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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 Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2017
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the data files for the date of the event were returned and analyzed. The files show at least ten applications with balloon catheter, 2af284 lot 17118, and eight applications with electrophysiology (ep) catheter, 239f3 lot 15994. No system notices or issues were noted. Further results pending the returned product analysis. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Event summary: upon visual inspection of flexcath sheath 4fc12 / 68329-053, results showed the device were intact with no apparent issues. Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath. The unable to aspirate report could not be reproduced. Dissection showed the hemostatic valve was leaking; valve was torn. The sheath failed the test due to leaking homeostatic valve. The sheath 4fc12 is flushed/aspirated upon inserting arctic front advance catheter. The od of the balloon proximal bonding was in specification (less than 0. 155 inches). Insertion and retraction tests were performed without friction. In conclusion, the reported issue air ingress during aspiration has been confirmed through testing but not through the data analysis. The reported issue (unable to aspirate) has been not confirmed through the testing and data analysis. The sheath failed the returned product inspection due to a leaking hemostatic valve. 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 cryo ablation procedure, when the sheath was flushed continuously, an ¿occlusion alarm¿ (alarm from the infusion pump) was triggered. A sheath port check confirmed air ingress. An attempt was made to perform air aspiration but a syringe was unable to be pulled out. The balloon catheter was thus extracted once and air aspiration was performed. Then, the balloon catheter was inserted again and no air was confirmed in the product. Ablation was started but the occlusion alarm was triggered multiple times. The procedure continued and 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 Key6827622
MDR Text Key105788602
Report Number3002648230-2017-00477
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 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/12/2019
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number68329
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/29/2017 Patient Sequence Number: 1
Treatment
2AF284 BALLOON CATHETER
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