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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 Nonstandard Device (1420); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 04/06/2018
Event Type  malfunction  
Manufacturer Narrative
Event summary: the patient data files showed at least six injections were performed with catheter 2af283/31317 on the date of the event, system notice (b)(4) was received indicating that the safety system detected a compromised outer vacuum was triggered on application number six. Visual inspection of sheath, 4fc12/ 64100, showed the shaft was kinked and folded from the tip to 2. 77 inches in proximal from the tip. In conclusion, the reported system notice (b)(4) was received indicating that ¿the safety system detected a compromised outer vacuum¿ issue has been confirmed through data analysis. The sheath failed the product inspection due to shaft kink. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The sheath was returned to the manufacturer, analyzed, and tested out of specification.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7683393
MDR Text Key114458210
Report Number3002648230-2018-00481
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number64100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2018
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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