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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 Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 07/02/2019
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least seven applications were performed with balloon catheter 2af284 with lot number 21662 without any issues present. In conclusion, the reported pulmonary vein damage could not be confirmed through analysis of data files. There is no indication of relation of adverse event to the performance of the cryo device. The sheath has been returned and physical analysis is pending. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, a coronary angiography was attempted; however, the contrast agent did not flow, and concentrated in one area. The physician determined the pulmonary vein was damaged. An intracardiac echocardiogram was performed, confirming there was no pericardial effusion. The case was completed with radiofrequency. The patient recovered at a later date. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the sheath 4fc12 with lot number 85382 was returned and analyzed. Visual inspection of the sheath showed that the shaft, was kinked at 7. 2 inches. The sheath tip was with no sharp edges. In conclusion, the reported clinical issue (pulmonary vein damage) occurred during cryo ablation procedure and cannot be confirmed through testing. The sheath failed the returned product inspection due to shaft kink. There is no indication of relation of the adverse event to the finding of the mapping catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary: the sheath 4fc12 with lot number 85382 was returned and analyzed. Visual inspection of the sheath showed that the shaft, was kinked at 7. 2 inches. The sheath tip was with no sharp edges. In conclusion, the reported clinical issue (pulmonary vein damage) occurred during cryo ablation procedure and cannot be confirmed through testing. The sheath failed the returned product inspection due to shaft kink. There is no indication of relation of the adverse event to the finding of the sheath. 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 Key8820029
MDR Text Key152010866
Report Number3002648230-2019-00525
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 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/15/2021
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number85382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2019
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: 07/23/2019 Patient Sequence Number: 1
Treatment
2AF284 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
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