2605)
Event Date 05/11/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that post cryo ablation procedure, the patient presented with bilateral lower extremity swelling. The case was completed with cryo. The patient went to the emergency room, and a venous ultrasound was performed which confirmed a right groin pseudoaneurysm. A thrombin injection was then administered and the pseudoaneurysm resolved. No further patient complications have been reported as a result of this event. The patient was part of the (b)(6) clinical study.
 
Manufacturer Narrative
Product event summary: data files were returned and analyzed. Data files showed that 7 applications were performed with this catheter. There was no indication that the reported adverse events were related to manufacturing. The sheath was not returned for analysis/ investigation. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

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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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key7571323
MDR Text Key110141851
Report Number3002648230-2018-00359
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number64056
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 Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2018
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: 06/05/2018 Patient Sequence Number: 1
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