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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 436-2522X
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported that during a procedure, the balloon allegedly ruptured during dilation. There was no reported patient injury.
 
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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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12157282
MDR Text Key261480810
Report Number9616666-2021-00105
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741132889
UDI-Public(01)00801741132889
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number436-2522X
Device Catalogue Number436-2522X
Device Lot NumberCMDR0193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2021 Patient Sequence Number: 1
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