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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 68202149
Device Problems Deflation Problem (1149); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed. The return of the sample is pending. 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. (expiry date: 06/2024).
 
Event Description
It was reported that during an angioplasty procedure, the pta balloon was allegedly failed to deflate. There was no reported patient injury.
 
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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 Key13468613
MDR Text Key286023257
Report Number9616666-2022-00008
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
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 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number68202149
Device Lot NumberCMFU0395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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