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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK 3.0MM X 150MM L=155CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CLEARSTREAM TECHNOLOGIES LTD SLEEK 3.0MM X 150MM L=155CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2021
Event Type  Injury  
Event Description
As reported, during insertion, a sleek 3. 0mm x 150mm l
=
155cm balloon catheter was caught up on the strut of an unknown stent which caused the distal tip of the balloon to separate from the body of the balloon catheter. A second unknown stent was deployed to hold the remaining section of balloon in place. This was during a peripheral procedure in which the target vessel was the superficial femoral artery (sfa). The sleek balloon catheter was prepped per the instructions for use (ifu) and no anomalies were noted during the prep. No kinking or bending occurred prior to the separation of the balloon, and the balloon did not seem to stick to a stent. The device will not be returned for evaluation.
 
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Brand NameSLEEK 3.0MM X 150MM L=155CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD
moyne upper
enniscorthy
co. wexford Y21 Y 9T0
EI Y21 Y9T0
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD
enniscorthy
co. wexford
EI
Manufacturer Contact
karla castro
7863138372
MDR Report Key12916628
MDR Text Key286644551
Report Number1016427-2021-05384
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 12/02/2021
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 Model NumberN/A
Device Catalogue Number4253015X
Device Lot NumberCMFS0066
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/08/2021
Event Location Hospital
Date Report to Manufacturer12/02/2021
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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