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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA DILATATION CATHETER Back to Search Results
Model Number 425-4022X
Device Problems Break; Material Rupture; Failure to Advance
Event Date 10/18/2017
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed. The lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the result of the investigation is inconclusive for the failure to advance failure mode reported. The definitive root cause for the reported advancement issue could not be determined based upon available information. The device was returned in 2 pieces and with extensive damage to the inner, outer and balloon. The evaluation confirmed a break at the report and a longitudinal rupture in the balloon. The nature of the ripped inner and subsequent balloon rupture would suggest that the users method of guidewire removal from the device was responsible for this damage. The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue. Patient conditions may have been a contributory factor in the reported event as there was stenosis in the tortuous and calcified lesion. Labeling review: ifu for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: description: the sleek® percutaneous transluminal angioplasty (pta) peripheral catheter family comprise a range of sizes of rapid exchange catheters for peripheral angioplasty. The catheter¿s proximal tubing is 304v stainless steel and the distal coaxial tubings are nylon co-polymer blend. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. A second lumen at the tip is used for advancing the guidewire. A 0. 014¿ (0. 356 mm) guidewire is recommended for use with the sleek® catheters. Warnings: do not advance the guidewire, balloon dilation catheter, or any component if resistance is met, without first determining the cause and taking remedial action. Precautions: carefully inspect the catheter prior to use to verify that the catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. If resistance is felt upon removal, then the balloon, guidewire and the sheath/ guide catheter should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly grasping the balloon catheter and sheath/guide catheter as a unit and withdrawing both together, using a gently twisting motion combined with traction. Directions for use: inspection and preparation remove the balloon sleeve by first withdrawing the shipping mandrel slightly and then slowly removing the sleeve while holding the catheter as close to the balloon as possible. If any resistance is felt, or if any stretching of the catheter is observed while removing the balloon sleeve, the product should not be used. The catheter should then be inspected for bends, kinks or stretched portions. Do not use if product damage is evident. (expiry date 05/2019).

 
Event Description

It was reported that the pta balloon dilatation catheter allegedly failed to cross the stenosis in a tortuous and calcified lesion via a contralateral approach. Reportedly, another device was used to complete the procedure. There was no reported patient injury.

 
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Brand NameSLEEK RX PTA DILATATION CATHETER
Type of DevicePTA 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
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key8086625
Report Number9616666-2018-00166
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 11/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number425-4022X
Device Catalogue Number425-4022X
Device LOT Number50140181
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/01/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/21/2016
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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