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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
Model Number 425-3022X
Device Problems Break; Difficult to Insert; Device-Device Incompatibility
Event Date 02/16/2018
Event Type  Malfunction  
Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The investigation is currently underway.

 
Event Description

It was reported that the shaft of the pta balloon catheter allegedly broke during insertion through the sheath. The device was removed without incident. There was no reported difficulty in retracting the catheter through the introducer sheath. There was no reported patient injury.

 
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Brand NameSLEEK RX PTA BALLOON DILATATION CATHETER
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
judith ludwig
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key7349597
Report Number9616666-2018-00029
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2019
Device MODEL Number425-3022X
Device Catalogue Number425-3022X
Device LOT Number50137782
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/15/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/19/2016
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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