• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CLEARSTREAM TECHNOLOGIES LTD. BANTAM OTW PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 48515025
Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2021
Event Type  malfunction  
Event Description
It was reported that during device preparation for a procedure, the balloon sleeve could not be removed. It was further reported that the another device was used to complete the procedure. There was no patient contact.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. The catalog number identified has not been cleared in the us but is similar to the savvy long products that are cleared in the us. The pro code and 510 k number for the savvy long products are identified. (expiry date: 01/2023).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12933719
MDR Text Key286332269
Report Number9616666-2021-00223
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K072947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48515025
Device Lot NumberCMEP0316
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
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

-
-