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

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER 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
 

CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 68202149
Device Problems Break (1069); Stretched (1601); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2021
Event Type  malfunction  
Event Description
It was reported that during preparation for a catheter placement procedure, the balloon of the device allegedly detached during removal of the protective cover. The procedure was completed using another device. There was no patient contact.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The catalog number identified has not been cleared in the us but is similar to the sleek rx pta catheter products that are cleared in the us. The pro code and 510 k number for the sleek rx pta catheter products are identified in common device name and pma/510k. (expiry date: 09/2023).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLITEPAC RX PTA CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13175964
MDR Text Key286563008
Report Number9616666-2021-00248
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number68202149
Device Lot NumberCMEX0161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-