• 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 Problems Air Leak (1008); Fluid Leak (1250)
Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059)
Event Date 06/16/2017
Event Type  Injury  
Manufacturer Narrative
Event summary: the patient data files are not available for this product. This is a clinical issue encountered during the procedure. No product malfunction reported. Upon visual inspection of flexcath sheath 4fc12 / 96601-033, results showed the device was intact with no apparent issues. Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath. Dissection showed the hemostatic valve was leaking; valve was torn. The sheath failed the test due to leaking homeostatic valve. In conclusion, the reported issue (air ingress) has been confirmed through testing. The reported clinical issues (st-elevation, embolism, bp) were not confirmed through the testing. 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, after the pulmonary vein (pv) was isolated, a competitor mapping catheter was inserted into the sheath. St elevation was then observed and the blood pressure decreased. It was confirmed that an additional sheath was inserted that was a competitor product. Additionally, an embolism was confirmed by angiography and the sheath was flushed. Air ingress was then observed and air would continuously leak. The sheath was flushed with a salt solution and it was confirmed that the embolism resolved. The blood pressure then returned to normal. The case was completed with cryo. No further patient complications have been reported as a result of this event. It was further reported that the patient was intubated post procedure, which is the facility¿s normal process; however, a children¿s tracheal tube was used rather than an adult tube. The patient was discharged without further complications.
 
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 Key6699862
MDR Text Key105782752
Report Number3002648230-2017-00312
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
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number96601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2017
Was Device Evaluated by Manufacturer? Yes
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: 07/10/2017 Patient Sequence Number: 1
-
-