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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 Gas/Air Leak (2946)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
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 introducing the balloon catheter into the sheath and aspirating, bubbles were noted being aspirated from the sheath.The sheath was replaced which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the sheath 4fc12 with lot 0010372188, was returned and analyzed.The sheath was intact with no apparent issues.The performance test with sentinel blackbelt leak tester revealed the pressure decay is in the acceptance range.The shaft and valve are leak tight with no apparent issue.The air aspiration issue was not reproduced.In conclusion, the sheath passed the returned product inspection per specification.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
FLEXCATH ADVANCE STEERABLE SHEATH
Type of Device
CATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA  H9R 5Z8
MDR Report Key10839243
MDR Text Key216376704
Report Number3002648230-2020-00593
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/16/2022
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010372188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Date Manufacturer Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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