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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 Problems Air Embolism (1697); ST Segment Elevation (2059)
Event Date 12/09/2014
Event Type  malfunction  
Manufacturer Narrative
Event summary: the patient data files did not show any system notices for the date of event. Files also showed at least fourteen injections were performed with catheter 2af284 / 70009-62. Upon visual inspection of flexcath advance sheath 4fc12 / 39914-18, results showed the device was intact with no apparent issues. The reported leaking valve/air ingress could not be reproduced. Multiple aspirations / injections were performed without air bubbles or leaks; hemostatic valve was leak tight. A clinical issue occurred and was resolved during procedure (st elevation / embolism). In conclusion, the reported issue (air ingress) has not been confirmed through testing. A clinical event occurred during procedure. Flexcath advance 4fc12 / 39914-18 passed the returned product inspection as per specification. 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, isolation of the pvs was conducted using the arctic front advance (number of ablations performed: three times to lspv, two times to lipv, two times to rspv, two times to ripv). After that, the sheath was pulled to the ra and cti was treated using a competitor product. To check the potentials in the pvs, the sheath was inserted into the la and the mapping catheter only was placed in the sheath. Disappearance of potentials was checked in the following order: lspv, the lipv and then ripv. Ecg showed st elevation in the ripv. Cag was therefore conducted. Neither stenosis nor air was confirmed there. Ten minutes later, st level went back to normal. Air was found below the pa valve through fluoroscopy during the cag performing. When the mapping catheter was inserted in the sheath, negative pressure was given to flush the sheath, but no further air was found. The patient's conscious level was normal. No abnormality was confirmed in his visual field or movements of the limbs and body. The patient had no breathing difficulty either. The case was completed with cryo. No further 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 Key6888399
MDR Text Key87863759
Report Number3002648230-2017-00528
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 distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 12/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2016
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number39914
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
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: 09/22/2017 Patient Sequence Number: 1
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