• 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 SELECT STEERABLE SHEATH INTRODUCER, CATHETER

  • 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 SELECT STEERABLE SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number 990065
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  malfunction  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLEXCATH SELECT STEERABLE SHEATH
Type of DeviceINTRODUCER, CATHETER
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key15226536
Report Number3002648230-2022-00319
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00763000279905
UDI-Public00763000279905
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142684
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 08/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number990065
Device Catalogue Number990065
Device Lot Number0010878298
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2022
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-