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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 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files for the date of the event were returned and analyzed. The files showed at least seventeen applications were performed with the balloon catheter without issue. The flexcath advance sheath, 4fc12 with lot 92460, was not returned for analysis. Therefore, the allegation of the sheath sterile barrier compromised could not be investigated. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary: the flexcath advance sheath 4fc12, with lot number 92460 was returned and analyzed. Visual inspection of the package showed the sterile pouch barrier was opened. The sheath was intact with no apparent issues. The sheath distal tip and dilator tip were intact, no fracture, breakage or kink were noticed. There was no teflon delamination noticed at the tip of the sheath. Functional test of the sheath showed the deflection worked as per specification. In conclusion, the sterile barrier issue was confirmed through testing and the sheath¿s pouch was not sealed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, the sheath pouch was not properly sealed and it was noted the sterile barrier was broken. The sheath was replaced. 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 Key6936779
MDR Text Key105823482
Report Number3002648230-2017-00556
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeAR
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 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number92460
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2017
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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