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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD SLEEK 2.0MM X 40MM L=150CM PTA DILATATION CATHETER

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CLEARSTREAM TECHNOLOGIES LTD SLEEK 2.0MM X 40MM L=150CM PTA DILATATION CATHETER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 01/19/2017
Event Type  Injury  
Event Description
During an interventional procedure, a 2. 0mm x 40mm l
=
150cm sleek percutaneous transluminal angioplasty (pta) balloon kinked and during repeated attempts to cross the lesion the kinked portion of the device became stuck in the blood vessel which was bleeding.   the physician stopped the bleeding and the procedure was completed.   the procedure completed on the same day with 40 minutes of prolongation.   it is unknown how the bleeding was stopped.  the product will be returned for analysis.   the target lesion was right anterior tibial artery (cto). The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The brand of sheath used in the procedure was a medikit (parent).   there was no damage noted to the box, pouch, hoop or balloon sleeve, no difficulty removing the balloon sleeve and no kinks noted on the device prior to use. The device prepped normally.  a guidewire (0. 014rubyhard) and a micro catheter (prominent, tokai medical) crossed the lesion. The sleek was attempted to cross but it could not cross the lesion. The physician tried to cross the catheter by pushing but he could not. Therefore the balloon was removed from the patient¿s body and confirmed that its shaft guide wire gw exit side got kinked in several portions. Furthermore bleeding to extravascular was confirmed from around exit portion of a sheath introducer (4. 5f) when the lesion was checked under contrast. The physician had tried to cross the lesion several times and found that the kinked part was stick in the blood vessel and bleeding. The physician stopped the bleeding and the procedure was completed.  the vessel damage was caused by the sleek device when attempting to cross and made perforation (vessel damage). The kink was occurred while it was used in the patient and that kink was confirmed after the removal of the complaint product.  additional procedural details were requested but are unknown.
 
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Brand NameSLEEK 2.0MM X 40MM L=150CM
Type of DevicePTA DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD
enniscorthy
co. wexford
EI
MDR Report Key6325708
MDR Text Key67248508
Report Number1016427-2017-00175
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Model NumberN/A
Device Catalogue Number4252004X
Device Lot Number50114062
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/13/2017
Distributor Facility Aware Date01/19/2017
Device Age27 MO
Event Location Hospital
Date Report to Manufacturer02/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/13/2017 Patient Sequence Number: 1
Treatment
SEE B5
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