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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 425-2515X
Device Problems Device Damaged Prior to Use ; Detachment of Device or device Component; Material Deformation
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 reported failure mode device damaged prior to use was confirmed during the investigation. The catheter was returned in two sections. There was a detachment noted at the proximal bond and outer, and the inner was torn off at the re-port. Indents were observed on the sleeve. The shipping mandrel was returned within in the device. A kink was observed on the shaft. The definitive root cause for the reported issues could not be determined based upon available information. It is unlikely that these defects are manufacturing related. A 100% visual inspection for catheter defects is performed on devices during catheter production. The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue. It is likely that handling or procedural techniques and excessive force during device preparation contributed to the reported event. Labeling review: ifu for sleek pta rapid exchange (rx) dilatation catheter product family was reviewed the following sections are applicable: description: a 0. 014¿ (0. 356 mm) guidewire is recommended for use with the sleek® catheters. 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 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. (b)(4).

 
Event Description

It was reported that during preparation, the pta dilatation catheter was allegedly torn and could not be used. There was no reported patient involvement.

 
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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 Key8226889
Report Number9616666-2018-00187
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number425-2515X
Device Catalogue Number425-2515X
Device LOT NumberCMBP0036
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/02/2017
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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