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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 68202087
Device Problems Inflation Problem (1310); Failure to Advance (2524)
Patient Problems Infiltration into Tissue (1931); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  Injury  
Event Description
It was reported that during a stent implantation procedure in carotid artery, the syringe allegedly could not enter into the tip of the balloon. It was further reported that infiltration occurred during external flushing of the balloon. The procedure was completed by using another device. The current status of the patient was unknown.
 
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 not been returned to the manufacturer for evaluation. However, a photo was provided for review. 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: 05/2024) device not returned.
 
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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 Key12915596
MDR Text Key286128560
Report Number9616666-2021-00219
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
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 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number68202087
Device Lot NumberCMFT0145
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2021 Patient Sequence Number: 1
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