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

MAUDE Adverse Event Report: CREAGH MEDICAL LTD. ADVANCE SERENITY 18 HYDROPHILLIC OTW PTA BALLOON CATHETER 018 HYDROPHILIC COATED OTW PTA BALLOON DILATATION 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
 

CREAGH MEDICAL LTD. ADVANCE SERENITY 18 HYDROPHILLIC OTW PTA BALLOON CATHETER 018 HYDROPHILIC COATED OTW PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number SER18-150-30-100
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2020
Event Type  malfunction  
Event Description
Balloon was used in the distal sfa. Upon the second inflation the balloon burst at 12 atm. No portion detached.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameADVANCE SERENITY 18 HYDROPHILLIC OTW PTA BALLOON CATHETER
Type of Device018 HYDROPHILIC COATED OTW PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CREAGH MEDICAL LTD.
ida business park
creagh road
ballinasloe, co. galway H53 K 8P4
EI H53 K8P4
Manufacturer (Section G)
CREAGH MEDICAL LTD.
ida business park
creagh road
ballinasloe, co. galway H53 K 8P4
EI H53 K8P4
Manufacturer Contact
michelle donnellan
ida business park
creagh road
ballinasloe, co. galway H53 K-8P4
EI   H53 K8P4
MDR Report Key10449007
MDR Text Key209815538
Report Number3005994106-2020-00090
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K180007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSER18-150-30-100
Device Lot Number22000955
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-