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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. LITEPAC RX PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number UNKNOWN LITEPAC
Device Problems Crack (1135); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review will be performed. The device has been returned for evaluation. The investigation confirmed the reported crack and material deformation. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicates that model unknown pta balloon dilatation catheter experienced a material deformation and crack. The information was received from a single source. The malfunction did not involve a patient. The male patient's age and weight were not provided.

 
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Brand NameLITEPAC RX PTA CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9955554
MDR Text Key194124003
Report Number9616666-2020-00033
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/13/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberUNKNOWN LITEPAC
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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