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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 425-2004X
Device Problem Kinked (1339)
Patient Problem No Information (3190)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that the device failed to cross the lesion and kinked. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The complaint device and another device were inserted into the patient however the devices failed to cross the lesion and kinked. It was unknown how the procedure completed. The procedure completed successfully. There was no reported patient injury.
 
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Receipt of device is not expected. The investigation is currently in progress.
 
Event Description
It was reported that the device failed to cross the lesion and kinked. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The complaint device and another device were inserted into the patient however the devices failed to cross the lesion and kinked. It was unknown how the procedure completed. The procedure completed successfully. There was no reported patient injury.
 
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Brand NameSLEEK RX
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI
Manufacturer Contact
fiona nimhullain
539237111
MDR Report Key7133086
MDR Text Key247669131
Report Number9616666-2017-00153
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number425-2004X
Device Lot Number50136776
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2016
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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