• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that two weeks post cryo ablation procedure, the patient returned to the hospital with a systemic infection and was critically ill. Blood cultures showed the infection was a skin based bacteria. It is unknown how the patient became infected during the procedure, although the physician suspected it may be related to the patient prep. It was later reported that the patient died. Further information received indicated that the physician noted that bacteria was possibly introduced to the patient during insertion of the product during the procedure. No further information is available at this time.
 
Manufacturer Narrative
Event summary: the patient data files showed at least twelve applications were performed with catheter 2af284/ 34418 on the date of the event without any issue. In conclusion, this is a clinical issue (death, bacterial infection) which occurred two weeks post procedure. There is no indication of relation of adverse event to the performance of the cryo device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Incoming information indicate that the access site was closed with a competitor device. The patient was found to have a vegetation on the mitral valve. It was noted that a possible cause of death was embolization of the mitral valve. Further incoming information indicated that prior to the death, the patient was admitted due to back pain and fever. The patient went into septic shock leading to the vegetation on the mitral valve.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Further information received indicated the bacteria was identified to be (b)(6). The patient's blood culture that was (b)(6) in 2 out of 2 bottles.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8162344
MDR Text Key130271363
Report Number3002648230-2018-00938
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/13/2018 Patient Sequence Number: 1
Treatment
2AF284 BALLOON CATHETER, 990063-020 MAPPING CATH
-
-