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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 Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2016
Event Type  malfunction  
Manufacturer Narrative
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, while aspirating the sheath, there was a lot of air introduced. The air was visible on fluoroscopy. The sheath was replaced and the procedure was completed with cryo. No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the device, flexcath advance sheath 4fc12 with lot number 31829 (b)(4), and data files were returned and analyzed. The data files did not show any issues. Visual inspection of the sheath demonstrated the shaft was intact with no apparent issues. Multiple aspirations and injections were performed without air bubbles or leaks. The hemostatic valve and valve assembly were leak tight. In conclusion, the reported air ingress has not been confirmed through testing and could not be reproduced. The returned product passed the returned product inspection per 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key5521192
MDR Text Key148535272
Report Number3002648230-2016-00045
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/25/2017
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number31829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2015
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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