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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 48510025
Device Problems Break (1069); Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2022
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the u. S. But, it is similar to the savvy long pta balloon dilatation catheter products that are cleared in the us. The 510 k number and pro code for the savvy long pta balloon dilatation catheter products 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. The investigation of the reported event is currently underway. (expiration date: 08/2023).
 
Event Description
It was reported that prior to a peripheral angioplasty procedure via a femoral access, the device allegedly leaked when the physician introduced the syringe into its point. It was further detected that the device was cracked. The procedure was completed using another device. There was no patient contact.
 
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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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13821309
MDR Text Key287555082
Report Number9616666-2022-00052
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,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number48510025
Device Lot NumberCMEW0060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
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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