• 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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2020
Event Type  malfunction  
Manufacturer Narrative
The 4fc12 sheath with lot 0010372191 was returned and analyzed. Visual inspection showed the device shaft was kinked close to the tip. Aspiration and flush testing did not show any air passing through the tube or expelled from the sheath distal tip. The pull wire was not broken. No teflon delamination was noticed at the tip of the shaft. In conclusion, the sheath failed the returned product inspection due to a kinked shaft. If information is provided in the future, a supplemental report will be issued.
 
Event Description
After a completed case, the sheath subsequently tested out of specification per the manufacturer's investigation.
 
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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11280334
MDR Text Key230613569
Report Number3002648230-2021-00056
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number0010372191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-