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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 Delivered as Unsterile Product (1421)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2016
Event Type  malfunction  
Event Description
It was reported that prior to a cryoablation procedure, there was ¿dirt like black hair¿ in the white color plastic package case. The sheath was replaced and the case was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: returned photo showed ¿dirt like black hair¿ in the white color plastic package case. Visual inspection of the sheath showed the device was intact with no apparent issues. Deflection worked as per specification. Insertion and retraction tests and aspiration were performed with a balloon test catheter with no issues. No "black hair" or foreign material was observed.
 
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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 Key6210202
MDR Text Key63412982
Report Number3002648230-2016-00540
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 12/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/19/2018
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number30028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2016
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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