• 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 ALPHA 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 ALPHA OTW PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number 50125220
Device Problems Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the sleek otw pta dilatation catheter that are cleared in the us. The pro code and 510 k number for the sleek otw pta dilatation catheter are identified. 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. However, photos were provided for review. The investigation of the reported event is currently underway. (expiry date: 02/2023).
 
Event Description
It was reported that during preparation for an angioplasty procedure, the shaft was allegedly damaged. It was further reported that the balloon was disconnected from rest of the catheter. The procedure was completed by using another device. There was no patient contact.
 
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the sleek otw pta dilatation catheter that are cleared in the us. The pro code and 510 k number for the sleek otw pta dilatation catheter are identified. 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. However, photos were provided for review. The investigation of the reported event is currently underway. (expiry date: 02/2023).
 
Event Description
It was reported that during preparation for an angioplasty procedure, the shaft was allegedly damaged. It was further reported that the balloon was disconnected from rest of the catheter. The procedure was completed by using another device. There was no patient contact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBANTAM ALPHA 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 Key13512466
MDR Text Key286333412
Report Number9616666-2022-00011
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K130786
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,Followup,Followup
Report Date 06/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number50125220
Device Lot NumberCMEQ0451
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-