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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 04/18/2017
Event Type  malfunction  
Manufacturer Narrative
Event summary: the patient data files cannot confirm reported issue ¿sterility issue on sheath¿. The patient data files showed at least seven applications performed with catheter 2af284/73669-64 on the date the event. The returned product does not match the devices referenced in the complaint record. Only flexcath advance sheath package has been returned. After the visual inspection of package, a foreign object (length: 2. 5mm; width: 2mm) was confirmed in the package. The foreign object is already transferred to an individual plastic bag for the further analysis. Further failure material analysis will be completed to identify the component of the object. In conclusion, the reported issue "sterility issue on sheath" has been confirmed through testing. 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.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryoablation procedure, when the sheath was taken out of the package, ¿something such as black dust¿ was observed in the product package. It was unknown if the "dust" was in the package originally or after it was opened. The sheath was not replaced and was used in the procedure. 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6572419
MDR Text Key105644659
Report Number3002648230-2017-00224
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,Followup
Report Date 06/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/26/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number47539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2017
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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