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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER PTA BALLOON DILATATION CATHETER

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CLEARSTREAM TECHNOLOGIES LTD. SAVVY LONG OTW PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number 436-2515X
Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
This report summarizes one malfunction. A review of the reported information indicates that model 436-2515x pta balloon dilatation catheter allegedly experienced material deformation, catheter stretched, packaging problem and detachment of device or device component. The information was received from a single source. This malfunction did not involve a patient as there was no patient contact. The female patient is (b)(6) and weighs (b)(6).
 
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Brand NameSAVVY LONG OTW 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 Key10715262
MDR Text Key212473680
Report Number9616666-2020-00097
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 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number436-2515X
Device Catalogue Number436-2515X
Device Lot NumberCMDS0495
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 Received09/30/2020
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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