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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number UNKNOWN BANTAM
Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Material Deformation (2976); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
It was identified as part of a customer survey that post bantam pta balloon catheter use on over four thousand nine hundred and ninety patients, eight in ten cases were successful, two percentage had crush and migration after crush. It was unknown whether any re-intervention was performed. The current status of the patients was unknown.
 
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not 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 (ifu) 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. The catalog number identified has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us. The pro code and 510 k number for the savvy long pta dilatation catheter products are identified in common device name and pma/510k. Device not returned.
 
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Brand NameBANTAM 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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13658339
MDR Text Key286562808
Report Number9616666-2022-00033
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN BANTAM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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